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Helping patients with addictions get, stay clean
Roughly 6 months ago, a primary care physician referred a patient to our clinic for an assessment for opioid use disorder and a recommendation for treatment. The patient estimated, likely underestimated, his daily heroin use to five bags and dropped positive, in addition to heroin, for benzodiazepines, amphetamines, and cannabis. He was in a profession in which public safety was a critical concern, and he refused to notify his employer’s employee assistance program. He also declined to voluntarily admit himself for detox and treatment at the local, fully accredited addiction program, which was affiliated with a major university medical center. Instead, after an Internet search, the patient opted for an opioid treatment center featuring massage therapy, acupuncture, a stable, a sweat lodge – and a magnificent view of the Pacific Ocean.
Mental health professionals and lay people alike are aware of the “opioid crisis” – the derailment of lives, the devastation to communities, the death toll. But despite proposals to increase research funding, policies aimed at tightening the prescribing of opioids, and pledges to ramp up interdiction of heroin traffic, there is often an ignorance and confusion regarding the best, evidence-based approaches to getting patients with substance use disorders clean and keeping them clean.
Unfortunately, as with any crisis, there will be opportunists preying on vulnerable patients and their families. And this travesty has reportedly escalated, as outpatient treatment centers take advantage of laws guaranteeing mental health parity and insurance companies paying out tens of thousands of dollars for residential and outpatient opioid treatment. The potential for significant profit is plainly illustrated by the influx of private equity firms, such as Bain Capital, that are investing heavily in treatment centers.
Reports of malfeasance and misconduct, by owners, operators, staff, and others connected with the industry are beginning to get the attention of authorities. There have been reports of outpatient treatment centers that spend lavishly on furnishing, on BMWs and signed art, yet are understaffed, leading to inadequate one-on-one counseling and even sexual transgressions between residents. There are centers that have been investigated for insurance fraud, such as illegally waiving a copay or a deductible or for charging up to $5,000 for a simple urine five drug screen, often multiple times a day. And there is evidence of “junkie hunters” who cruise for people with addictions and brokers who provide such people with fake addresses in order to qualify for insurance plans with excellent benefits for addiction treatment.
Probably the best means to find a suitable outpatient treatment center is by way of a local, experienced, and respected chemical dependency counselor or physician certified in addiction medicine. If people with substance use disorders and their families want to independently conduct a search, as a good rule of thumb, they should be advised to consider programs affiliated with major medical centers and hospitals or outpatient treatment centers that have been established in good standing for years, in contrast to the rash of pop-up, for-profit programs. Of equal, or even greater importance, is that the prospective center ought to be accredited by a national organization, for example, The Joint Commission, and its staff ought to be licensed and credentialed as well.
In addition, there is merit if the staff has been educated, trained, and supervised under the direction of a respected institution. Needless to add, an outpatient treatment center must use evidence-based practices as the bedrock of treatment; this includes pharmacotherapies such as Suboxone and naltrexone (Vivitrol), and behavioral therapies such as cognitive-behavioral therapy, contingency management, and motivational enhancement. To date, massage and essential oils might be relaxing and pleasurable, but they are not considered accepted standard of care.
It is crucial, too, that an outpatient treatment center have both the resources to reliably handle acute medical detox, which can be a potentially life-threatening emergency, and the medical personnel who can assess and treat such medical conditions as hypertension as well as psychiatric illnesses such as bipolar and generalized anxiety disorders. A prospective patient also should inquire whether any of the staff has been the subject of disciplinary action by a licensing board or whether the center has been investigated by the state or a national accrediting organization.
Because addiction so often has facets rooted in the family system, and recovery so often depends on family support, an outpatient treatment center should provide a structured family program integrated into the patient’s treatment and emphasize the importance of continued family involvement after discharge.
Lastly, the best treatment centers often regularly update a patient’s local therapist and physician, spell out the elements of successful aftercare (12-step programs, and so on), and provide amenities, such as calls to a recently discharged patient and an alumni support network.
Dr. Marseille is a psychiatrist who works on the staff of a clinic in Wheaton, Ill. His special interests include adolescent and addiction medicine, eating disorders, trauma, bipolar disorder, and the psychiatric manifestations of acute and chronic medical conditions.
This article was updated 12/15/17.
Roughly 6 months ago, a primary care physician referred a patient to our clinic for an assessment for opioid use disorder and a recommendation for treatment. The patient estimated, likely underestimated, his daily heroin use to five bags and dropped positive, in addition to heroin, for benzodiazepines, amphetamines, and cannabis. He was in a profession in which public safety was a critical concern, and he refused to notify his employer’s employee assistance program. He also declined to voluntarily admit himself for detox and treatment at the local, fully accredited addiction program, which was affiliated with a major university medical center. Instead, after an Internet search, the patient opted for an opioid treatment center featuring massage therapy, acupuncture, a stable, a sweat lodge – and a magnificent view of the Pacific Ocean.
Mental health professionals and lay people alike are aware of the “opioid crisis” – the derailment of lives, the devastation to communities, the death toll. But despite proposals to increase research funding, policies aimed at tightening the prescribing of opioids, and pledges to ramp up interdiction of heroin traffic, there is often an ignorance and confusion regarding the best, evidence-based approaches to getting patients with substance use disorders clean and keeping them clean.
Unfortunately, as with any crisis, there will be opportunists preying on vulnerable patients and their families. And this travesty has reportedly escalated, as outpatient treatment centers take advantage of laws guaranteeing mental health parity and insurance companies paying out tens of thousands of dollars for residential and outpatient opioid treatment. The potential for significant profit is plainly illustrated by the influx of private equity firms, such as Bain Capital, that are investing heavily in treatment centers.
Reports of malfeasance and misconduct, by owners, operators, staff, and others connected with the industry are beginning to get the attention of authorities. There have been reports of outpatient treatment centers that spend lavishly on furnishing, on BMWs and signed art, yet are understaffed, leading to inadequate one-on-one counseling and even sexual transgressions between residents. There are centers that have been investigated for insurance fraud, such as illegally waiving a copay or a deductible or for charging up to $5,000 for a simple urine five drug screen, often multiple times a day. And there is evidence of “junkie hunters” who cruise for people with addictions and brokers who provide such people with fake addresses in order to qualify for insurance plans with excellent benefits for addiction treatment.
Probably the best means to find a suitable outpatient treatment center is by way of a local, experienced, and respected chemical dependency counselor or physician certified in addiction medicine. If people with substance use disorders and their families want to independently conduct a search, as a good rule of thumb, they should be advised to consider programs affiliated with major medical centers and hospitals or outpatient treatment centers that have been established in good standing for years, in contrast to the rash of pop-up, for-profit programs. Of equal, or even greater importance, is that the prospective center ought to be accredited by a national organization, for example, The Joint Commission, and its staff ought to be licensed and credentialed as well.
In addition, there is merit if the staff has been educated, trained, and supervised under the direction of a respected institution. Needless to add, an outpatient treatment center must use evidence-based practices as the bedrock of treatment; this includes pharmacotherapies such as Suboxone and naltrexone (Vivitrol), and behavioral therapies such as cognitive-behavioral therapy, contingency management, and motivational enhancement. To date, massage and essential oils might be relaxing and pleasurable, but they are not considered accepted standard of care.
