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The importance of getting involved for gastroenterology
.
The evening before Advocacy Day, we discussed strategies for having a successful meeting on Capitol Hill with AGA staff (including Kathleen Teixeira, AGA vice president of government affairs, and Jonathan Sollish, AGA senior coordinator, public policy). We discussed having our “asks” supported with evidence, and “getting personal” about how these policy issues directly affect us and our patients. We also had the chance to hear from Rep. Jim McGovern (D-Mass.) and Sen. Roy Blunt (R-Mo.) , both of whom invited our questions. Both congressmen are friends of AGA, with McGovern serving as chair of the House Rules Committee, and Blunt serving as chair of the Senate Labor-HHS Subcommittee on Appropriations.
Advocacy Day began with a group breakfast during which we reviewed some of the policy issues of central importance to gastroenterology:
• Removing Barriers to the Colorectal Cancer Screening Act (HR1570/S668), which enjoys strong bipartisan support, would correct the “cost-sharing” problem of screening colonoscopies turning therapeutic (with polypectomy) for our Medicare patients, by waiving the coinsurance for screening colonoscopies – regardless of whether we remove polyps during these colonoscopies.
• Safe Step Act, HR2279, legislation introduced in the House, facilitates a common-sense and timely (72 hours or 24 hours if life-threatening) appeals process when our patients are subjected to step therapy (“fail first”) by insurers.
• Improving Seniors’ Timely Access to Care Act of 2019, HR3107, legislation in the House, eases onerous prior authorization burdens by promoting an electronic prior authorization process, ensuring requests are approved by qualified medical professionals who have specialty-specific experience, and mandating that plans report their rates of delays and denials.
• NIH research funding facilitates innovative research and supports young investigators in our field.
Full of enthusiasm, our six-strong North Carolina contingent (pictured, L-R, Ziad Gellad, MD, MPH, AGAF; David Leiman, MD, MSPH; Animesh Jain, MD; Anne Finefrock Peery, MD; Lisa Gangarosa, MD, AGAF, chair of the AGA Government Affairs Committee; and Amit Patel, MD) met with the offices of Rep. David Price (D-N.C.), and both North Carolina Senators, Richard Burr (R) and Thom Tillis (R) on Capitol Hill to convey our “asks.”
At Price’s office in the stately Rayburn House Office Building, we thanked his team for cosponsorship of H.R. 1570 and H.R. 2279. We also discussed the importance of increasing research funding by the AGA’s goal of $2.5 billion for NIH for fiscal year 2020, noting that a majority of our delegation has received NIH funding for our training and/or research activities. We also encouraged Price’s office to cosponsor H.R. 3107, sharing our personal experiences about the administrative toll of the prior authorization process for obtaining appropriate and recommended medications for our patients – in my case, swallowed topical corticosteroids for patients with eosinophilic esophagitis.
We moved on to Sen. Tillis’s office, where we thanked his office for cosponsorship of S. 668 but encouraged his office to cosponsor upcoming companion Senate legislation for H.R. 2279 and H.R. 3107. Our colleague capably conveyed how an inflammatory bowel disease (IBD) patient he saw recently may require a colectomy due to delays in appropriate treatment stemming from these regulatory processes. We also showed Tillis’s office how NIH funding generates significant economic activity in North Carolina, supporting jobs in our state.
After a quick stop at the U.S. Senate gift shop in the basement to buy souvenirs for our kids, our last meeting was with Sen. Burr’s office. There, we also thanked his office for cosponsorship of S. 668 but encouraged him to sign the “Dear Colleague” letter that Sen. Sherrod Brown, D-OH, has circulated asking CMS to address the colonoscopy cost-sharing “loophole.” We discussed the importance of cosponsoring upcoming companion Senate legislation for H.R. 2279 and H.R. 3107, sharing stories from our clinical practices about how these regulatory burdens have delayed treatment for our patients.
You can get involved, too.
AGA Advocacy Day was a tremendous experience, but it is not the only way AGA members can get involved and take action. The AGA Advocacy website, gastro.org/advocacy, provides more information on multiple avenues for advocacy. These include an online advocacy tool for sending templated letters on these issues to your elected officials.
Perhaps now more than ever, it is crucial that we get involved to support gastroenterology and advocate for our patients.
Dr. Patel is assistant professor, division of gastroenterology, Duke University, Cary, N.C.; member, AGA Clinical Guidelines Committee.
.
The evening before Advocacy Day, we discussed strategies for having a successful meeting on Capitol Hill with AGA staff (including Kathleen Teixeira, AGA vice president of government affairs, and Jonathan Sollish, AGA senior coordinator, public policy). We discussed having our “asks” supported with evidence, and “getting personal” about how these policy issues directly affect us and our patients. We also had the chance to hear from Rep. Jim McGovern (D-Mass.) and Sen. Roy Blunt (R-Mo.) , both of whom invited our questions. Both congressmen are friends of AGA, with McGovern serving as chair of the House Rules Committee, and Blunt serving as chair of the Senate Labor-HHS Subcommittee on Appropriations.
Advocacy Day began with a group breakfast during which we reviewed some of the policy issues of central importance to gastroenterology:
• Removing Barriers to the Colorectal Cancer Screening Act (HR1570/S668), which enjoys strong bipartisan support, would correct the “cost-sharing” problem of screening colonoscopies turning therapeutic (with polypectomy) for our Medicare patients, by waiving the coinsurance for screening colonoscopies – regardless of whether we remove polyps during these colonoscopies.
• Safe Step Act, HR2279, legislation introduced in the House, facilitates a common-sense and timely (72 hours or 24 hours if life-threatening) appeals process when our patients are subjected to step therapy (“fail first”) by insurers.
• Improving Seniors’ Timely Access to Care Act of 2019, HR3107, legislation in the House, eases onerous prior authorization burdens by promoting an electronic prior authorization process, ensuring requests are approved by qualified medical professionals who have specialty-specific experience, and mandating that plans report their rates of delays and denials.
• NIH research funding facilitates innovative research and supports young investigators in our field.
Full of enthusiasm, our six-strong North Carolina contingent (pictured, L-R, Ziad Gellad, MD, MPH, AGAF; David Leiman, MD, MSPH; Animesh Jain, MD; Anne Finefrock Peery, MD; Lisa Gangarosa, MD, AGAF, chair of the AGA Government Affairs Committee; and Amit Patel, MD) met with the offices of Rep. David Price (D-N.C.), and both North Carolina Senators, Richard Burr (R) and Thom Tillis (R) on Capitol Hill to convey our “asks.”
At Price’s office in the stately Rayburn House Office Building, we thanked his team for cosponsorship of H.R. 1570 and H.R. 2279. We also discussed the importance of increasing research funding by the AGA’s goal of $2.5 billion for NIH for fiscal year 2020, noting that a majority of our delegation has received NIH funding for our training and/or research activities. We also encouraged Price’s office to cosponsor H.R. 3107, sharing our personal experiences about the administrative toll of the prior authorization process for obtaining appropriate and recommended medications for our patients – in my case, swallowed topical corticosteroids for patients with eosinophilic esophagitis.
