Rheumatology News

NEW YORK – An algorithm in development for psoriatic arthritis (PsA) is showing promise for directing patients to the biologic with the greatest likelihood of producing disease control, according to a proof-of-concept study presented at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Our technique involves a more precise functional assay showing exact T-cell behavior, compared to the previous assessments that only analyzed cellular phenotypes,” reported Gizem Ayan, MD, a fellow in rheumatology at Hacettepe University Faculty of Medicine, Ankara, Turkey.

Ted Bosworth/MDedge News

The concept of precision medicine in PsA as well as other autoimmune diseases is not new. Phenotypes and biomarkers have already shown potential for guiding treatment, according to Dr. Ayan, but she said none are yet guideline recommended or proven to improve patient outcomes.

The principle of the new algorithm that she and her coinvestigators are pursing is based on immunophenotype analysis conducted with a flow-cytometric cytokine secretion assay (FCCSA). In the protocol, monocytes obtained from peripheral blood undergo activation before an FCCSA to distinguish patients by their T-cell behavior.

The treatment decision tree is based on median ratios of tumor necrosis factor (TNF)-alpha, interleukin (IL)–22, IL-17, and interferon-gamma expression among CD4+ and CD8+ cells. Based on a yes-or-no response to specific immune patterns, the patient is funneled to a biologic that inhibits a dominant cytokine.

The proof-of-concept study, which enrolled 8 patients with PsA who were naive to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and 11 patients with PsA who were naive to biologic DMARDs (bDMARDs), was designed to demonstrate feasibility. It did not test clinical benefit, but it did show that immunophenotyping with this methodology can be performed efficiently.

“From the time a blood sample is obtained, the method provided results within 24 hours,” according to Dr. Ayan, who is now planning a randomized trial to test the ability of the algorithm to improve clinical outcomes.

In the decision tree, there are five yes-no pathways to a treatment choice. The first step of the algorithm is to test the ratio of TNF-alpha to interferon-gamma CD4+ T cells. A “yes’ response is produced if the ratio is greater than or equal to 2. These patients are then evaluated for the ratio of TNF-alpha to interferon-gamma CD8+ T cells. A yes response is produced if the ratio is greater than or equal to 0.5. If yes, they are candidates for a TNF-alpha inhibitor. If no, they are directed to an IL-12/23 inhibitor.

If the answer at the first decision point in the algorithm is a “no,” meaning they do not have a TNF-alpha to interferon-gamma CD4+ ratio of 2 or higher, they are evaluated for percentage of CD4+ T cells expressing IL-22 or IL-17. Is it greater than or equal to 2%? If the answer is “no,” they are candidates for an IL-12/23 inhibitor.

If “yes,” they are evaluated for percentage of IL-22 to IL-17 CD4+. If the IL-22 CD4+ percentage is lower than the IL-17 CD4+ percentage, meaning a “yes” to this decision point, they are directed to an IL-17 inhibitor. If the answer at this decision point is “no,” they are directed to an IL-12/23 inhibitor.

Prior to enrollment in this proof-of-concept study, 10 of the bDMARD patients were scheduled to receive an anti-TNF drug and 1 was scheduled to receive an IL-12/23 inhibitor. On the basis of this algorithm, only 5 patients were directed to an anti-TNF drug. Of the remaining, 5 were directed to an IL-17 inhibitor, and 1 was directed to an IL-12/23 inhibitor.

All 19 participants in the proof-of-concept study had peripheral arthritis; their median age was 45 years. Approximately 90% had skin lesions. Axial involvement was present in only one patient. Based on these and other characteristics and the median ratios of the cytokines measured, Dr. Ayan called this a representative population.

Based on the feasibility of this method for subtyping patients by T-cell behavior to guide drug selection, Dr. Ayan anticipates pursuing the additional steps that would show the algorithm makes a difference to patient care, including such adjunctive benefits as more cost-effective treatment selection.