It is crucial, too, that an outpatient treatment center have both the resources to reliably handle acute medical detox, which can be a potentially life-threatening emergency, and the medical personnel who can assess and treat such medical conditions as hypertension as well as psychiatric illnesses such as bipolar and generalized anxiety disorders. A prospective patient also should inquire whether any of the staff has been the subject of disciplinary action by a licensing board or whether the center has been investigated by the state or a national accrediting organization.
Because addiction so often has facets rooted in the family system, and recovery so often depends on family support, an outpatient treatment center should provide a structured family program integrated into the patient’s treatment and emphasize the importance of continued family involvement after discharge.
Lastly, the best treatment centers often regularly update a patient’s local therapist and physician, spell out the elements of successful aftercare (12-step programs, and so on), and provide amenities, such as calls to a recently discharged patient and an alumni support network.
Dr. Marseille is a psychiatrist who works on the staff of a clinic in Wheaton, Ill. His special interests include adolescent and addiction medicine, eating disorders, trauma, bipolar disorder, and the psychiatric manifestations of acute and chronic medical conditions.
This article was updated 12/15/17.
Roughly 6 months ago, a primary care physician referred a patient to our clinic for an assessment for opioid use disorder and a recommendation for treatment. The patient estimated, likely underestimated, his daily heroin use to five bags and dropped positive, in addition to heroin, for benzodiazepines, amphetamines, and cannabis. He was in a profession in which public safety was a critical concern, and he refused to notify his employer’s employee assistance program. He also declined to voluntarily admit himself for detox and treatment at the local, fully accredited addiction program, which was affiliated with a major university medical center. Instead, after an Internet search, the patient opted for an opioid treatment center featuring massage therapy, acupuncture, a stable, a sweat lodge – and a magnificent view of the Pacific Ocean.
Mental health professionals and lay people alike are aware of the “opioid crisis” – the derailment of lives, the devastation to communities, the death toll. But despite proposals to increase research funding, policies aimed at tightening the prescribing of opioids, and pledges to ramp up interdiction of heroin traffic, there is often an ignorance and confusion regarding the best, evidence-based approaches to getting patients with substance use disorders clean and keeping them clean.
Unfortunately, as with any crisis, there will be opportunists preying on vulnerable patients and their families. And this travesty has reportedly escalated, as outpatient treatment centers take advantage of laws guaranteeing mental health parity and insurance companies paying out tens of thousands of dollars for residential and outpatient opioid treatment. The potential for significant profit is plainly illustrated by the influx of private equity firms, such as Bain Capital, that are investing heavily in treatment centers.
Reports of malfeasance and misconduct, by owners, operators, staff, and others connected with the industry are beginning to get the attention of authorities. There have been reports of outpatient treatment centers that spend lavishly on furnishing, on BMWs and signed art, yet are understaffed, leading to inadequate one-on-one counseling and even sexual transgressions between residents. There are centers that have been investigated for insurance fraud, such as illegally waiving a copay or a deductible or for charging up to $5,000 for a simple urine five drug screen, often multiple times a day. And there is evidence of “junkie hunters” who cruise for people with addictions and brokers who provide such people with fake addresses in order to qualify for insurance plans with excellent benefits for addiction treatment.
Probably the best means to find a suitable outpatient treatment center is by way of a local, experienced, and respected chemical dependency counselor or physician certified in addiction medicine. If people with substance use disorders and their families want to independently conduct a search, as a good rule of thumb, they should be advised to consider programs affiliated with major medical centers and hospitals or outpatient treatment centers that have been established in good standing for years, in contrast to the rash of pop-up, for-profit programs. Of equal, or even greater importance, is that the prospective center ought to be accredited by a national organization, for example, The Joint Commission, and its staff ought to be licensed and credentialed as well.
In addition, there is merit if the staff has been educated, trained, and supervised under the direction of a respected institution. Needless to add, an outpatient treatment center must use evidence-based practices as the bedrock of treatment; this includes pharmacotherapies such as Suboxone and naltrexone (Vivitrol), and behavioral therapies such as cognitive-behavioral therapy, contingency management, and motivational enhancement. To date, massage and essential oils might be relaxing and pleasurable, but they are not considered accepted standard of care.
It is crucial, too, that an outpatient treatment center have both the resources to reliably handle acute medical detox, which can be a potentially life-threatening emergency, and the medical personnel who can assess and treat such medical conditions as hypertension as well as psychiatric illnesses such as bipolar and generalized anxiety disorders. A prospective patient also should inquire whether any of the staff has been the subject of disciplinary action by a licensing board or whether the center has been investigated by the state or a national accrediting organization.
Because addiction so often has facets rooted in the family system, and recovery so often depends on family support, an outpatient treatment center should provide a structured family program integrated into the patient’s treatment and emphasize the importance of continued family involvement after discharge.
Lastly, the best treatment centers often regularly update a patient’s local therapist and physician, spell out the elements of successful aftercare (12-step programs, and so on), and provide amenities, such as calls to a recently discharged patient and an alumni support network.
Dr. Marseille is a psychiatrist who works on the staff of a clinic in Wheaton, Ill. His special interests include adolescent and addiction medicine, eating disorders, trauma, bipolar disorder, and the psychiatric manifestations of acute and chronic medical conditions.
This article was updated 12/15/17.
Job Satisfaction
You know that good feeling you get when you think about what you do for a living? That’s job satisfaction. So, what contributes to that feeling? Why does it matter?
Job satisfaction among both NPs and PAs remains high since last year’s survey.
The major determinants of job satisfaction include autonomy, appropriate pay, having adequate time to interact with patients, collegial support, and opportunities for professional growth.1-3
Dissatisfaction—due, for example, to work-life imbalance, adverse working conditions, or threat of malpractice lawsuits—may motivate experienced clinicians to leave their jobs. Clearly, keeping NPs and PAs engaged and satisfied is key to creating and retaining effective health care teams, resulting in better patient care and lower health care costs.1,4
So, are you interested in discovering ways to increase your career satisfaction? Actively seeking a new position? Looking to hire or retain staff? Check out the PDF for information on pay, benefits, and reasons your peers leave their jobs—broken out by profession and by region.
You know that good feeling you get when you think about what you do for a living? That’s job satisfaction. So, what contributes to that feeling? Why does it matter?
Job satisfaction among both NPs and PAs remains high since last year’s survey.
The major determinants of job satisfaction include autonomy, appropriate pay, having adequate time to interact with patients, collegial support, and opportunities for professional growth.1-3
Dissatisfaction—due, for example, to work-life imbalance, adverse working conditions, or threat of malpractice lawsuits—may motivate experienced clinicians to leave their jobs. Clearly, keeping NPs and PAs engaged and satisfied is key to creating and retaining effective health care teams, resulting in better patient care and lower health care costs.1,4
So, are you interested in discovering ways to increase your career satisfaction? Actively seeking a new position? Looking to hire or retain staff? Check out the PDF for information on pay, benefits, and reasons your peers leave their jobs—broken out by profession and by region.
You know that good feeling you get when you think about what you do for a living? That’s job satisfaction. So, what contributes to that feeling? Why does it matter?
Job satisfaction among both NPs and PAs remains high since last year’s survey.
The major determinants of job satisfaction include autonomy, appropriate pay, having adequate time to interact with patients, collegial support, and opportunities for professional growth.1-3
Dissatisfaction—due, for example, to work-life imbalance, adverse working conditions, or threat of malpractice lawsuits—may motivate experienced clinicians to leave their jobs. Clearly, keeping NPs and PAs engaged and satisfied is key to creating and retaining effective health care teams, resulting in better patient care and lower health care costs.1,4
So, are you interested in discovering ways to increase your career satisfaction? Actively seeking a new position? Looking to hire or retain staff? Check out the PDF for information on pay, benefits, and reasons your peers leave their jobs—broken out by profession and by region.