We moved on to Sen. Tillis’s office, where we thanked his office for cosponsorship of S. 668 but encouraged his office to cosponsor upcoming companion Senate legislation for H.R. 2279 and H.R. 3107. Our colleague capably conveyed how an inflammatory bowel disease (IBD) patient he saw recently may require a colectomy due to delays in appropriate treatment stemming from these regulatory processes. We also showed Tillis’s office how NIH funding generates significant economic activity in North Carolina, supporting jobs in our state.
After a quick stop at the U.S. Senate gift shop in the basement to buy souvenirs for our kids, our last meeting was with Sen. Burr’s office. There, we also thanked his office for cosponsorship of S. 668 but encouraged him to sign the “Dear Colleague” letter that Sen. Sherrod Brown, D-OH, has circulated asking CMS to address the colonoscopy cost-sharing “loophole.” We discussed the importance of cosponsoring upcoming companion Senate legislation for H.R. 2279 and H.R. 3107, sharing stories from our clinical practices about how these regulatory burdens have delayed treatment for our patients.
You can get involved, too.
AGA Advocacy Day was a tremendous experience, but it is not the only way AGA members can get involved and take action. The AGA Advocacy website, gastro.org/advocacy, provides more information on multiple avenues for advocacy. These include an online advocacy tool for sending templated letters on these issues to your elected officials.
Perhaps now more than ever, it is crucial that we get involved to support gastroenterology and advocate for our patients.
Dr. Patel is assistant professor, division of gastroenterology, Duke University, Cary, N.C.; member, AGA Clinical Guidelines Committee.
.
The evening before Advocacy Day, we discussed strategies for having a successful meeting on Capitol Hill with AGA staff (including Kathleen Teixeira, AGA vice president of government affairs, and Jonathan Sollish, AGA senior coordinator, public policy). We discussed having our “asks” supported with evidence, and “getting personal” about how these policy issues directly affect us and our patients. We also had the chance to hear from Rep. Jim McGovern (D-Mass.) and Sen. Roy Blunt (R-Mo.) , both of whom invited our questions. Both congressmen are friends of AGA, with McGovern serving as chair of the House Rules Committee, and Blunt serving as chair of the Senate Labor-HHS Subcommittee on Appropriations.
Advocacy Day began with a group breakfast during which we reviewed some of the policy issues of central importance to gastroenterology:
• Removing Barriers to the Colorectal Cancer Screening Act (HR1570/S668), which enjoys strong bipartisan support, would correct the “cost-sharing” problem of screening colonoscopies turning therapeutic (with polypectomy) for our Medicare patients, by waiving the coinsurance for screening colonoscopies – regardless of whether we remove polyps during these colonoscopies.
• Safe Step Act, HR2279, legislation introduced in the House, facilitates a common-sense and timely (72 hours or 24 hours if life-threatening) appeals process when our patients are subjected to step therapy (“fail first”) by insurers.
• Improving Seniors’ Timely Access to Care Act of 2019, HR3107, legislation in the House, eases onerous prior authorization burdens by promoting an electronic prior authorization process, ensuring requests are approved by qualified medical professionals who have specialty-specific experience, and mandating that plans report their rates of delays and denials.
• NIH research funding facilitates innovative research and supports young investigators in our field.
Full of enthusiasm, our six-strong North Carolina contingent (pictured, L-R, Ziad Gellad, MD, MPH, AGAF; David Leiman, MD, MSPH; Animesh Jain, MD; Anne Finefrock Peery, MD; Lisa Gangarosa, MD, AGAF, chair of the AGA Government Affairs Committee; and Amit Patel, MD) met with the offices of Rep. David Price (D-N.C.), and both North Carolina Senators, Richard Burr (R) and Thom Tillis (R) on Capitol Hill to convey our “asks.”
At Price’s office in the stately Rayburn House Office Building, we thanked his team for cosponsorship of H.R. 1570 and H.R. 2279. We also discussed the importance of increasing research funding by the AGA’s goal of $2.5 billion for NIH for fiscal year 2020, noting that a majority of our delegation has received NIH funding for our training and/or research activities. We also encouraged Price’s office to cosponsor H.R. 3107, sharing our personal experiences about the administrative toll of the prior authorization process for obtaining appropriate and recommended medications for our patients – in my case, swallowed topical corticosteroids for patients with eosinophilic esophagitis.
We moved on to Sen. Tillis’s office, where we thanked his office for cosponsorship of S. 668 but encouraged his office to cosponsor upcoming companion Senate legislation for H.R. 2279 and H.R. 3107. Our colleague capably conveyed how an inflammatory bowel disease (IBD) patient he saw recently may require a colectomy due to delays in appropriate treatment stemming from these regulatory processes. We also showed Tillis’s office how NIH funding generates significant economic activity in North Carolina, supporting jobs in our state.
After a quick stop at the U.S. Senate gift shop in the basement to buy souvenirs for our kids, our last meeting was with Sen. Burr’s office. There, we also thanked his office for cosponsorship of S. 668 but encouraged him to sign the “Dear Colleague” letter that Sen. Sherrod Brown, D-OH, has circulated asking CMS to address the colonoscopy cost-sharing “loophole.” We discussed the importance of cosponsoring upcoming companion Senate legislation for H.R. 2279 and H.R. 3107, sharing stories from our clinical practices about how these regulatory burdens have delayed treatment for our patients.
You can get involved, too.
AGA Advocacy Day was a tremendous experience, but it is not the only way AGA members can get involved and take action. The AGA Advocacy website, gastro.org/advocacy, provides more information on multiple avenues for advocacy. These include an online advocacy tool for sending templated letters on these issues to your elected officials.
Perhaps now more than ever, it is crucial that we get involved to support gastroenterology and advocate for our patients.
Dr. Patel is assistant professor, division of gastroenterology, Duke University, Cary, N.C.; member, AGA Clinical Guidelines Committee.
A letter from Dr. Robert S. Sandler, MPH, AGAF, Chair of the AGA Research Foundation
Dear Colleagues,
Join me in supporting talented investigators through a personal gift to the AGA Research Foundation.
As a member of the GI community, you understand the physical, emotional and financial costs of digestive diseases. And you understand the value of research to advance patient care. The gap in federal funding for research continues to grow. Many well-qualified young investigators cannot get government funding. Gifts to the AGA Research Foundation this year directly supported 52 talented investigators. Despite this success, over 200 other innovative and promising research ideas went unfunded.
That’s why I’m asking for your help.
Securing the future of the field is no small task. Every dollar is a step forward in helping to spark the scientific breakthroughs of today so clinicians will have the tools to improve care tomorrow.
Everyone benefits from GI research developed by dedicated investigators.
I invite you to help the AGA Research Foundation continue our efforts to fund and retain talented GI scientists whose research will impact the future care of patients. Donate today at www.gastro.org/donate.
Thank you for your generosity. Best wishes for a happy, healthy holiday season and successful New Year.
Dear Colleagues,
Join me in supporting talented investigators through a personal gift to the AGA Research Foundation.
As a member of the GI community, you understand the physical, emotional and financial costs of digestive diseases. And you understand the value of research to advance patient care. The gap in federal funding for research continues to grow. Many well-qualified young investigators cannot get government funding. Gifts to the AGA Research Foundation this year directly supported 52 talented investigators. Despite this success, over 200 other innovative and promising research ideas went unfunded.
That’s why I’m asking for your help.