“We aim to develop a treatment decision algorithm that can be implemented in daily practice,” Dr. Ayan said.

Is peripheral blood sampling adequate?

In addition to saying that the algorithm will need to prove that it alters outcomes, Samuel Tzen-yue Hwang, MD, PhD, professor and chair of the department of dermatology at the University of California, Davis, Sacramento, pointed out some potential practical issues.

“Flow cytometry is not typically available as a rapid throughput, and the cost is high,” he said. Moreover, he remains skeptical about performing this algorithm on the basis of peripheral blood samples.

“It is debatable that looking at peripheral cells would provide adequate information about what is taking place at sites of inflammation,” he said. Although it would “be fantastic” to develop an algorithm that required only a peripheral blood sample, he pointed out that “only a fraction of these cells is relevant” to disease activity.

Aspirating fluid from an involved joint “might be more useful,” but it is more work, he added. Yet, Dr. Hwang acknowledged that this approach is intriguing. He agreed that there is considerable heterogeneity among patients with PsA in their response to specific biologics, and a method to better direct patients to the treatment most likely to elicit a response is needed.

Dr. Ayan and Dr. Hwang reported no potential conflicts of interest.

NEW YORK – An algorithm in development for psoriatic arthritis (PsA) is showing promise for directing patients to the biologic with the greatest likelihood of producing disease control, according to a proof-of-concept study presented at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Our technique involves a more precise functional assay showing exact T-cell behavior, compared to the previous assessments that only analyzed cellular phenotypes,” reported Gizem Ayan, MD, a fellow in rheumatology at Hacettepe University Faculty of Medicine, Ankara, Turkey.

Ted Bosworth/MDedge News

The concept of precision medicine in PsA as well as other autoimmune diseases is not new. Phenotypes and biomarkers have already shown potential for guiding treatment, according to Dr. Ayan, but she said none are yet guideline recommended or proven to improve patient outcomes.

The principle of the new algorithm that she and her coinvestigators are pursing is based on immunophenotype analysis conducted with a flow-cytometric cytokine secretion assay (FCCSA). In the protocol, monocytes obtained from peripheral blood undergo activation before an FCCSA to distinguish patients by their T-cell behavior.

The treatment decision tree is based on median ratios of tumor necrosis factor (TNF)-alpha, interleukin (IL)–22, IL-17, and interferon-gamma expression among CD4+ and CD8+ cells. Based on a yes-or-no response to specific immune patterns, the patient is funneled to a biologic that inhibits a dominant cytokine.

The proof-of-concept study, which enrolled 8 patients with PsA who were naive to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and 11 patients with PsA who were naive to biologic DMARDs (bDMARDs), was designed to demonstrate feasibility. It did not test clinical benefit, but it did show that immunophenotyping with this methodology can be performed efficiently.

“From the time a blood sample is obtained, the method provided results within 24 hours,” according to Dr. Ayan, who is now planning a randomized trial to test the ability of the algorithm to improve clinical outcomes.

In the decision tree, there are five yes-no pathways to a treatment choice. The first step of the algorithm is to test the ratio of TNF-alpha to interferon-gamma CD4+ T cells. A “yes’ response is produced if the ratio is greater than or equal to 2. These patients are then evaluated for the ratio of TNF-alpha to interferon-gamma CD8+ T cells. A yes response is produced if the ratio is greater than or equal to 0.5. If yes, they are candidates for a TNF-alpha inhibitor. If no, they are directed to an IL-12/23 inhibitor.

If the answer at the first decision point in the algorithm is a “no,” meaning they do not have a TNF-alpha to interferon-gamma CD4+ ratio of 2 or higher, they are evaluated for percentage of CD4+ T cells expressing IL-22 or IL-17. Is it greater than or equal to 2%? If the answer is “no,” they are candidates for an IL-12/23 inhibitor.