RSS feeds are a versatile online tool
Recently I mentioned RSS news feeds as a useful, versatile online tool, but because it has been a while since I’ve discussed RSS feeds, an update is certainly in order.
The sheer volume of information on the web makes quick and efficient searching an indispensable skill, but once you have become quick and efficient at finding the information you need, a new problem arises: The information changes! All the good medical, news, and other information-based websites change and update their content on a regular, but unpredictable basis. And checking each one for new information can be very tedious, if you can remember to do it at all.
Many sites offer an e-mail service to notify you of new content, but multiple e-mail subscriptions clutter your inbox and often can’t select out the information you’re really interested in. RSS (which stands for “Rich Site Summary” or “Really Simple Syndication,” depending on whom you ask) is a file format, and websites use that format (or a similar one called Atom) to produce a summary file, or “feed,” of new content, along with links to full versions of that content. When you subscribe to a given website’s feed, you’ll receive a summary of new content each time the website is updated.
Thousands of websites now offer RSS feeds, including most of the large medical information services, all the major news organizations, and many web logs.
Many readers are free, but those with the most advanced features usually charge a fee of some sort. (As always, I have no financial interest in any enterprise discussed in this column.) A comprehensive and more or less up-to-date list of available readers can be found in the Wikipedia article “Comparison of feed aggregators.”
It’s not always easy to find out whether a particular website offers a feed, because there is no universally recognized method of indicating its existence. Look for a link to “RSS” or “Syndicate This,” or an orange rectangle with the letters “RSS,” or “XML” (don’t ask). These links are not always on the home page. You may need to consult the site map to find a link to a page explaining available feeds, and how to find them.
Some of the major sites have multiple feeds to choose from. For example, you can generate a feed of current stories related to the page that you are following on Google News by clicking the RSS link on any Google News page.
In addition to notifying you of important news headlines, changes to your favorite websites, and new developments in any medical (or other) field of interest to you, RSS feeds have many other uses. Some will notify you of new products in a store or catalog, new newsletter issues (including e-mail newsletters), weather and other changing-condition alerts, and the addition of new items to a database – or new members to a group.
It can work the other way as well: If you want readers of your website, blog, or podcast to receive the latest news about your practice, such as new treatments and procedures you’re offering – or if you want to know immediately anytime your name pops up in news or gossip sites – you can create your own RSS feed. Next month, I’ll explain exactly how to do that.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
Recently I mentioned RSS news feeds as a useful, versatile online tool, but because it has been a while since I’ve discussed RSS feeds, an update is certainly in order.
The sheer volume of information on the web makes quick and efficient searching an indispensable skill, but once you have become quick and efficient at finding the information you need, a new problem arises: The information changes! All the good medical, news, and other information-based websites change and update their content on a regular, but unpredictable basis. And checking each one for new information can be very tedious, if you can remember to do it at all.
Many sites offer an e-mail service to notify you of new content, but multiple e-mail subscriptions clutter your inbox and often can’t select out the information you’re really interested in. RSS (which stands for “Rich Site Summary” or “Really Simple Syndication,” depending on whom you ask) is a file format, and websites use that format (or a similar one called Atom) to produce a summary file, or “feed,” of new content, along with links to full versions of that content. When you subscribe to a given website’s feed, you’ll receive a summary of new content each time the website is updated.
Thousands of websites now offer RSS feeds, including most of the large medical information services, all the major news organizations, and many web logs.
Many readers are free, but those with the most advanced features usually charge a fee of some sort. (As always, I have no financial interest in any enterprise discussed in this column.) A comprehensive and more or less up-to-date list of available readers can be found in the Wikipedia article “Comparison of feed aggregators.”
It’s not always easy to find out whether a particular website offers a feed, because there is no universally recognized method of indicating its existence. Look for a link to “RSS” or “Syndicate This,” or an orange rectangle with the letters “RSS,” or “XML” (don’t ask). These links are not always on the home page. You may need to consult the site map to find a link to a page explaining available feeds, and how to find them.
Some of the major sites have multiple feeds to choose from. For example, you can generate a feed of current stories related to the page that you are following on Google News by clicking the RSS link on any Google News page.
In addition to notifying you of important news headlines, changes to your favorite websites, and new developments in any medical (or other) field of interest to you, RSS feeds have many other uses. Some will notify you of new products in a store or catalog, new newsletter issues (including e-mail newsletters), weather and other changing-condition alerts, and the addition of new items to a database – or new members to a group.
It can work the other way as well: If you want readers of your website, blog, or podcast to receive the latest news about your practice, such as new treatments and procedures you’re offering – or if you want to know immediately anytime your name pops up in news or gossip sites – you can create your own RSS feed. Next month, I’ll explain exactly how to do that.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
Recently I mentioned RSS news feeds as a useful, versatile online tool, but because it has been a while since I’ve discussed RSS feeds, an update is certainly in order.
The sheer volume of information on the web makes quick and efficient searching an indispensable skill, but once you have become quick and efficient at finding the information you need, a new problem arises: The information changes! All the good medical, news, and other information-based websites change and update their content on a regular, but unpredictable basis. And checking each one for new information can be very tedious, if you can remember to do it at all.
Many sites offer an e-mail service to notify you of new content, but multiple e-mail subscriptions clutter your inbox and often can’t select out the information you’re really interested in. RSS (which stands for “Rich Site Summary” or “Really Simple Syndication,” depending on whom you ask) is a file format, and websites use that format (or a similar one called Atom) to produce a summary file, or “feed,” of new content, along with links to full versions of that content. When you subscribe to a given website’s feed, you’ll receive a summary of new content each time the website is updated.
Thousands of websites now offer RSS feeds, including most of the large medical information services, all the major news organizations, and many web logs.
Many readers are free, but those with the most advanced features usually charge a fee of some sort. (As always, I have no financial interest in any enterprise discussed in this column.) A comprehensive and more or less up-to-date list of available readers can be found in the Wikipedia article “Comparison of feed aggregators.”
It’s not always easy to find out whether a particular website offers a feed, because there is no universally recognized method of indicating its existence. Look for a link to “RSS” or “Syndicate This,” or an orange rectangle with the letters “RSS,” or “XML” (don’t ask). These links are not always on the home page. You may need to consult the site map to find a link to a page explaining available feeds, and how to find them.
Some of the major sites have multiple feeds to choose from. For example, you can generate a feed of current stories related to the page that you are following on Google News by clicking the RSS link on any Google News page.
In addition to notifying you of important news headlines, changes to your favorite websites, and new developments in any medical (or other) field of interest to you, RSS feeds have many other uses. Some will notify you of new products in a store or catalog, new newsletter issues (including e-mail newsletters), weather and other changing-condition alerts, and the addition of new items to a database – or new members to a group.
It can work the other way as well: If you want readers of your website, blog, or podcast to receive the latest news about your practice, such as new treatments and procedures you’re offering – or if you want to know immediately anytime your name pops up in news or gossip sites – you can create your own RSS feed. Next month, I’ll explain exactly how to do that.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
AHRQ Practice Toolbox: Health Literacy
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
This is the fifth in a series of articles from the National Center for Excellence in Primary Care Research (NCEPCR) in the Agency for Healthcare Research and Quality (AHRQ). This series introduces sets of tools and resources designed to help your practice.