Securing the future of the field is no small task. Every dollar is a step forward in helping to spark the scientific breakthroughs of today so clinicians will have the tools to improve care tomorrow.
Everyone benefits from GI research developed by dedicated investigators.
I invite you to help the AGA Research Foundation continue our efforts to fund and retain talented GI scientists whose research will impact the future care of patients. Donate today at www.gastro.org/donate.
Thank you for your generosity. Best wishes for a happy, healthy holiday season and successful New Year.
Dear Colleagues,
Join me in supporting talented investigators through a personal gift to the AGA Research Foundation.
As a member of the GI community, you understand the physical, emotional and financial costs of digestive diseases. And you understand the value of research to advance patient care. The gap in federal funding for research continues to grow. Many well-qualified young investigators cannot get government funding. Gifts to the AGA Research Foundation this year directly supported 52 talented investigators. Despite this success, over 200 other innovative and promising research ideas went unfunded.
That’s why I’m asking for your help.
Securing the future of the field is no small task. Every dollar is a step forward in helping to spark the scientific breakthroughs of today so clinicians will have the tools to improve care tomorrow.
Everyone benefits from GI research developed by dedicated investigators.
I invite you to help the AGA Research Foundation continue our efforts to fund and retain talented GI scientists whose research will impact the future care of patients. Donate today at www.gastro.org/donate.
Thank you for your generosity. Best wishes for a happy, healthy holiday season and successful New Year.
Top AGA Community patient cases
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:
1. Severe ulcerative colitis # IBD – A 41-year-old female patient with ulcerative colitis had a flare that didn’t improve with adalimumab and prednisone, and was admitted to the hospital with bloody stools and abdominal pain. The GI community discussed considerations for next steps and other tests to consider.
2. Unexplained diarrhea – Following the eQ&A with an AGA guideline coauthor on chronic diarrhea, this popular case follows a celiac disease patient on a gluten-free diet who continues to have significant diarrhea and fatigue.
3. Difficult ERCP – How would you handle an ERCP where the papilla is small and in a tricky location? View photos from your colleague’s scope and share your advice with the GI community.
Access these clinical cases and more discussions at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:
1. Severe ulcerative colitis # IBD – A 41-year-old female patient with ulcerative colitis had a flare that didn’t improve with adalimumab and prednisone, and was admitted to the hospital with bloody stools and abdominal pain. The GI community discussed considerations for next steps and other tests to consider.
2. Unexplained diarrhea – Following the eQ&A with an AGA guideline coauthor on chronic diarrhea, this popular case follows a celiac disease patient on a gluten-free diet who continues to have significant diarrhea and fatigue.
3. Difficult ERCP – How would you handle an ERCP where the papilla is small and in a tricky location? View photos from your colleague’s scope and share your advice with the GI community.
Access these clinical cases and more discussions at https://community.gastro.org/discussions.
Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:
1. Severe ulcerative colitis # IBD – A 41-year-old female patient with ulcerative colitis had a flare that didn’t improve with adalimumab and prednisone, and was admitted to the hospital with bloody stools and abdominal pain. The GI community discussed considerations for next steps and other tests to consider.
2. Unexplained diarrhea – Following the eQ&A with an AGA guideline coauthor on chronic diarrhea, this popular case follows a celiac disease patient on a gluten-free diet who continues to have significant diarrhea and fatigue.
3. Difficult ERCP – How would you handle an ERCP where the papilla is small and in a tricky location? View photos from your colleague’s scope and share your advice with the GI community.
Access these clinical cases and more discussions at https://community.gastro.org/discussions.
FDA transition to disposable component duodenoscopes — talking points for your patients
The U.S. Food and Drug Administration (FDA) recently released a safety communication recommending duodenoscope manufacturers and health care facilities move away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps – or to fully disposable duodenoscopes when they become available. This announcement may have already produced some questions among your patients when it comes to their procedures that use a duodenoscope, such as endoscopic retrograde cholangiopancreatography (ERCP).
Talking points:
• Duodenoscopes are an important tool used during an ERCP to help localize and treat abnormal issues in your bile duct system and pancreas, and possibly help you avoid surgery.
• The complex design of duodenoscopes can sometimes result in bacteria remaining in a small portion of the duodenoscope (the “elevator channel”) even after careful cleaning according to approved instructions. However, the chance of getting an identified “superbug infection” with a duodenoscope is very low, currently estimated at 1 per 20,000 ERCPs performed in more than 650,000 ERCP procedures each year in the U.S. FDA continues to work with duodenoscope manufacturers to provide strict guidelines for cleaning and disinfection of these tools.
• The switch to new duodenoscopes with disposable components will be slow and orderly to make sure that there are enough duodenoscopes to perform ERCPs so that patients who need this often life-saving procedure will still have access.
• Do not cancel or delay any planned procedure without first discussing the benefits and risks with me or another health care provider, as delaying the procedure and alternatives like surgery or radiologic intervention may be riskier than a timely ERCP.
• The esophagogastroduodenoscopy (EGD) procedure does not use the same tool that is used for ERCP. EGD uses a different endoscope than ERCP and has not been shown to have the same risk of infection because there is no “elevator channel.”
The U.S. Food and Drug Administration (FDA) recently released a safety communication recommending duodenoscope manufacturers and health care facilities move away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps – or to fully disposable duodenoscopes when they become available. This announcement may have already produced some questions among your patients when it comes to their procedures that use a duodenoscope, such as endoscopic retrograde cholangiopancreatography (ERCP).
Talking points:
• Duodenoscopes are an important tool used during an ERCP to help localize and treat abnormal issues in your bile duct system and pancreas, and possibly help you avoid surgery.
• The complex design of duodenoscopes can sometimes result in bacteria remaining in a small portion of the duodenoscope (the “elevator channel”) even after careful cleaning according to approved instructions. However, the chance of getting an identified “superbug infection” with a duodenoscope is very low, currently estimated at 1 per 20,000 ERCPs performed in more than 650,000 ERCP procedures each year in the U.S. FDA continues to work with duodenoscope manufacturers to provide strict guidelines for cleaning and disinfection of these tools.
• The switch to new duodenoscopes with disposable components will be slow and orderly to make sure that there are enough duodenoscopes to perform ERCPs so that patients who need this often life-saving procedure will still have access.
• Do not cancel or delay any planned procedure without first discussing the benefits and risks with me or another health care provider, as delaying the procedure and alternatives like surgery or radiologic intervention may be riskier than a timely ERCP.
• The esophagogastroduodenoscopy (EGD) procedure does not use the same tool that is used for ERCP. EGD uses a different endoscope than ERCP and has not been shown to have the same risk of infection because there is no “elevator channel.”
The U.S. Food and Drug Administration (FDA) recently released a safety communication recommending duodenoscope manufacturers and health care facilities move away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps – or to fully disposable duodenoscopes when they become available. This announcement may have already produced some questions among your patients when it comes to their procedures that use a duodenoscope, such as endoscopic retrograde cholangiopancreatography (ERCP).
Talking points:
• Duodenoscopes are an important tool used during an ERCP to help localize and treat abnormal issues in your bile duct system and pancreas, and possibly help you avoid surgery.