If “yes,” they are evaluated for percentage of IL-22 to IL-17 CD4+. If the IL-22 CD4+ percentage is lower than the IL-17 CD4+ percentage, meaning a “yes” to this decision point, they are directed to an IL-17 inhibitor. If the answer at this decision point is “no,” they are directed to an IL-12/23 inhibitor.

Prior to enrollment in this proof-of-concept study, 10 of the bDMARD patients were scheduled to receive an anti-TNF drug and 1 was scheduled to receive an IL-12/23 inhibitor. On the basis of this algorithm, only 5 patients were directed to an anti-TNF drug. Of the remaining, 5 were directed to an IL-17 inhibitor, and 1 was directed to an IL-12/23 inhibitor.

All 19 participants in the proof-of-concept study had peripheral arthritis; their median age was 45 years. Approximately 90% had skin lesions. Axial involvement was present in only one patient. Based on these and other characteristics and the median ratios of the cytokines measured, Dr. Ayan called this a representative population.

Based on the feasibility of this method for subtyping patients by T-cell behavior to guide drug selection, Dr. Ayan anticipates pursuing the additional steps that would show the algorithm makes a difference to patient care, including such adjunctive benefits as more cost-effective treatment selection.

“We aim to develop a treatment decision algorithm that can be implemented in daily practice,” Dr. Ayan said.

Is peripheral blood sampling adequate?

In addition to saying that the algorithm will need to prove that it alters outcomes, Samuel Tzen-yue Hwang, MD, PhD, professor and chair of the department of dermatology at the University of California, Davis, Sacramento, pointed out some potential practical issues.

“Flow cytometry is not typically available as a rapid throughput, and the cost is high,” he said. Moreover, he remains skeptical about performing this algorithm on the basis of peripheral blood samples.

“It is debatable that looking at peripheral cells would provide adequate information about what is taking place at sites of inflammation,” he said. Although it would “be fantastic” to develop an algorithm that required only a peripheral blood sample, he pointed out that “only a fraction of these cells is relevant” to disease activity.

Aspirating fluid from an involved joint “might be more useful,” but it is more work, he added. Yet, Dr. Hwang acknowledged that this approach is intriguing. He agreed that there is considerable heterogeneity among patients with PsA in their response to specific biologics, and a method to better direct patients to the treatment most likely to elicit a response is needed.

Dr. Ayan and Dr. Hwang reported no potential conflicts of interest.

NEW YORK – An algorithm in development for psoriatic arthritis (PsA) is showing promise for directing patients to the biologic with the greatest likelihood of producing disease control, according to a proof-of-concept study presented at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

“Our technique involves a more precise functional assay showing exact T-cell behavior, compared to the previous assessments that only analyzed cellular phenotypes,” reported Gizem Ayan, MD, a fellow in rheumatology at Hacettepe University Faculty of Medicine, Ankara, Turkey.

Ted Bosworth/MDedge News

The concept of precision medicine in PsA as well as other autoimmune diseases is not new. Phenotypes and biomarkers have already shown potential for guiding treatment, according to Dr. Ayan, but she said none are yet guideline recommended or proven to improve patient outcomes.

The principle of the new algorithm that she and her coinvestigators are pursing is based on immunophenotype analysis conducted with a flow-cytometric cytokine secretion assay (FCCSA). In the protocol, monocytes obtained from peripheral blood undergo activation before an FCCSA to distinguish patients by their T-cell behavior.

The treatment decision tree is based on median ratios of tumor necrosis factor (TNF)-alpha, interleukin (IL)–22, IL-17, and interferon-gamma expression among CD4+ and CD8+ cells. Based on a yes-or-no response to specific immune patterns, the patient is funneled to a biologic that inhibits a dominant cytokine.

The proof-of-concept study, which enrolled 8 patients with PsA who were naive to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and 11 patients with PsA who were naive to biologic DMARDs (bDMARDs), was designed to demonstrate feasibility. It did not test clinical benefit, but it did show that immunophenotyping with this methodology can be performed efficiently.