Members of primary care teams know that to be successful, they have to communicate effectively with patients and family members. Communication skills, however, are not emphasized in health professional schools. Furthermore, clear communication is important not only for clinicians, but for all members of primary care practices. In order to help patients be successful, practices also need to help patients navigate what is often a confusing health system with demands that frequently exceed patients’ abilities.
Health literacy universal precautions are aimed at the following three things:
- Simplifying communication with and confirming comprehension for all patients.
- Making the office environment and health care system easier to navigate.
- Supporting patients’ efforts to improve their health.
The AHRQ Health Literacy Universal Precautions Toolkit is designed for the busy adult or pediatric primary care practice. Each of its 21 tools is only 3-5 pages long, and a practice can jump in wherever it likes. The tools specify concrete action steps and link to other resources. A Quick Start Guide lets you watch a 6-minute video, then pick one of three tools to implement: Conduct Brown Bag Medicine Reviews, Communicate Clearly, or Use the Teach-Back Method. Practices that want to start the journey toward becoming a health literate organization can start with the first two tools: Form a Team and Create a Health Literate Improvement Plan, which includes a practice self-assessment. Practices can also choose focus their efforts on one of the four health literacy domains:
- Spoken Communication
- Written Communication
- Self-Management and Empowerment
- Supportive Systems
In addition to the Toolkit, AHRQ has created a companion guide with concrete advice based on the implementation experiences of diverse primary care practices. At least one person – such as a practice facilitator, quality improvement specialist, or health literacy team leader – should read it before you get started.
Adopting health literacy universal precautions can help you reach your practice’s goals, whether they are becoming a patient-centered medical home or preparing for value-based payment.
Links to health literacy resources:
AHRQ Health Literacy Universal Precautions Toolkit, 2nd edition: https://www.ahrq.gov/literacy
Guide to Implementing the Health Literacy Universal Precautions Toolkit: Practical Ideas for Primary Care Practices: https://www.ahrq.gov/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/impguide/index.html
Crosswalk between the tools included in the Toolkit and the PCMH certification standards (as of 2014) of the National Committee for Quality Assurance (NCQA), The Joint Commission, and the Utilization Review Accreditation Committee (URAC): https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/quality-resources/tools/literacy-toolkit/pcmh-crosswalk.pdf
Index of AHRQ Health Literacy Resources: https://www.ahrq.gov/professionals/clinicians-providers/resources/health-literacy.html
Diplomates of the American Board of Pediatrics and the American Board of Family Medicine can take health literacy modules (both knowledge self-assessment and performance improvement modules) for maintenance of certification.
Ms. Brach is Senior Health Care Researcher at AHRQ.
National Academy of Medicine should revisit issue of fetal alcohol exposure
More than 20 years ago the Institute of Medicine (recently renamed the National Academy of Medicine, or NAM) issued its landmark report on fetal alcohol syndrome. Since then, there has been an explosion of research on the issue of fetal alcohol exposure – and NAM needs to revisit the issue and release another report.
Unfortunately, too few physicians and not enough people in the larger society understand public health and that the health status of the unfortunate among us affects the health status of the most fortunate of us. In short, low-income people are the proverbial “canary in the coal mine.”
Accordingly, solving the health care problems of low-income people would solve the health care problems of the middle and upper class. Consider where the United States would be had we paid attention to the opioid epidemic in low-income communities instead of waiting until it spread into everyone’s “safe” communities. We would have tried and tested solutions to the problem as it currently exists.
Another reason NAM needs to revisit FASD – currently proposed to be called neurobehavioral disorders associated with prenatal alcohol exposure in the DSM-5 – are the new findings that link FASD to seizure disorders and other neurodevelopmental disorders of childhood, such as intellectual disability, attention-deficit/hyperactivity disorder, speech and language disorders, motor disorders, specific learning disorders, and autism. In fact, new research is emerging from Robert Freedman, MD, and his team at the University of Colorado Denver, to suggest that preventing choline deficiency in pregnancy (the mechanism producing neurodevelopmental defects in FASD) may not only prevent neurodevelopmental disorders of childhood but also schizophrenia. Further, it has become abundantly clear that choline deficiency (often generated by FASD), is responsible for affect dysregulation, which is a common thread in various forms of violence and suicide.
A recent report highlighted the findings that inmates incarcerated in Mexican prisons have high rates of intellectual disability, and we know that FASD is one of the leading causes of this problem, but we are not screening for it in our juvenile detention centers, jails, or prisons. Consequently, we need to look for the prevalence of FASD in special education as well as in foster care, because these services often feed our correctional institutions. There also is some recent animal evidence suggesting that sufficient prenatal choline during pregnancy may be protective against Alzheimer’s disease – soon to be an even greater public problem in the United States. Lastly, the neuroscience findings regarding FASD also are emerging.
Hence, there is substantial information growing in various, different but overlapping areas of our systems addressing the nation’s public health and well-being. One of the most respected sources of credible science in America is the National Academy Science. The NAM should convene a meeting of the experts to examine the current state of FASD knowledge. If there is sufficient new information, the NAM needs to develop a new report on FASD. It has been 21 years since the first FAS report from the Institute of Medicine and it needs to be revisited. But it appears that the correctional, child protective services, special education, and mental health fields are not aware of the breadth of available research and its importance to the nation’s public health. Determining how fetal alcohol exposure/choline deficiency affects children and adults in special education, foster care, juvenile and adult corrections systems – along with such other social issues as prematurity, disability, unemployment, homelessness, suicide, violence, and mental health – is critical to our nation’s future.
Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.
More than 20 years ago the Institute of Medicine (recently renamed the National Academy of Medicine, or NAM) issued its landmark report on fetal alcohol syndrome. Since then, there has been an explosion of research on the issue of fetal alcohol exposure – and NAM needs to revisit the issue and release another report.
Unfortunately, too few physicians and not enough people in the larger society understand public health and that the health status of the unfortunate among us affects the health status of the most fortunate of us. In short, low-income people are the proverbial “canary in the coal mine.”
Accordingly, solving the health care problems of low-income people would solve the health care problems of the middle and upper class. Consider where the United States would be had we paid attention to the opioid epidemic in low-income communities instead of waiting until it spread into everyone’s “safe” communities. We would have tried and tested solutions to the problem as it currently exists.
Another reason NAM needs to revisit FASD – currently proposed to be called neurobehavioral disorders associated with prenatal alcohol exposure in the DSM-5 – are the new findings that link FASD to seizure disorders and other neurodevelopmental disorders of childhood, such as intellectual disability, attention-deficit/hyperactivity disorder, speech and language disorders, motor disorders, specific learning disorders, and autism. In fact, new research is emerging from Robert Freedman, MD, and his team at the University of Colorado Denver, to suggest that preventing choline deficiency in pregnancy (the mechanism producing neurodevelopmental defects in FASD) may not only prevent neurodevelopmental disorders of childhood but also schizophrenia. Further, it has become abundantly clear that choline deficiency (often generated by FASD), is responsible for affect dysregulation, which is a common thread in various forms of violence and suicide.