• The complex design of duodenoscopes can sometimes result in bacteria remaining in a small portion of the duodenoscope (the “elevator channel”) even after careful cleaning according to approved instructions. However, the chance of getting an identified “superbug infection” with a duodenoscope is very low, currently estimated at 1 per 20,000 ERCPs performed in more than 650,000 ERCP procedures each year in the U.S. FDA continues to work with duodenoscope manufacturers to provide strict guidelines for cleaning and disinfection of these tools.
• The switch to new duodenoscopes with disposable components will be slow and orderly to make sure that there are enough duodenoscopes to perform ERCPs so that patients who need this often life-saving procedure will still have access.
• Do not cancel or delay any planned procedure without first discussing the benefits and risks with me or another health care provider, as delaying the procedure and alternatives like surgery or radiologic intervention may be riskier than a timely ERCP.
• The esophagogastroduodenoscopy (EGD) procedure does not use the same tool that is used for ERCP. EGD uses a different endoscope than ERCP and has not been shown to have the same risk of infection because there is no “elevator channel.”
Talking to your patients about ranitidine
The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, which were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to what was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.
The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential effect on patients who have been taking ranitidine.
With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available.
Talking to your patients
The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that:
• Ranitidine is an H2 blocker (antihistamine) – available OTC and in prescription strength – used to prevent and relieve heartburn associated with acid indigestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
• Not all ranitidine medicines marketed in the United States are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• It might be prudent to hold off taking Zantac until a final FDA conclusion is released.
• Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
• Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco, or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.
The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, which were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to what was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.
The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential effect on patients who have been taking ranitidine.
With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available.
Talking to your patients
The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that:
• Ranitidine is an H2 blocker (antihistamine) – available OTC and in prescription strength – used to prevent and relieve heartburn associated with acid indigestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
• Not all ranitidine medicines marketed in the United States are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• It might be prudent to hold off taking Zantac until a final FDA conclusion is released.
• Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
• Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco, or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.
The FDA recently released several safety alerts on ranitidine formulations, including the brand-name drug Zantac, which were found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests and animal studies. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. This contaminant is similar to what was recently found in losartan, an angiotensin II receptor blocker used to treat hypertension, that was recalled by the FDA.
The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the potential effect on patients who have been taking ranitidine.
With the voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., as well as the voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp, your patients might be asking a lot of questions about whether to continue to using their medicines and what alternatives are available.
Talking to your patients
The FDA safety alerts have been covered by various media outlets since early September. This may cause your patients to question whether they should stay on or start using ranitidine products. When discussing the recall with your patients, let them know that:
• Ranitidine is an H2 blocker (antihistamine) – available OTC and in prescription strength – used to prevent and relieve heartburn associated with acid indigestion and sour stomach. It reduces stomach acid and works longer but not as quickly as antacids.
• Not all ranitidine medicines marketed in the United States are being recalled and the FDA is not recommending individuals stop taking all ranitidine medicines at this time.
• It might be prudent to hold off taking Zantac until a final FDA conclusion is released.
• Multiple drugs are approved for the same or similar uses as ranitidine. Other treatment options are available, both prescription and OTC, for patients who are concerned about ranitidine.
• Life-style modifications may reduce or eliminate the need for heartburn drugs for long-term use. These may include weight loss, avoiding tobacco, or a change in eating patterns. Share AGA’s patient education content on gastroesophageal reflux disease (GERD) for more tips for your patients.
Tell your patients these four things about prebiotics
Explaining prebiotics:
- • Prebiotics serve as food for specific microbes in the gut but their health benefits are likely due to broader changes in the function of communities of microbes.
- • Prebiotics can lead to a durable change in overall function of a gut microbial community with potential for long-term health benefit while probiotics are live microorganisms that when administered in adequate amounts can confer a health benefit even in the short term.
- • Prebiotics ferment to short-chain fatty acids known to positively influence human metabolism and immunity. Commercial prebiotics may be beneficial in some individuals but intolerable in others.
- • Further research is needed to determine the specificity of prebiotics in terms of their biological effects. Other dietary fibers/proteins may have similar health benefits that have not yet been determined.
These tips are from “Prebiotics 101,” the first of a four-part CME series in AGA University, agau.gastro.org, titled, “The Microbiome and Digestive Health: A Look at Prebiotics.” Part two, “Diet vs. Prebiotics” is also available.
Looking for more information on prebiotics?
AGA has educational materials for patients on probiotics (also available in Spanish) at gastro.org/patient.
Explaining prebiotics:
- • Prebiotics serve as food for specific microbes in the gut but their health benefits are likely due to broader changes in the function of communities of microbes.
- • Prebiotics can lead to a durable change in overall function of a gut microbial community with potential for long-term health benefit while probiotics are live microorganisms that when administered in adequate amounts can confer a health benefit even in the short term.
- • Prebiotics ferment to short-chain fatty acids known to positively influence human metabolism and immunity. Commercial prebiotics may be beneficial in some individuals but intolerable in others.
- • Further research is needed to determine the specificity of prebiotics in terms of their biological effects. Other dietary fibers/proteins may have similar health benefits that have not yet been determined.
These tips are from “Prebiotics 101,” the first of a four-part CME series in AGA University, agau.gastro.org, titled, “The Microbiome and Digestive Health: A Look at Prebiotics.” Part two, “Diet vs. Prebiotics” is also available.
Looking for more information on prebiotics?
AGA has educational materials for patients on probiotics (also available in Spanish) at gastro.org/patient.
Explaining prebiotics:
- • Prebiotics serve as food for specific microbes in the gut but their health benefits are likely due to broader changes in the function of communities of microbes.
- • Prebiotics can lead to a durable change in overall function of a gut microbial community with potential for long-term health benefit while probiotics are live microorganisms that when administered in adequate amounts can confer a health benefit even in the short term.
- • Prebiotics ferment to short-chain fatty acids known to positively influence human metabolism and immunity. Commercial prebiotics may be beneficial in some individuals but intolerable in others.
- • Further research is needed to determine the specificity of prebiotics in terms of their biological effects. Other dietary fibers/proteins may have similar health benefits that have not yet been determined.
These tips are from “Prebiotics 101,” the first of a four-part CME series in AGA University, agau.gastro.org, titled, “The Microbiome and Digestive Health: A Look at Prebiotics.” Part two, “Diet vs. Prebiotics” is also available.
Looking for more information on prebiotics?
AGA has educational materials for patients on probiotics (also available in Spanish) at gastro.org/patient.
AGA urges Medicare to fix CRC screening coinsurance issue
AGA and our sister societies met with Medicare staff in Washington, DC, to voice our opposition to its proposal that would require physicians to inform patients about potential colorectal cancer (CRC) screening costs. Under the proposal, physicians who plan to perform a CRC screening for a Medicare beneficiary must tell the beneficiary in advance that they may have to pay coinsurance under the Medicare program if the screening finds polyps that are removed as part of the screening procedure and document the conversation in the beneficiary’s medical record starting Jan. 1, 2020.
Under the Affordable Care Act, Medicare beneficiaries do not need to pay for screenings that receive an A or B from the U.S. Preventive Services Task Force (USPSTF), such as screening colonoscopy. However, because of Medicare’s interpretation of the coding rules, when a polyp is found and removed during a screening colonoscopy, it is considered a diagnostic procedure and the patient is required to pay the coinsurance. Medicare’s new proposal does not solve the underlying problem — fixing the coinsurance issue for Medicare beneficiaries; instead, it shifts responsibility to notify Medicare beneficiaries to the physician.