“From the time a blood sample is obtained, the method provided results within 24 hours,” according to Dr. Ayan, who is now planning a randomized trial to test the ability of the algorithm to improve clinical outcomes.

In the decision tree, there are five yes-no pathways to a treatment choice. The first step of the algorithm is to test the ratio of TNF-alpha to interferon-gamma CD4+ T cells. A “yes’ response is produced if the ratio is greater than or equal to 2. These patients are then evaluated for the ratio of TNF-alpha to interferon-gamma CD8+ T cells. A yes response is produced if the ratio is greater than or equal to 0.5. If yes, they are candidates for a TNF-alpha inhibitor. If no, they are directed to an IL-12/23 inhibitor.

If the answer at the first decision point in the algorithm is a “no,” meaning they do not have a TNF-alpha to interferon-gamma CD4+ ratio of 2 or higher, they are evaluated for percentage of CD4+ T cells expressing IL-22 or IL-17. Is it greater than or equal to 2%? If the answer is “no,” they are candidates for an IL-12/23 inhibitor.

If “yes,” they are evaluated for percentage of IL-22 to IL-17 CD4+. If the IL-22 CD4+ percentage is lower than the IL-17 CD4+ percentage, meaning a “yes” to this decision point, they are directed to an IL-17 inhibitor. If the answer at this decision point is “no,” they are directed to an IL-12/23 inhibitor.

Prior to enrollment in this proof-of-concept study, 10 of the bDMARD patients were scheduled to receive an anti-TNF drug and 1 was scheduled to receive an IL-12/23 inhibitor. On the basis of this algorithm, only 5 patients were directed to an anti-TNF drug. Of the remaining, 5 were directed to an IL-17 inhibitor, and 1 was directed to an IL-12/23 inhibitor.

All 19 participants in the proof-of-concept study had peripheral arthritis; their median age was 45 years. Approximately 90% had skin lesions. Axial involvement was present in only one patient. Based on these and other characteristics and the median ratios of the cytokines measured, Dr. Ayan called this a representative population.

Based on the feasibility of this method for subtyping patients by T-cell behavior to guide drug selection, Dr. Ayan anticipates pursuing the additional steps that would show the algorithm makes a difference to patient care, including such adjunctive benefits as more cost-effective treatment selection.

“We aim to develop a treatment decision algorithm that can be implemented in daily practice,” Dr. Ayan said.

Is peripheral blood sampling adequate?

In addition to saying that the algorithm will need to prove that it alters outcomes, Samuel Tzen-yue Hwang, MD, PhD, professor and chair of the department of dermatology at the University of California, Davis, Sacramento, pointed out some potential practical issues.

“Flow cytometry is not typically available as a rapid throughput, and the cost is high,” he said. Moreover, he remains skeptical about performing this algorithm on the basis of peripheral blood samples.

“It is debatable that looking at peripheral cells would provide adequate information about what is taking place at sites of inflammation,” he said. Although it would “be fantastic” to develop an algorithm that required only a peripheral blood sample, he pointed out that “only a fraction of these cells is relevant” to disease activity.

Aspirating fluid from an involved joint “might be more useful,” but it is more work, he added. Yet, Dr. Hwang acknowledged that this approach is intriguing. He agreed that there is considerable heterogeneity among patients with PsA in their response to specific biologics, and a method to better direct patients to the treatment most likely to elicit a response is needed.

Dr. Ayan and Dr. Hwang reported no potential conflicts of interest.

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

The Biden administration issued guidance on July 13 to remind the nation’s 60,000 retail pharmacies of their obligation under federal law to supply prescribed medications, including drugs that may cause an abortion.

The Department of Health & Human Services listed several conditions that are commonly treated with drugs that can induce abortion, warning that withholding the pills could violate civil rights laws and could be considered discrimination based on sex or disability.