A recent report highlighted the findings that inmates incarcerated in Mexican prisons have high rates of intellectual disability, and we know that FASD is one of the leading causes of this problem, but we are not screening for it in our juvenile detention centers, jails, or prisons. Consequently, we need to look for the prevalence of FASD in special education as well as in foster care, because these services often feed our correctional institutions. There also is some recent animal evidence suggesting that sufficient prenatal choline during pregnancy may be protective against Alzheimer’s disease – soon to be an even greater public problem in the United States. Lastly, the neuroscience findings regarding FASD also are emerging.
Hence, there is substantial information growing in various, different but overlapping areas of our systems addressing the nation’s public health and well-being. One of the most respected sources of credible science in America is the National Academy Science. The NAM should convene a meeting of the experts to examine the current state of FASD knowledge. If there is sufficient new information, the NAM needs to develop a new report on FASD. It has been 21 years since the first FAS report from the Institute of Medicine and it needs to be revisited. But it appears that the correctional, child protective services, special education, and mental health fields are not aware of the breadth of available research and its importance to the nation’s public health. Determining how fetal alcohol exposure/choline deficiency affects children and adults in special education, foster care, juvenile and adult corrections systems – along with such other social issues as prematurity, disability, unemployment, homelessness, suicide, violence, and mental health – is critical to our nation’s future.
Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.
More than 20 years ago the Institute of Medicine (recently renamed the National Academy of Medicine, or NAM) issued its landmark report on fetal alcohol syndrome. Since then, there has been an explosion of research on the issue of fetal alcohol exposure – and NAM needs to revisit the issue and release another report.
Unfortunately, too few physicians and not enough people in the larger society understand public health and that the health status of the unfortunate among us affects the health status of the most fortunate of us. In short, low-income people are the proverbial “canary in the coal mine.”
Accordingly, solving the health care problems of low-income people would solve the health care problems of the middle and upper class. Consider where the United States would be had we paid attention to the opioid epidemic in low-income communities instead of waiting until it spread into everyone’s “safe” communities. We would have tried and tested solutions to the problem as it currently exists.
Another reason NAM needs to revisit FASD – currently proposed to be called neurobehavioral disorders associated with prenatal alcohol exposure in the DSM-5 – are the new findings that link FASD to seizure disorders and other neurodevelopmental disorders of childhood, such as intellectual disability, attention-deficit/hyperactivity disorder, speech and language disorders, motor disorders, specific learning disorders, and autism. In fact, new research is emerging from Robert Freedman, MD, and his team at the University of Colorado Denver, to suggest that preventing choline deficiency in pregnancy (the mechanism producing neurodevelopmental defects in FASD) may not only prevent neurodevelopmental disorders of childhood but also schizophrenia. Further, it has become abundantly clear that choline deficiency (often generated by FASD), is responsible for affect dysregulation, which is a common thread in various forms of violence and suicide.
A recent report highlighted the findings that inmates incarcerated in Mexican prisons have high rates of intellectual disability, and we know that FASD is one of the leading causes of this problem, but we are not screening for it in our juvenile detention centers, jails, or prisons. Consequently, we need to look for the prevalence of FASD in special education as well as in foster care, because these services often feed our correctional institutions. There also is some recent animal evidence suggesting that sufficient prenatal choline during pregnancy may be protective against Alzheimer’s disease – soon to be an even greater public problem in the United States. Lastly, the neuroscience findings regarding FASD also are emerging.
Hence, there is substantial information growing in various, different but overlapping areas of our systems addressing the nation’s public health and well-being. One of the most respected sources of credible science in America is the National Academy Science. The NAM should convene a meeting of the experts to examine the current state of FASD knowledge. If there is sufficient new information, the NAM needs to develop a new report on FASD. It has been 21 years since the first FAS report from the Institute of Medicine and it needs to be revisited. But it appears that the correctional, child protective services, special education, and mental health fields are not aware of the breadth of available research and its importance to the nation’s public health. Determining how fetal alcohol exposure/choline deficiency affects children and adults in special education, foster care, juvenile and adult corrections systems – along with such other social issues as prematurity, disability, unemployment, homelessness, suicide, violence, and mental health – is critical to our nation’s future.
Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.
Urinary tract agents: A safety review in pregnancy
The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.
The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.
Analgesics
The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.
There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
Antispasmodics
The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.
These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.
In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
Urinary acidifiers
Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.
Urinary alkalinizers
Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.
Urinary germicides
There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.
The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.
The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).
Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
Breastfeeding
Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.
Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.
Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.
The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.
Analgesics
The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.
There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
Antispasmodics
The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.
These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.
In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
Urinary acidifiers
Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.
Urinary alkalinizers
Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.
Urinary germicides
There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.
The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.
The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).
Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
Breastfeeding
Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.
Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.
Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
The reported frequency of use in pregnancy and during breastfeeding for most of these agents is very low or completely absent.
The five subclasses of urinary tract agents are analgesics, antispasmodics, urinary acidifiers, urinary alkalinizers, and urinary germicides. With the exception of the three urinary germicides, anti-infectives are not covered in this column.
Analgesics
The analgesic subclass includes pentosan and phenazopyridine. Pentosan (Elmiron), a heparinlike compound, is an oral drug that is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. Systemic absorption is low, at about 6%. Because of the high molecular weight (4,000-6,000), it does not appear to cross the placenta, at least in the first half of pregnancy. A 1975 reference described its use in five women with preeclampsia. Each patient received 100 mg intramuscularly every 8 hours for about 5 days in the last weeks of pregnancy. No maternal benefit from the therapy was observed. There was apparently no fetal harm, but the neonatal outcomes were not described.
There are substantial – more than 900 – human pregnancy exposures in the first trimester with phenazopyridine. The exposures were not related to an increased risk of embryo-fetal harm and so use of the drug in pregnancy can be classified as compatible. However, the low molecular weight (about 214 for the free base) suggests that the drug will cross to the embryo and fetus.
Antispasmodics
The eight antispasmodics are darifenacin (Enablex), fesoterodine (Toviaz), flavoxate, mirabegron (Myrbetriq), oxybutynin (Ditropan XL), solifenacin (Vesicare), tolterodine (Detrol LA), and trospium.
These agents are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The molecular weights range between 342 and 508, suggesting that all will cross the human placenta. There are no human pregnancy data for six of these agents and very limited data for flavoxate and oxybutynin. There is no evidence of embryo-fetal harm from these two drugs, but only one case involved exposure in the first trimester.
In seven of these drugs, the animal data suggested low risk. There was no embryo harm from doses that were equal to or less than 10 times the human dose based on body surface area (BSA) or area under the concentration curve (AUC). Solifenacin did cause embryo toxicity in pregnant mice. There was no embryo toxicity in pregnant rats and rabbits, but the maximum doses used were very low. Overall, the available data suggest that exposure to an antispasmodic in pregnancy is low risk for embryo, fetal, and newborn harm.
Urinary acidifiers
Ammonium chloride is a urinary acidifier as well as a respiratory expectorant. There is a large amount of data related to when the drug was used as an expectorant. There was no evidence that this use was associated with large categories of major or minor malformations. However, there were possible associations with three individual defects: inguinal hernia, cataract, and any benign tumor. No reports describing its use as a urinary acidifier have been located. When large amounts are consumed near term, the drug may cause acidosis in the mother and fetus. The molecular weight (about 53) suggests that it will cross the placenta.
Urinary alkalinizers
Potassium citrate (Urocit-K) is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate with nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. The molecular weight (about 307) suggests it will cross the placenta. Only one case of its use in pregnancy has been located. The newborn had an unspecified defect but no other information was provided. The animal data in four species suggest low risk.