The gastroenterology community, together with patient advocates, has been asking CMS since 2011 to use its authority to fix the Medicare screening colonoscopy coinsurance problem. It was never the intention of Congress for polypectomy resulting from the initial screening to be excluded from the screening benefit. The Obama administration provided guidance for commercial plans on this screening benefit and stated that plans should not impose coinsurance since “removal of polyp is integral to the screening” and thus most private insurers recognize the benefit of waiving the coinsurance.
In our meeting with Medicare, we told them that beneficiaries should not be penalized because of the agency’s misinterpretation of Congress’ legislation. We also urged Medicare not to add to physician burden, to take responsibility for notifying patients of its own coverage and payment policies, and to focus on ways to help patients avoid unfair financial penalties resulting from its misinterpretation of Congress’s mandate for free CRC screening.
Medicare needs to hear from you today. Sign our letter on gastro.org/advocacy to let your voice be heard.
AGA and our sister societies met with Medicare staff in Washington, DC, to voice our opposition to its proposal that would require physicians to inform patients about potential colorectal cancer (CRC) screening costs. Under the proposal, physicians who plan to perform a CRC screening for a Medicare beneficiary must tell the beneficiary in advance that they may have to pay coinsurance under the Medicare program if the screening finds polyps that are removed as part of the screening procedure and document the conversation in the beneficiary’s medical record starting Jan. 1, 2020.
Under the Affordable Care Act, Medicare beneficiaries do not need to pay for screenings that receive an A or B from the U.S. Preventive Services Task Force (USPSTF), such as screening colonoscopy. However, because of Medicare’s interpretation of the coding rules, when a polyp is found and removed during a screening colonoscopy, it is considered a diagnostic procedure and the patient is required to pay the coinsurance. Medicare’s new proposal does not solve the underlying problem — fixing the coinsurance issue for Medicare beneficiaries; instead, it shifts responsibility to notify Medicare beneficiaries to the physician.
The gastroenterology community, together with patient advocates, has been asking CMS since 2011 to use its authority to fix the Medicare screening colonoscopy coinsurance problem. It was never the intention of Congress for polypectomy resulting from the initial screening to be excluded from the screening benefit. The Obama administration provided guidance for commercial plans on this screening benefit and stated that plans should not impose coinsurance since “removal of polyp is integral to the screening” and thus most private insurers recognize the benefit of waiving the coinsurance.
In our meeting with Medicare, we told them that beneficiaries should not be penalized because of the agency’s misinterpretation of Congress’ legislation. We also urged Medicare not to add to physician burden, to take responsibility for notifying patients of its own coverage and payment policies, and to focus on ways to help patients avoid unfair financial penalties resulting from its misinterpretation of Congress’s mandate for free CRC screening.
Medicare needs to hear from you today. Sign our letter on gastro.org/advocacy to let your voice be heard.
AGA and our sister societies met with Medicare staff in Washington, DC, to voice our opposition to its proposal that would require physicians to inform patients about potential colorectal cancer (CRC) screening costs. Under the proposal, physicians who plan to perform a CRC screening for a Medicare beneficiary must tell the beneficiary in advance that they may have to pay coinsurance under the Medicare program if the screening finds polyps that are removed as part of the screening procedure and document the conversation in the beneficiary’s medical record starting Jan. 1, 2020.
Under the Affordable Care Act, Medicare beneficiaries do not need to pay for screenings that receive an A or B from the U.S. Preventive Services Task Force (USPSTF), such as screening colonoscopy. However, because of Medicare’s interpretation of the coding rules, when a polyp is found and removed during a screening colonoscopy, it is considered a diagnostic procedure and the patient is required to pay the coinsurance. Medicare’s new proposal does not solve the underlying problem — fixing the coinsurance issue for Medicare beneficiaries; instead, it shifts responsibility to notify Medicare beneficiaries to the physician.
The gastroenterology community, together with patient advocates, has been asking CMS since 2011 to use its authority to fix the Medicare screening colonoscopy coinsurance problem. It was never the intention of Congress for polypectomy resulting from the initial screening to be excluded from the screening benefit. The Obama administration provided guidance for commercial plans on this screening benefit and stated that plans should not impose coinsurance since “removal of polyp is integral to the screening” and thus most private insurers recognize the benefit of waiving the coinsurance.
In our meeting with Medicare, we told them that beneficiaries should not be penalized because of the agency’s misinterpretation of Congress’ legislation. We also urged Medicare not to add to physician burden, to take responsibility for notifying patients of its own coverage and payment policies, and to focus on ways to help patients avoid unfair financial penalties resulting from its misinterpretation of Congress’s mandate for free CRC screening.
Medicare needs to hear from you today. Sign our letter on gastro.org/advocacy to let your voice be heard.
Include the AGA Research Foundation in your estate plan
Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime. Review these goals to turn financial aspiration into charitable action to achieve your philanthropic vision.
Goal: Take care of those you love
Use your will or living trust to clearly communicate your intentions for how you would like to provide for your loved ones and favorite causes, including the AGA Research Foundation. You can feel secure knowing you will maintain control of your assets until after your lifetime and that your gifts are revocable so you can change your mind at any time.
Goal: Eliminate capital gains tax on stocks
When you donate appreciated securities – that is, stocks you’ve owned for more than 1 year that are now worth more than you originally paid for them – you can benefit yourself and the AGA Research Foundation. You can reduce or even eliminate federal capital gains taxes on the stock transfer, and you may be entitled to a federal income tax charitable deduction.
Tip: There are a number of ways to give appreciated securities, such as outright giving or funding a charitable gift annuity or a charitable remainder trust.
Goal: Conserve today’s finances
Save critical funds now by naming the AGA Research Foundation as the beneficiary of all or a percentage (1%-100%) of your IRA. Leaving all or part of your IRA to charity after your lifetime dramatically lowers future taxes for your beneficiaries. Naming a charity, like the AGA Research Foundation, as a beneficiary can eliminate federal income taxes that could consume a substantial portion of your account.
Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or [email protected].
Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime. Review these goals to turn financial aspiration into charitable action to achieve your philanthropic vision.
Goal: Take care of those you love
Use your will or living trust to clearly communicate your intentions for how you would like to provide for your loved ones and favorite causes, including the AGA Research Foundation. You can feel secure knowing you will maintain control of your assets until after your lifetime and that your gifts are revocable so you can change your mind at any time.
Goal: Eliminate capital gains tax on stocks
When you donate appreciated securities – that is, stocks you’ve owned for more than 1 year that are now worth more than you originally paid for them – you can benefit yourself and the AGA Research Foundation. You can reduce or even eliminate federal capital gains taxes on the stock transfer, and you may be entitled to a federal income tax charitable deduction.
Tip: There are a number of ways to give appreciated securities, such as outright giving or funding a charitable gift annuity or a charitable remainder trust.
Goal: Conserve today’s finances
Save critical funds now by naming the AGA Research Foundation as the beneficiary of all or a percentage (1%-100%) of your IRA. Leaving all or part of your IRA to charity after your lifetime dramatically lowers future taxes for your beneficiaries. Naming a charity, like the AGA Research Foundation, as a beneficiary can eliminate federal income taxes that could consume a substantial portion of your account.
Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or [email protected].
Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime. Review these goals to turn financial aspiration into charitable action to achieve your philanthropic vision.
Goal: Take care of those you love
Use your will or living trust to clearly communicate your intentions for how you would like to provide for your loved ones and favorite causes, including the AGA Research Foundation. You can feel secure knowing you will maintain control of your assets until after your lifetime and that your gifts are revocable so you can change your mind at any time.
Goal: Eliminate capital gains tax on stocks
When you donate appreciated securities – that is, stocks you’ve owned for more than 1 year that are now worth more than you originally paid for them – you can benefit yourself and the AGA Research Foundation. You can reduce or even eliminate federal capital gains taxes on the stock transfer, and you may be entitled to a federal income tax charitable deduction.
Tip: There are a number of ways to give appreciated securities, such as outright giving or funding a charitable gift annuity or a charitable remainder trust.
Goal: Conserve today’s finances
Save critical funds now by naming the AGA Research Foundation as the beneficiary of all or a percentage (1%-100%) of your IRA. Leaving all or part of your IRA to charity after your lifetime dramatically lowers future taxes for your beneficiaries. Naming a charity, like the AGA Research Foundation, as a beneficiary can eliminate federal income taxes that could consume a substantial portion of your account.
Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or [email protected].
Update on duodenoscope reprocessing and infection control
Infection transmission from duodenoscopes is a serious and complex issue for our patients and our practices.
As previously shared with our members late last year, the U.S. Food and Drug Administration (FDA) reported on preliminary data from manufacturer testing of duodenoscopes following reprocessing (cleaning). The report showed that, in about 5% of cases, samples tested positive for “high concern” bacteria after the scopes had been reprocessed as recommended. According to FDA, these are bacteria that are more often associated with disease. The final results and more granular detail are expected later this year.
This is a serious and complex issue for our patients and our practices. Duodenoscopes are necessary for performing endoscopic retrograde cholangiopancreatography (ERCP). This minimally invasive procedure is typically performed in patients with diseases of the liver, pancreas, and gallbladder and obviates the necessity for more morbid surgical and radiologic procedures.
A recent article in The New York Times reviewing this issue largely understated the value of duodenoscopes and the procedure for which they are used. This is a potentially life-saving procedure for nearly 700,000 patients each year in the United States. When a doctor recommends ERCP, it often is because the patient is seriously ill, and the benefits of the procedure far outweigh the risks. ERCPs also spare patients more invasive alternatives, including surgery. Withdrawal of these instruments from the marketplace is simply not feasible and would be a major step backward in our ability to treat common and complex disease in the most beneficial manner.
We do agree and support the identification and development of safe and effective solutions that eliminate risk of infection transmission as a top priority. This cannot happen overnight: We cannot adopt new technologies, such as disposable duodenoscopes, without first understanding the new and unintentional risks we may be introducing to our patients such as an increased risk of procedural failure, perforation, or pancreatitis.
The GI societies have been working closely with FDA and industry to identify and properly vet potential solutions. FDA has already reviewed and cleared new reprocessing and sterilization technologies and revised designs for some duodenoscopes; all are intended to enhance ease of cleaning and reprocessing, thereby improving safety from transmitted infection. Other redesigns and new technologies for endoscope reprocessing, as well as single-use instruments, are in the pipeline. All of these options, and others, will likely enter the marketplace in the coming months and years after FDA vetting and approval and with postmarketing studies to ensure the efficacy of the technology and patient safety.
AGA is currently seeking feedback from AGA members to provide to FDA for consideration as they make upcoming review and approval decisions. If you are concerned about losing access to ERCP, a valuable procedure, please share your comments in the AGA Community. We will be sharing these comments with FDA to ensure their decisions reflect the needs of our members.
Since it was discovered several years ago that cases of infection transmission associated with duodenoscopes had been experienced by hospitals in the United States and Europe, health care organizations across the board recognized the need to escalate infection control efforts and to swiftly identify and disseminate best practices. FDA, the Centers for Disease Control and Prevention, state and local health departments, scope manufacturers, and medical societies have collaborated continuously to determine best practices for identifying and reporting sources of infection and effectively cleaning equipment.
Since this problem was identified, vigilance has been raised and infection rates have improved. As with all medical procedures, physicians should discuss the risks and benefits with their patients who require ERCP.
This article was developed in collaboration with American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA).
Infection transmission from duodenoscopes is a serious and complex issue for our patients and our practices.
As previously shared with our members late last year, the U.S. Food and Drug Administration (FDA) reported on preliminary data from manufacturer testing of duodenoscopes following reprocessing (cleaning). The report showed that, in about 5% of cases, samples tested positive for “high concern” bacteria after the scopes had been reprocessed as recommended. According to FDA, these are bacteria that are more often associated with disease. The final results and more granular detail are expected later this year.
This is a serious and complex issue for our patients and our practices. Duodenoscopes are necessary for performing endoscopic retrograde cholangiopancreatography (ERCP). This minimally invasive procedure is typically performed in patients with diseases of the liver, pancreas, and gallbladder and obviates the necessity for more morbid surgical and radiologic procedures.
A recent article in The New York Times reviewing this issue largely understated the value of duodenoscopes and the procedure for which they are used. This is a potentially life-saving procedure for nearly 700,000 patients each year in the United States. When a doctor recommends ERCP, it often is because the patient is seriously ill, and the benefits of the procedure far outweigh the risks. ERCPs also spare patients more invasive alternatives, including surgery. Withdrawal of these instruments from the marketplace is simply not feasible and would be a major step backward in our ability to treat common and complex disease in the most beneficial manner.
We do agree and support the identification and development of safe and effective solutions that eliminate risk of infection transmission as a top priority. This cannot happen overnight: We cannot adopt new technologies, such as disposable duodenoscopes, without first understanding the new and unintentional risks we may be introducing to our patients such as an increased risk of procedural failure, perforation, or pancreatitis.
The GI societies have been working closely with FDA and industry to identify and properly vet potential solutions. FDA has already reviewed and cleared new reprocessing and sterilization technologies and revised designs for some duodenoscopes; all are intended to enhance ease of cleaning and reprocessing, thereby improving safety from transmitted infection. Other redesigns and new technologies for endoscope reprocessing, as well as single-use instruments, are in the pipeline. All of these options, and others, will likely enter the marketplace in the coming months and years after FDA vetting and approval and with postmarketing studies to ensure the efficacy of the technology and patient safety.
AGA is currently seeking feedback from AGA members to provide to FDA for consideration as they make upcoming review and approval decisions. If you are concerned about losing access to ERCP, a valuable procedure, please share your comments in the AGA Community. We will be sharing these comments with FDA to ensure their decisions reflect the needs of our members.
Since it was discovered several years ago that cases of infection transmission associated with duodenoscopes had been experienced by hospitals in the United States and Europe, health care organizations across the board recognized the need to escalate infection control efforts and to swiftly identify and disseminate best practices. FDA, the Centers for Disease Control and Prevention, state and local health departments, scope manufacturers, and medical societies have collaborated continuously to determine best practices for identifying and reporting sources of infection and effectively cleaning equipment.
Since this problem was identified, vigilance has been raised and infection rates have improved. As with all medical procedures, physicians should discuss the risks and benefits with their patients who require ERCP.