“We are committed to ensuring that everyone can access health care, free of discrimination,” Xavier Becerra, the U.S. health and human services secretary, said in a statement. “This includes access to prescription medications for reproductive health and other types of care.”

On July 11, Mr. Becerra issued other guidance to remind hospitals that federal law requires doctors to provide stabilizing treatment for patients with emergency medical conditions, which could include an abortion for those who arrive at emergency departments with a life-threatening issue.

Both actions by the Biden administration assert that federal laws override state laws that have banned or restricted abortion access since the Supreme Court overturned Roe v. Wade, according to The New York Times.

The guidance focuses on Section 1557 of the Affordable Care Act and related federal regulations, which state that recipients of federal financial assistance – including pharmacies that get Medicare and Medicaid payments – can’t discriminate based on race, color, national origin, sex, age, and disability. The guidance highlights that pregnancy discrimination includes discrimination based on current pregnancy, past pregnancy, potential or intended pregnancy, and medical conditions related to pregnancy or childbirth.

Three drugs in particular – mifepristone, misoprostol, and methotrexate – are often prescribed for other medical conditions but can also induce abortions in certain cases. Methotrexate, for example, is used for cancer and autoimmune disorders, such as rheumatoid arthritis.

Mifepristone is often used for patients with Cushing’s syndrome, while misoprostol is often prescribed for ulcers. When used in combination, the two drugs are authorized by the Food and Drug Administration to terminate a pregnancy during the first 10 weeks and after a miscarriage.

Since Roe was overturned, women have posted on social media that they were denied the drugs for their medical conditions due to being of “childbearing age.”

“These are very legitimate issues in terms of people being concerned about having access to the basic medications that they have been receiving for years, just because those medications have the capacity to end a pregnancy,” Alina Salganicoff, PhD, the director of women’s health policy at the Kaiser Family Foundation, told the Times.

“It doesn’t sound like [pharmacies] are blocking this for men,” she said.

The Biden administration’s guidance will likely be challenged in court, the newspaper reported. The update is cautiously written and doesn’t directly say that pharmacies must provide the drugs for the purpose of medication abortion.

In the meantime, pharmacists could feel stuck in the middle. Pharmacists who “believe they are acting in good faith in accordance with their state’s laws on abortion shouldn’t be left without a clear pathway forward,” the National Community Pharmacists Association said in a statement on July 13.

The association, which represents about 19,400 independent pharmacies across the United States, said pharmacies are regulated by states, and most states haven’t advised pharmacists on how to dispense the drugs in question.

“States have provided very little clarity on how pharmacists should proceed in light of conflicting state and federal laws and regulations,” B. Douglas Hoey, the association’s CEO, said in the statement.

“It is highly unfair for state and federal governments to threaten aggressive action against pharmacists who are just trying to serve their patients within new legal boundaries that are still taking shape,” he said.

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

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Body clocks and the shifting risks of stroke

Health care professionals, we’re sure, are no strangers to rotating shifts. And, as practitioners of the shiftly arts, you should know new research shows that working those kinds of hours can have lasting effects on your health. And it’s all based on your sleep-wake cycle.

Wildpixel/thinkstockphotos.com

In a study published in Neurobiology of Sleep and Circadian Rhythms, investigators at Texas A&M University looked at the effects of working these kinds of shifts for a long period of time and then returning to a regular 24-hour cycle later in life. The study piggybacks on a previous study, which showed that rats on shift schedules had more severe stroke outcomes than those who were on a 24-hour cycle.

The current study demonstrates that working rotating shifts does have a lasting effect, by way of messing with the sleep-wake cycle. Based on the research, the rats that performed those kinds of shifts never got back to a normal schedule. When strokes occurred, outcomes were much worse, and the females had a higher mortality rate and more severe functional deficits than the males.