Urinary germicides
There are three urinary germicides: methenamine, methylene blue, and nitrofurantoin. Methenamine is available as methenamine mandelate (molecular weight abut 292) and methenamine hippurate (molecular weight about 319). Both are metabolized to formaldehyde (molecular weight about 30), the active agent. The molecular weights suggest that all will cross the placenta. The use of methenamine during pregnancy has been reported in more than 750 pregnancies. There have been no embryo or fetal adverse effects attributed to the drug.
The human data involving oral methylene blue, a weak urinary germicide, is limited to 55 exposures. There were three infants with birth defects (type not specified). Several reports have described the use of intra-amniotic injections to assist in the diagnosis of suspected membrane rupture. This use has resulted in newborns with hemolytic anemia, hyperbilirubinemia with or without Heinz body formation, blue staining of the skin, and methemoglobinemia. Fetal deaths have also been described. Recommendations to avoid the intra-amniotic use of methylene blue were issued more than 10 years ago. Moreover, the use of oral methylene blue as a urinary germicide is no longer recommended.
The low molecular weight (about 238) of nitrofurantoin suggests that it will cross the placenta. It is commonly used in pregnancy for the treatment or prophylaxis of urinary tract infections. The large amount of human data indicates that the risk of drug-induced birth defects is low. Several cohort studies have found no increased risk for birth defects. However, some case-control studies have found increased risks for hypoplastic left heart syndrome and oral clefts. A 2015 review concluded that this difference was due to the increased sensitivity of case-control studies to detect adverse effects (J Obstet Gynaecol Can. 2015 Feb;37[2]:150-6).
Use of the drug close to term may cause hemolytic anemia in newborns who are glucose-6-phosphate dehydrogenase (G6PD) deficient. Although rare, this may also occur in newborns who are not G6PD deficient. The best course is to avoid use of the drug close to delivery. As for use of the drug in the first trimester, ACOG’s Committee on Obstetric Practice stated in Committee Opinion No. 717 that nitrofurantoin was still thought to be appropriate when no other suitable alternative antibiotics were available (Obstet Gynecol. 2017 Sept;130[3]:666-7).
Breastfeeding
Except for methenamine and nitrofurantoin, there are no data related to the use of the urinary tract drugs during breastfeeding. Peak levels of methenamine occur at 1 hour, but no reports of adverse effects on nursing infants have been located. Several reports have described the use of nitrofurantoin during breastfeeding. Minor diarrhea was noted in two infants. However, breastfeeding an infant with G6PD deficiency could lead to hemolytic anemia.
Phenazopyridine should be used with caution especially for an infant younger than 1 month or with G6PD deficiency because of the risk for methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia.
Although there have been no reports of the use of mirabegron during lactation, the characteristics of the drug – low molecular weight (about 397), long elimination half life (50 hours), and moderate plasma protein binding (about 71%) – suggest that the drug will be excreted into milk, potentially in clinically significant amounts. There is also concern with use of tolterodine (molecular weight about 476) because both the primary drug and its equipotent metabolite may be excreted into milk.
Mr. Briggs is a clinical professor of pharmacy at the University of California, San Francisco, and an adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
¿No hablás español? Help Is Here
According to the 2015 US Census Bureau, more than 60 million individuals—about 19% of Americans—reported speaking a language other than English at home, and more than 25 million reported their English-speaking ability as less than “very well.” The top five non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers. 1,2
In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may be a reasonable alternative.
THREE TYPES OF TRANSLATOR APPS
Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.
Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less practical, but they can help providers find and define specific terms in a given language.
General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.
Recommended apps
My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores, to aid clinicians in using such apps during clinical encounters with non-English speakers.3
The top recommended translator apps are listed in the table, evaluated with criteria from a shortened version of the APPLICATIONS scoring system: app comprehensiveness, price, platform, literature use, and important special features.4 We hope these tools will help you enhance communication with your patients who have limited English proficiency.
1. United States Census Bureau. Detailed language spoken at home and ability to speak English for the population 5 years and over: 2009–2013. www.census.gov/data/tables/2013/demo/2009-2013-lang-tables.html. Accessed November 1, 2017.
2. United States Census Bureau. U.S. and world population clock. www.census.gov/popclock/?intcmp=home_pop. Accessed November 1, 2017.
3. Khander A, Farag S, Chen KT. Identification and rating of medical translator mobile applications using the APPLICATIONS scoring system [abstract 321]. Obstet Gynecol. 2017;129(5 suppl):101S.
4. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125(6):1478-1483.
According to the 2015 US Census Bureau, more than 60 million individuals—about 19% of Americans—reported speaking a language other than English at home, and more than 25 million reported their English-speaking ability as less than “very well.” The top five non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers. 1,2
In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may be a reasonable alternative.
THREE TYPES OF TRANSLATOR APPS
Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.
Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less practical, but they can help providers find and define specific terms in a given language.
General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.
Recommended apps
My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores, to aid clinicians in using such apps during clinical encounters with non-English speakers.3
The top recommended translator apps are listed in the table, evaluated with criteria from a shortened version of the APPLICATIONS scoring system: app comprehensiveness, price, platform, literature use, and important special features.4 We hope these tools will help you enhance communication with your patients who have limited English proficiency.
According to the 2015 US Census Bureau, more than 60 million individuals—about 19% of Americans—reported speaking a language other than English at home, and more than 25 million reported their English-speaking ability as less than “very well.” The top five non-English languages spoken at home were Spanish, French, Chinese, Tagalog, and Vietnamese, encompassing 72% of non-English speakers. 1,2
In the health care sector, translator services are essential for providing accurate and culturally competent care. Current options for translator services include face-to-face interpreters, phone-based translator services, and translator apps on mobile devices. In settings where face-to-face interpreters or phone-based translator services are not available, translator apps may be a reasonable alternative.
THREE TYPES OF TRANSLATOR APPS
Preset medical phrase translator apps require the user to search for or find a question or statement in order to facilitate a conversation. With these types of apps, a health care provider can choose fully conjugated sentences, which then can be played or read back to the patient in the chosen translated language. Within this group of apps, Canopy Speak and Universal Doctor Speaker are highly accessible, since both apps are available from the Apple iTunes and Google Play stores and both are free.
Medical dictionary apps require the user to search for a medical term in one language to receive a translation in another language. These apps are less practical, but they can help providers find and define specific terms in a given language.
General language translator apps require the user to enter a term, statement, or question in one language and then provide a translation in another language. Google Translate and Vocre Translate are examples.
Recommended apps
My colleagues, Dr. Amrin Khander and Dr. Sara Farag, and I identified and evaluated medical translator apps that are available from the Apple iTunes and Google Play stores, to aid clinicians in using such apps during clinical encounters with non-English speakers.3
The top recommended translator apps are listed in the table, evaluated with criteria from a shortened version of the APPLICATIONS scoring system: app comprehensiveness, price, platform, literature use, and important special features.4 We hope these tools will help you enhance communication with your patients who have limited English proficiency.
1. United States Census Bureau. Detailed language spoken at home and ability to speak English for the population 5 years and over: 2009–2013. www.census.gov/data/tables/2013/demo/2009-2013-lang-tables.html. Accessed November 1, 2017.
2. United States Census Bureau. U.S. and world population clock. www.census.gov/popclock/?intcmp=home_pop. Accessed November 1, 2017.