This article was developed in collaboration with American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA).
Infection transmission from duodenoscopes is a serious and complex issue for our patients and our practices.
As previously shared with our members late last year, the U.S. Food and Drug Administration (FDA) reported on preliminary data from manufacturer testing of duodenoscopes following reprocessing (cleaning). The report showed that, in about 5% of cases, samples tested positive for “high concern” bacteria after the scopes had been reprocessed as recommended. According to FDA, these are bacteria that are more often associated with disease. The final results and more granular detail are expected later this year.
This is a serious and complex issue for our patients and our practices. Duodenoscopes are necessary for performing endoscopic retrograde cholangiopancreatography (ERCP). This minimally invasive procedure is typically performed in patients with diseases of the liver, pancreas, and gallbladder and obviates the necessity for more morbid surgical and radiologic procedures.
A recent article in The New York Times reviewing this issue largely understated the value of duodenoscopes and the procedure for which they are used. This is a potentially life-saving procedure for nearly 700,000 patients each year in the United States. When a doctor recommends ERCP, it often is because the patient is seriously ill, and the benefits of the procedure far outweigh the risks. ERCPs also spare patients more invasive alternatives, including surgery. Withdrawal of these instruments from the marketplace is simply not feasible and would be a major step backward in our ability to treat common and complex disease in the most beneficial manner.
We do agree and support the identification and development of safe and effective solutions that eliminate risk of infection transmission as a top priority. This cannot happen overnight: We cannot adopt new technologies, such as disposable duodenoscopes, without first understanding the new and unintentional risks we may be introducing to our patients such as an increased risk of procedural failure, perforation, or pancreatitis.
The GI societies have been working closely with FDA and industry to identify and properly vet potential solutions. FDA has already reviewed and cleared new reprocessing and sterilization technologies and revised designs for some duodenoscopes; all are intended to enhance ease of cleaning and reprocessing, thereby improving safety from transmitted infection. Other redesigns and new technologies for endoscope reprocessing, as well as single-use instruments, are in the pipeline. All of these options, and others, will likely enter the marketplace in the coming months and years after FDA vetting and approval and with postmarketing studies to ensure the efficacy of the technology and patient safety.
AGA is currently seeking feedback from AGA members to provide to FDA for consideration as they make upcoming review and approval decisions. If you are concerned about losing access to ERCP, a valuable procedure, please share your comments in the AGA Community. We will be sharing these comments with FDA to ensure their decisions reflect the needs of our members.
Since it was discovered several years ago that cases of infection transmission associated with duodenoscopes had been experienced by hospitals in the United States and Europe, health care organizations across the board recognized the need to escalate infection control efforts and to swiftly identify and disseminate best practices. FDA, the Centers for Disease Control and Prevention, state and local health departments, scope manufacturers, and medical societies have collaborated continuously to determine best practices for identifying and reporting sources of infection and effectively cleaning equipment.
Since this problem was identified, vigilance has been raised and infection rates have improved. As with all medical procedures, physicians should discuss the risks and benefits with their patients who require ERCP.
This article was developed in collaboration with American Society for Gastrointestinal Endoscopy (ASGE) and the Society of Gastroenterology Nurses and Associates (SGNA).
8 new insights about diet and gut health
Three experts share their takeaways from the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease.
During your 4 years of medical school, you likely received only 4 hours of nutrition training. Yet we know diet is integral to the care of GI patients. That’s why AGA focused the 2019 James W. Freston Conference on the topic of food.
Our course directors William Chey, MD, AGAF, Sheila E. Crowe, MD, AGAF, and Gerard E. Mullin, MD, AGAF, share eight points from the meeting that stuck with them and can help all practicing GIs as they consider dietary treatments for their patients.
• 1. Personalized nutrition is important. Genetic differences lead to differences in health outcomes. One size or recommendation does not fit all. This is why certain diets only work on certain people. There is no one diet for all and for all disease states. Genetic tests can be helpful, but they rely on reporting that isn’t readily available yet.
• 2. Dietary therapy is key to managing eosinophilic esophagitis (EoE). EoE is becoming more and more prevalent. Genes can’t change that fast, but epigenetic factors can, and the evidence seems to be in food. EoE is not an IgE-mediated disease and therefore most allergy tests will not prove useful; however, food is often the trigger — most common, dairy. Dietary therapy is likely the best way to manage. You want to reduce the number of eliminated foods by way of a reintroduction protocol. The six-food elimination diet is standard, though some are moving to a four-food elimination diet (dairy, wheat, egg and soy).
• 3. There has been a reported increase in those with food allergies, sensitivities, celiac disease, and other adverse reactions to food. Many of the food allergy tests available are not helpful. In addition, many afflicted patients are conducting self-imposed diets rather than working with a GI, allergist, or dietitian. This needs to change.
• 4. There is currently insufficient evidence to support a gluten-free diet for irritable bowel syndrome (IBS). It is possible that fructans, more than gluten, are causing the GI issues. Typically, the low-FODMAP diet is beneficial to IBS patients if done correctly with the guidance of a dietitian; however, not everyone with IBS improves on it. All the steps are important though, including reintroduction and maintenance.
•5. When working with patients on the low-FODMAP or other restrictive diets, it is important to know their food and eating history. Avoidance/Restrictive Food Intake Disorder (ARFID) is something we need to be aware of when it comes to patients with a history or likelihood to develop disordered eating/eating disorders. The patient team may need to include an eating disorder therapist.
•6. The general population in the U.S. has increased the adoption of a gluten-free diet although the number of cases of celiac disease has not increased. Many have self-reported gluten sensitivities. Those that have removed gluten following trends are more at risk of bowel irregularity (low fiber), weight gain, and disordered eating. Celiac disease is not a do-it-yourself disease, patients will be best served working with a dietitian and GI.
• 7. Food can induce symptoms in patients with inflammatory bowel disease (IBD). It can also trigger gut inflammation resulting in incident or relapse. There is experimental plausibility for some factors of the relationship to be causal and we may be able to modify the diet to prevent and manage IBD.
• 8. The focus on nutrition education must continue! Nutrition should be a required part of continuing medical education for physicians. And physicians should work with dietitians to improve the care of GI patients.
For resources to help your patients understand how diet and nutrition can affect their digestive health, visit the AGA GI Patient Center, gastro.org/patient. Each disease-based resource provides tips from leading experts on the role of diet in managing GI health.
The 2019 James W. Freston Single Topic Conference took place Aug. 9 and 10 in Chicago. The Freston conference is the only conference organized by the AGA Institute Council in which the agenda is determined through an open call for proposals from AGA membership. The purpose of the conference is to focus on scientific dialogue, present opportunities for scientific collaboration, and explore new ideas that may lead to enhanced patient therapies or potential opportunities for cures of digestive diseases. The 2019 conference was sponsored by the AGA Institute Council Obesity, Metabolism & Nutrition Section. Vice chair of the section, Dr. Gerard Mullin, served as co-course director.
Three experts share their takeaways from the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease.
During your 4 years of medical school, you likely received only 4 hours of nutrition training. Yet we know diet is integral to the care of GI patients. That’s why AGA focused the 2019 James W. Freston Conference on the topic of food.