Now for the “good” news: Even if you’re among those who haven’t worked a rotating shift, you may not be safe either.

People who have regular working hours have a tendency to take work home and stay up late, especially with so many moving to a remote-work model. And if you’re staying up late on the weekends you’re producing what lead author David J. Earnest, PhD, called “social jet lag,” which messes with your circadian rhythm to wind you down for sleep. All of these things can lead to the same kind of effects that working rotating shifts has on your health, he said in a written statement.

How do you combat this? Dr. Earnest recommended creating a sleep schedule and setting regular mealtimes. Also ease up on high-fat foods, drinking, and smoking. The connection between your brain and gut also could play a part in how severe a stroke can be.

So continue to work hard, but not too hard.

Got 3 minutes? You got time for culture

Much like a Krabby Patty, art is good for your soul. Seriously, staring at a 500-year-old painting may not seem like much, but research has proven time and again that going to a museum and looking at paintings by long-dead artists you probably know better as pizza-eating superhero turtles improves mood, stress, and well-being.

National Gallery of Art/rawpixel

A couple of years ago, however, museums and art galleries ran into a big virus-shaped problem. You may have heard of it. All of a sudden it became a very bad idea for people to gather together in one building and huddle around the Mona Lisa, which, by the way, is a lot smaller in person than you might expect. But, rather than sit around with a bunch of priceless art for an indeterminate amount of time, museums brought their exhibits to the Internet so that people from all over the world could see great works from their couches.

This is absolutely a good thing for public access, but do these virtual art exhibits provide the same health benefits as going to a museum in person? That’s what a group of European researchers aimed to find out, and in a study published in Frontiers of Psychology, that’s exactly what they found.

Their directive to the 84 study participants was simple: Take a well-being survey, engage with either of a pair of online exhibits (a Monet painting and a display of Japanese culinary traditions) for just 3 minutes, then take another well-being assessment. The results were quite clear: Even just a couple of minutes of viewing art online improved all the well-being categories on the survey, such as lowering anxiety, negative mood, and loneliness, as well as increasing subjective well-being. Also, the more beautiful or meaningful a person found the art, the more their mood and well-being improved.

The researchers noted that these results could help access in places where access to art is limited, such as waiting rooms, hospitals, and rural areas. Let’s just hope it sticks to that, and that big businesses don’t take notice. Just imagine them plastering ads with classic Renaissance artworks. After all, art makes you feel good, and you know what else feels good on a hot summer day? An ice-cold Coca-Cola! By the way, we’re taking offers, advertising agencies. The LOTME staff can absolutely be bought.

Appetite for etymology

Today on “It’s a Thing,” we examine various states of hunger and what they should be called. Our first guest is that historically hungry royal person, King Henry VIII of England. Your majesty, have you ever been “hangry?”

PxHere

KH8: First, let me thank you for inviting me on the show, Maurice. I’m a huge fan. A recent study done in the United Kingdom and Austria showed that “hunger is associated with greater levels of anger and irritability, as well as lower levels of pleasure,” according to a Eurekalert statement. So, yes, I have been “hangry.”

Maurice: Now to our next guest. Martha Stewart, can you add anything about that study?

Martha: Happy to, Maurice. The 64 participants used a smartphone app to record their hunger levels and emotional states five times a day for 21 days. It’s the first time that “hanger” was studied outside a lab, and it showed that hunger “was associated with 37% of the variance in irritability, 34% of the variance in anger, and 38% of the variance in pleasure recorded by the participants,” the investigators said in that statement.

Maurice: It’s official, then. Hangry is a thing, and we don’t need to put it in quotes anymore. Now let’s meet our third and final guest, Betty Crocker. Betty, I’m told you have a study to plug.

Betty: That’s right, Mo. Researchers at Tel Aviv University looked at survey data from almost 3,000 men and women and found that men ate 17% more food during the warmer months (March to September) than they did the rest of the year. Among women, however, caloric intake did not change.