3. Khander A, Farag S, Chen KT. Identification and rating of medical translator mobile applications using the APPLICATIONS scoring system [abstract 321]. Obstet Gynecol. 2017;129(5 suppl):101S.
4. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125(6):1478-1483.
1. United States Census Bureau. Detailed language spoken at home and ability to speak English for the population 5 years and over: 2009–2013. www.census.gov/data/tables/2013/demo/2009-2013-lang-tables.html. Accessed November 1, 2017.
2. United States Census Bureau. U.S. and world population clock. www.census.gov/popclock/?intcmp=home_pop. Accessed November 1, 2017.
3. Khander A, Farag S, Chen KT. Identification and rating of medical translator mobile applications using the APPLICATIONS scoring system [abstract 321]. Obstet Gynecol. 2017;129(5 suppl):101S.
4. Chyjek K, Farag S, Chen KT. Rating pregnancy wheel applications using the APPLICATIONS scoring system. Obstet Gynecol. 2015;125(6):1478-1483.
Edaravone: Costs versus benefits
On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.
Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.
The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.
To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.
The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.
On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.
Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.
The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.
To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.
The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.
On May 5, 2017, the Food and Drug Administration approved edaravone (Radicava) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Developed by Mitsubishi Tanabe Pharma Corporation, edaravone is the first FDA-approved treatment for ALS since the approval of riluzole (Rilutek) in 1995. Edaravone was originally developed as an acute stroke treatment and then later studied in two separate trials in Japan to assess its efficacy in treating ALS.
Edaravone is administered intravenously and the standard dose of 60 mg takes about 1 hour to complete. The initial treatment cycle consists of once-daily dosing for 2 weeks, followed by a 2-week drug-free period. After the initial cycle, subsequent cycles consist of once-daily dosing for 10 days out of the next 2 weeks, followed by a 2-week drug-free period. The question of how long patients should take edaravone has not been resolved. The FDA did not define a limit to the duration of treatment. Some insurance companies have limited authorization to 6 months as that was the duration of treatment that showed benefit in the study. However, an open-label, 24-week extension of the second study showed that the change in ALSFRS-R was linear throughout the study. This suggests that the treatment benefit in patients with short duration of illness may continue for an additional 24 weeks. Thus, patients who have duration of illness of less than 2 years at presentation may benefit from 12 months of treatment.
The rigorous treatment schedule and IV administration of edaravone create additional concerns for ALS patients. Many patients will need to have a port placed. Patients with impaired mobility will need assistance with transportation to an infusion center. The time involved with taking all of these IV infusions will be considerable. Our experience at the Mayo Clinic reflects differing patient opinions. Some ALS patients with short duration of illness who clearly meet the criteria are not willing to commit to this form of therapy even if insurance will cover it. In contrast, some patients with advanced disease who do not meet the eligibility criteria have expressed the wish to try it.
To have access to edaravone in the United States, ALS patients must first complete an enrollment form and register with a Mitsubishi Tanabe subsidiary called Searchlight. Searchlight creates a Searchlight patient ID and conducts a benefit investigation to determine if the patient’s insurance will cover edaravone treatment. If the patient’s insurance approves edaravone, arrangements are made to ship the drug to the site or company that will perform the infusions. Insurance companies have taken different approaches to the approval of edaravone for ALS patients. Some insurers require that the patient meets the eligibility requirements of the Japanese study that showed benefit (duration of illness less than 2 years from symptom onset and forced vital capacity of at least 80% predicted). These strict criteria will exclude many patients. Other insurers have required only the diagnosis of ALS and the physician’s order. The cost of edaravone is estimated to be around $145,500 per year. The actual out-of-pocket cost to patients will vary depending on their specific insurance plans. In-home infusion of edaravone is another option patients can consider. Patients can pay the separate charges for in-home infusion if their insurance plans do not cover this.
The costs of edaravone are substantial. Beyond the expenses for the medication and infusion services, the patient faces the burden of committing time to frequent IV infusions and potential complications associated with having a port placed. Many ALS patients have decided against pursuing edaravone, suggesting that the perceived costs exceed the perceived benefits. Many ALS patients have started edaravone treatment with the belief that slowing of progression is worth the costs. It is too soon to know if those who have started edaravone will remain committed to the treatment for 6-12 months. Despite the differing approaches to edaravone treatment, it can be agreed upon that it is good to have a new treatment for ALS and that we must continue working to find therapies effective in substantially slowing or stopping the progression of ALS.
Ms. Chang is a research intern, and Dr. Ross is a professor of neurology and director of the ALS Clinic, at Mayo Clinic Arizona in Scottsdale. Dr. Ross reported serving as the Mayo Clinic Arizona site primary investigator for the ALS investigational drug NP001.
Physician health programs: ‘Diagnosing for dollars’?
As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.
Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.
More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”
Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.
“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”
Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.
The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”
PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).
As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.
Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.
More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”
Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.
“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”
Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.
The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”
PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).
As medicine struggles with rising rates of physician burnout, dissatisfaction, depression, and suicide, one solution comes in the form of Physician Health Programs, or PHPs. These organizations were originally started by volunteer physicians, often doctors in recovery, and funded by medical societies, as a way of providing help while maintaining confidentiality. Now, they are run by independent corporations, by medical societies in some states, and sometimes by hospitals or health systems. The services they offer vary by PHP, and they may have relationships with state licensing boards. While they can provide a gateway to help for a troubled doctor, there has also been concern about the services that are being provided.
Louise Andrew, MD, JD, served as the liaison from the American College of Emergency Physicians (ACEP) to the the Federation of State Medical Boards from 2006 to 2014. In an online forum called Collective Wisdom, Andrew talked about the benefits of Physician Health Programs as entities that are helpful to stuggling doctors and urged her colleagues to use them as a safe alternative to suffering in silence.
More recently, Dr. Andrew has become concerned that PHPs may have taken on the role of what is more akin to “diagnosing for dollars.” In her May, 2016 column in Emergency Physician’s Monthly, Andrew noted, “A decade later, and my convictions have changed dramatically. Horror stories that colleagues related to me while I chaired ACEP’s Personal and Professional WellBeing Committee cannot all be isolated events. For example, physicians who self-referred to the PHP for management of stress and depression were reportedly railroaded into incredibly expensive and inconvenient out-of-state drug and alcohol treatment programs, even when there was no coexisting drug or alcohol problem.”
Dr. Andrew is not the only one voicing concerns about PHPs. In “Physician Health Programs: More harm than good?” (Medscape, Aug. 19, 2015), Pauline Anderson wrote about a several problems that have surfaced. In North Carolina, the state audited the PHPs after complaints that they were mandating physicians to lengthy and expensive inpatient programs. The complaints asserted that the physicians had no recourse and were not able to see their records. “The state auditor’s report found no abuse by North Carolina’s PHP. However, there was a caveat – the report determined that abuse could occur and potentially go undetected.
“It also found that the North Carolina PHP created the appearance of conflicts of interest by allowing the centers to provide both patient evaluation and treatments and that procedures did not ensure that physicians receive quality evaluations and treatment because the PHP had no documented criteria for selecting treatment centers and did not adequately monitor them.”
Finally, in a Florida Fox4News story, “Are FL doctors and nurses being sent to rehab unnecessarily? Accusations: Overdiagnosing; overcharging” (Nov. 16, 2017), reporters Katie Lagrone and Matthew Apthorp wrote about financial incentives for evaluators to refer doctors to inpatient substance abuse facilities.