Our course directors William Chey, MD, AGAF, Sheila E. Crowe, MD, AGAF, and Gerard E. Mullin, MD, AGAF, share eight points from the meeting that stuck with them and can help all practicing GIs as they consider dietary treatments for their patients.
• 1. Personalized nutrition is important. Genetic differences lead to differences in health outcomes. One size or recommendation does not fit all. This is why certain diets only work on certain people. There is no one diet for all and for all disease states. Genetic tests can be helpful, but they rely on reporting that isn’t readily available yet.
• 2. Dietary therapy is key to managing eosinophilic esophagitis (EoE). EoE is becoming more and more prevalent. Genes can’t change that fast, but epigenetic factors can, and the evidence seems to be in food. EoE is not an IgE-mediated disease and therefore most allergy tests will not prove useful; however, food is often the trigger — most common, dairy. Dietary therapy is likely the best way to manage. You want to reduce the number of eliminated foods by way of a reintroduction protocol. The six-food elimination diet is standard, though some are moving to a four-food elimination diet (dairy, wheat, egg and soy).
• 3. There has been a reported increase in those with food allergies, sensitivities, celiac disease, and other adverse reactions to food. Many of the food allergy tests available are not helpful. In addition, many afflicted patients are conducting self-imposed diets rather than working with a GI, allergist, or dietitian. This needs to change.
• 4. There is currently insufficient evidence to support a gluten-free diet for irritable bowel syndrome (IBS). It is possible that fructans, more than gluten, are causing the GI issues. Typically, the low-FODMAP diet is beneficial to IBS patients if done correctly with the guidance of a dietitian; however, not everyone with IBS improves on it. All the steps are important though, including reintroduction and maintenance.
•5. When working with patients on the low-FODMAP or other restrictive diets, it is important to know their food and eating history. Avoidance/Restrictive Food Intake Disorder (ARFID) is something we need to be aware of when it comes to patients with a history or likelihood to develop disordered eating/eating disorders. The patient team may need to include an eating disorder therapist.
•6. The general population in the U.S. has increased the adoption of a gluten-free diet although the number of cases of celiac disease has not increased. Many have self-reported gluten sensitivities. Those that have removed gluten following trends are more at risk of bowel irregularity (low fiber), weight gain, and disordered eating. Celiac disease is not a do-it-yourself disease, patients will be best served working with a dietitian and GI.
• 7. Food can induce symptoms in patients with inflammatory bowel disease (IBD). It can also trigger gut inflammation resulting in incident or relapse. There is experimental plausibility for some factors of the relationship to be causal and we may be able to modify the diet to prevent and manage IBD.
• 8. The focus on nutrition education must continue! Nutrition should be a required part of continuing medical education for physicians. And physicians should work with dietitians to improve the care of GI patients.
For resources to help your patients understand how diet and nutrition can affect their digestive health, visit the AGA GI Patient Center, gastro.org/patient. Each disease-based resource provides tips from leading experts on the role of diet in managing GI health.
The 2019 James W. Freston Single Topic Conference took place Aug. 9 and 10 in Chicago. The Freston conference is the only conference organized by the AGA Institute Council in which the agenda is determined through an open call for proposals from AGA membership. The purpose of the conference is to focus on scientific dialogue, present opportunities for scientific collaboration, and explore new ideas that may lead to enhanced patient therapies or potential opportunities for cures of digestive diseases. The 2019 conference was sponsored by the AGA Institute Council Obesity, Metabolism & Nutrition Section. Vice chair of the section, Dr. Gerard Mullin, served as co-course director.
Three experts share their takeaways from the 2019 James W. Freston Conference: Food at the Intersection of Gut Health and Disease.
During your 4 years of medical school, you likely received only 4 hours of nutrition training. Yet we know diet is integral to the care of GI patients. That’s why AGA focused the 2019 James W. Freston Conference on the topic of food.
Our course directors William Chey, MD, AGAF, Sheila E. Crowe, MD, AGAF, and Gerard E. Mullin, MD, AGAF, share eight points from the meeting that stuck with them and can help all practicing GIs as they consider dietary treatments for their patients.
• 1. Personalized nutrition is important. Genetic differences lead to differences in health outcomes. One size or recommendation does not fit all. This is why certain diets only work on certain people. There is no one diet for all and for all disease states. Genetic tests can be helpful, but they rely on reporting that isn’t readily available yet.
• 2. Dietary therapy is key to managing eosinophilic esophagitis (EoE). EoE is becoming more and more prevalent. Genes can’t change that fast, but epigenetic factors can, and the evidence seems to be in food. EoE is not an IgE-mediated disease and therefore most allergy tests will not prove useful; however, food is often the trigger — most common, dairy. Dietary therapy is likely the best way to manage. You want to reduce the number of eliminated foods by way of a reintroduction protocol. The six-food elimination diet is standard, though some are moving to a four-food elimination diet (dairy, wheat, egg and soy).
• 3. There has been a reported increase in those with food allergies, sensitivities, celiac disease, and other adverse reactions to food. Many of the food allergy tests available are not helpful. In addition, many afflicted patients are conducting self-imposed diets rather than working with a GI, allergist, or dietitian. This needs to change.
• 4. There is currently insufficient evidence to support a gluten-free diet for irritable bowel syndrome (IBS). It is possible that fructans, more than gluten, are causing the GI issues. Typically, the low-FODMAP diet is beneficial to IBS patients if done correctly with the guidance of a dietitian; however, not everyone with IBS improves on it. All the steps are important though, including reintroduction and maintenance.
•5. When working with patients on the low-FODMAP or other restrictive diets, it is important to know their food and eating history. Avoidance/Restrictive Food Intake Disorder (ARFID) is something we need to be aware of when it comes to patients with a history or likelihood to develop disordered eating/eating disorders. The patient team may need to include an eating disorder therapist.
•6. The general population in the U.S. has increased the adoption of a gluten-free diet although the number of cases of celiac disease has not increased. Many have self-reported gluten sensitivities. Those that have removed gluten following trends are more at risk of bowel irregularity (low fiber), weight gain, and disordered eating. Celiac disease is not a do-it-yourself disease, patients will be best served working with a dietitian and GI.
• 7. Food can induce symptoms in patients with inflammatory bowel disease (IBD). It can also trigger gut inflammation resulting in incident or relapse. There is experimental plausibility for some factors of the relationship to be causal and we may be able to modify the diet to prevent and manage IBD.
• 8. The focus on nutrition education must continue! Nutrition should be a required part of continuing medical education for physicians. And physicians should work with dietitians to improve the care of GI patients.
For resources to help your patients understand how diet and nutrition can affect their digestive health, visit the AGA GI Patient Center, gastro.org/patient. Each disease-based resource provides tips from leading experts on the role of diet in managing GI health.
The 2019 James W. Freston Single Topic Conference took place Aug. 9 and 10 in Chicago. The Freston conference is the only conference organized by the AGA Institute Council in which the agenda is determined through an open call for proposals from AGA membership. The purpose of the conference is to focus on scientific dialogue, present opportunities for scientific collaboration, and explore new ideas that may lead to enhanced patient therapies or potential opportunities for cures of digestive diseases. The 2019 conference was sponsored by the AGA Institute Council Obesity, Metabolism & Nutrition Section. Vice chair of the section, Dr. Gerard Mullin, served as co-course director.