KH8: I saw that study. Didn’t they put 27 people out in the sun and then take blood samples?

Betty: Indeed they did, Hank. After 25 minutes of sun exposure, the 13 men felt hungrier than before, but the 14 women did not. The men also had higher levels of ghrelin, an appetite-stimulating hormone, than the women.

Maurice: To sum all this up, then, we’ve got angry and hungry officially combining to make hangry, and now it looks like the sun is causing hunger in men, which makes them … sungry?

Martha: It’s a thing.

Chicken cutlets with a side of COVID

You stopped at the drive through at McDonald’s on the way home from work, and while you’re looking for something sweet in the refrigerator for dessert, you see that chicken breast that expires today.

Richard Franki/MDedge News

Freezing meat that’s about to expire might be your go-to so it doesn’t go to waste, but it’s been found that SARS-CoV-2 can live in meat that’s been in the refrigerator or freezer for more than a month.

Researchers exposed chicken, beef, pork, and salmon to surrogate viruses that are similar to COVID but not as harmful and stored them in freezers at –4° F and in the refrigerator at 39.2° F. “We even found that the viruses could be cultured after [being frozen for] that length of time,” lead author Emily Bailey, PhD, of Campbell University in Buies Creek, N.C., said in Study Finds.

The team began its research after hearing of COVID-19 outbreaks where there were no reports of community transmission, such as in Southeast Asia. Tracing eventually led to packaged meats as the culprits in those cases. SARS-CoV-2 is able to replicate in the gut, as well as the respiratory tract, so it could affect the gut before respiratory symptoms start. It is crucial to ensure cross contamination doesn’t occur, and inadequate sanitation prior to packaging needs to be addressed, the investigators said.

Honestly, we didn’t think anything could survive in a freezer for that long, but SARS-CoV-2 is a fighter.

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Americans could soon have a fourth option for COVID-19 vaccines after the Food and Drug Administration granted emergency use authorization to a two-shot vaccine from Novavax on July 13.

The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.

The Novavax vaccine is only for those who have not yet been vaccinated at all.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.

Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.

The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.

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

Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Results from a randomized controlled trial conducted in China found low-dose benzbromarone to be more effective in lowering serum urate levels than low-dose febuxostat (Uloric), with a similar safety profile, in gout with renal uric acid underexcretion.

Benzbromarone is not approved in the United States because of concerns of acute liver injury but is approved in several other countries, including China, Brazil, and New Zealand.

“The results suggest that low dosing of benzbromarone may warrant stronger consideration as a safe and effective therapy to achieve serum urate target in gout without moderate chronic kidney disease,” the study team writes.

“Benzbromarone is severely hepatotoxic in some individuals and unlikely to ever gain approval in the United States,” one of the study’s investigators, Robert Terkeltaub, MD, professor of medicine, University of California, San Diego, told this news organization.

However, this study “illustrates the value and impact of uricosuric therapy in general in gout, including potentially as an initial urate-lowering monotherapy strategy, and the sheer number of subjects reaching urate target with low-dose uricosuric monotherapy was impressive,” Dr. Terkeltaub said.

The study was published online  in Arthritis & Rheumatology.

“Renal uric acid underexcretion is the chief mechanism driving hyperuricemia in gout, yet the standard urate-lowering therapy recommendation is first-line xanthine oxidase inhibition irrespective of the cause of hyperuricemia,” the study team explains in their article.

Their prospective, randomized, single-center, open-labeled trial was conducted at the Gout Clinic of the Affiliated Hospital of Qingdao University, China.

A total of 196 relatively young healthy men with gout and uric acid underexcretion were randomly assigned to receive low-dose benzbromarone (25 mg/d) or low-dose febuxostat (20 mg/d) for 12 weeks.

Renal uric acid underexcretion was defined as fractional excretion of urate less than 5.5% and uric acid excretion less than or equal to 600 mg/d/1.73 m2.