The American Psychiatric Association has made it a priority to address physician burnout and mental health. Richard F. Summers, MD, APA Trustee-at-Large noted: “State PHPs are an essential resource for physicians, but there is a tremendous diversity in quality and approach. It is critical that these programs include attention to mental health problems as well as addiction, and that they support individual physicians’ treatment and journey toward well-being. They need to be accessible, private, and high quality, and they should be staffed by excellent psychiatrists and other mental health professionals.”
PHPs provide a much-needed and wanted service. But if the goal is to provide mental health and substance abuse services to physicians who are struggling – to prevent physicians from burning out, leaving medicine, and dying of suicide – then any whiff of corruption and any fear of professional repercussions become a reason not to use these services. If they are to be helpful, physicians must feel safe using them.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016).
Myth of the Month: MONA for acute treatment of chest pain?
A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.
Which of these treatments do you recommend?
A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).
B. Oxygen, morphine, ASA.
C. ASA.
In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.
There is controversy over the safety of routine morphine use for patients with chest pain.
Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.1 Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.2 Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.3
Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).4 They found no increase in in-hospital complications or 1-year mortality.
The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.5,6
It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.7
The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.
In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).8 They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.
Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.9
Where does all this leave us in the treatment of suspected MI?
Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Am Heart J. 2005 Jun;149(6):1043-9.
2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.
3. Clin Res Cardiol. 2015 Sep;104(9):727-34.
4. Eur Heart J. 2016 Apr 1;37(13):1063-71.
5. BMJ. 1900 Dec 1;2(2083):1568.
6. JAMA. 1930 May 3;94(18):1363-5.
7. Br Med J. 1976 May 8;1(6018):1121-3.
8. Circulation. 2015 Jun 16;131(24):2143-50.
9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.
10. N Engl J Med. 2017 Sep 28;377(13):1240-9.
A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.
Which of these treatments do you recommend?
A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).
B. Oxygen, morphine, ASA.
C. ASA.
In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.
There is controversy over the safety of routine morphine use for patients with chest pain.
Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.1 Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.2 Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.3
Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).4 They found no increase in in-hospital complications or 1-year mortality.
The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.5,6
It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.7
The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.
In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).8 They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.
Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.9
Where does all this leave us in the treatment of suspected MI?
Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Am Heart J. 2005 Jun;149(6):1043-9.
2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.
3. Clin Res Cardiol. 2015 Sep;104(9):727-34.
4. Eur Heart J. 2016 Apr 1;37(13):1063-71.
5. BMJ. 1900 Dec 1;2(2083):1568.
6. JAMA. 1930 May 3;94(18):1363-5.
7. Br Med J. 1976 May 8;1(6018):1121-3.
8. Circulation. 2015 Jun 16;131(24):2143-50.
9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.
10. N Engl J Med. 2017 Sep 28;377(13):1240-9.
A 66-year-old man presents with substernal chest pressure and dyspnea that has been present for 45 minutes. He has nausea. Vital signs: blood pressure, 110/60; pulse, 100; oxygen saturation, 92%. Neck: elevated jugular venous pressure. Chest: clear. Cardiac: normal S1 S2, no murmurs. ECG: ST elevation in 2, 3, and aVF leads.
Which of these treatments do you recommend?
A. Morphine, oxygen, nitroglycerin, and aspirin (ASA).
B. Oxygen, morphine, ASA.
C. ASA.
In this patient, I think the correct approach would be to just give aspirin. Nitroglycerin would be problematic, as it appears that this patient might be having a right ventricular infarct, and lowering right-sided filling pressures with nitroglycerin may lead to severe hypotension.
There is controversy over the safety of routine morphine use for patients with chest pain.
Trip J. Meine, MD, and colleagues found that use of morphine either alone or in combination with nitroglycerin for patients presenting with non–ST-elevation acute coronary syndrome (NSTE-ACS) was associated with higher mortality.1 Cian P. McCarthy, MD, and colleagues found the same results, with morphine use associated with larger infarct size, a longer hospital stay, and a trend toward increased mortality in invasively managed NSTE-ACS patients.2 Suzanne de Waha and colleagues found that morphine use in patients with ST-segment elevation MIs had larger infarct size and less reperfusion success, as measured by cardiac MRI.3
Not all recent studies show a detrimental effect of morphine. Etienne Puymirat et al. reviewed in-hospital complications (death, nonfatal re-MI, stroke, stent thrombosis, and bleeding) and 1-year survival according to prehospital morphine use in 2,438 ST-elevation MI (STEMI) patients from the French Registry of Acute ST-elevation and non–ST-elevation Myocardial Infarction (FAST-MI).4 They found no increase in in-hospital complications or 1-year mortality.
The practice of using supplemental oxygen to treat all patients with MI became standard nearly a century ago, after oxygen was found in 1900 to relieve angina, and led to clinical improvement in four MI patients in a 1930 case series.5,6
It was not studied in a controlled trial until 1976, when J.M. Rawles, MD, and colleagues randomized 157 patients with MI to 24 hours of oxygen at 8 L/min or to ambient air. They found no difference in mortality between the groups, but they did find a higher burden of MI in the intervention arm receiving supplemental oxygen, as measured by mean serum aspartate aminotransferase levels.7
The topic was not addressed again in a significant randomized trial until this century. Most notably, two recent studies again demonstrated no benefit of supplemental oxygen in normoxemic patients with MI.
In the AVOID trial in 2015, Dion Stub, MD, PhD, and colleagues randomized 441 patients with STEMI to oxygen at 8 L/min – from diagnosis in an ambulance until after cardiac catheterization – or to ambient air. They found no difference in death at 6 months, but did find an increased rate of in-hospital recurrent MIs, with 0.9% of the control group and 5.5% of the oxygen intervention arm suffering recurrence (P = .006).8 They also showed a larger area of myocardial infarct in the oxygen group, as measured by peak creatine kinase levels and cardiac MRI at 6 months.
Proposed mechanisms of increased myocardial injury from hyperoxia include increased coronary vascular resistance resulting in decreased myocardial perfusion, and increased reperfusion injury from formation of free radicals.9
Where does all this leave us in the treatment of suspected MI?
Morphine should only be used when the patient has pain, and is probably best reserved for severe pain, as the safety of its use is not clear. While hypoxemia is a common consequence of MI – and may correlate with worse outcomes – treatment with supplemental oxygen in the absence of hypoxemia is not supported by current evidence, and may carry risk of harm. Nitroglycerin should be avoided in patients with right ventricular infarcts, and in patients who present with hypotension.
Dr. Tubbesing is a senior resident in medicine at the University of Washington, Seattle. Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].
References
1. Am Heart J. 2005 Jun;149(6):1043-9.
2. J Interv Cardiol. 2017 Nov 22. doi: 10.1111/joic.12464.
3. Clin Res Cardiol. 2015 Sep;104(9):727-34.
4. Eur Heart J. 2016 Apr 1;37(13):1063-71.
5. BMJ. 1900 Dec 1;2(2083):1568.
6. JAMA. 1930 May 3;94(18):1363-5.
7. Br Med J. 1976 May 8;1(6018):1121-3.
8. Circulation. 2015 Jun 16;131(24):2143-50.
9. Cochrane Database Syst Rev. 2016 Dec 19;12:CD007160.
10. N Engl J Med. 2017 Sep 28;377(13):1240-9.