A “major aspect” of this comparative effectiveness trial was its specific focus on gout-associated renal uric acid underexcretion, where the uricosuric targeted the dominant abnormality promoting the hyperuricemia, Dr. Terkeltaub told this news organization.

In addition, all participants received daily urine alkalinization with oral sodium bicarbonate. “This is not always done in clinical practice, nor in clinical trials of uricosuric agents,” Dr. Terkeltaub said.

The results showed that more participants in the benzbromarone group achieved the serum urate target of less than 6 mg/dL, compared with those in the febuxostat group (primary endpoint, 61% vs. 32%, P < .001).

Adverse events, including gout flares and urolithiasis, did not differ significantly between the two groups, with the exception of more transaminase elevation in the febuxostat group (15% vs. 4%; P = .008).

“We did not find severe hepatotoxicity with low-dose benzbromarone, but ethnic background may affect drug responses, and severe hepatotoxicity of benzbromarone has rarely been reported in Asia,” the authors write.

The incidence of urolithiasis was numerically, but not significantly, higher in the benzbromarone group (5% vs. 2%).

This study found no significant changes in participants’ triglyceride levels, though a previous study suggested febuxostat could increase serum triglycerides.

The investigators caution that the study only included patients who had baseline serum urate levels ranging from 8.0 to 10 mg/dL, who were relatively young and with few comorbidities.

The authors further noted that the “... results may not be generalizable to patients with higher serum urate levels or impaired kidney function, as well [as] patients from other geographical regions, age, and ethnicity groups. The study only included men, and the findings may not be generalizable to women with gout.”

‘Very useful’ in select cases

Weighing in on the results, Valderilio Feijó Azevedo, MD, PhD, adjunct professor of rheumatology, Federal University of Paraná, Brazil, noted that in some specific clinical circumstances, benzbromarone has been “a very useful medication, alone or combined, to treat gout patients.”

“We have great experience with the drug in Brazil. However, it is not used to treat all patients. Patients must be very well-selected in our clinical practice,” Dr. Azevedo said in an interview.

“For most patients, benzbromarone is effective for those who have failed to achieve serum uric acid goals with allopurinol treatment. We do not use it to treat patients with asymptomatic hyperuricemia. In general, we avoid patients with hepatic dysfunction due to previous hepatotoxicity reports. In every patient, we do active monitoring of enzymes,” Dr. Azevedo explained.

“We also avoid using it in patients with severe kidney disease. However, we have used it in some patients with estimated glomerular filtration rate less than 30. We also avoid dosage over 200 mg per day. On average, we use 100 mg per day combined with allopurinol or alone,” said Dr. Azevedo, who was not involved with the study.

Also weighing in, Michael Pillinger, MD, rheumatologist at NYU Langone Health, noted that while benzbromarone is not used in the United States, “in many parts of the world, it is used and is felt to be effective.” Dr. Pillinger was not associated with this current research.

This study, Dr. Pillinger said, “does underline the fact that an alternative drug that lowers urate by promoting urate excretion, if it could gain [U.S. Food and Drug Association] approval and if it were safe, could present a viable new option for therapy.”

He added, “If one conclusion to the study is that determining the basis of hyperuricemia is helpful in guiding benzbromarone use, that implies an additional layer of effort for physicians and patients in a disease that is already notoriously known for patient noncompliance – and in a case where febuxostat and allopurinol will work for both overproducers and underexcreters and would not need this additional assessment.”

The study was sponsored by Shandong Provincial Key Research and Development Plan, the National Natural Science Foundation of China, and Shandong Provincial Science Foundation for Outstanding Youth Scholarship. Dr. Terkeltaub was supported by the National Institutes of Health and the VA Research Service. Dr. Terkeltaub has received research funding from AstraZeneca, and has consulted with Horizon, Selecta, SOBI, Dyve BioSciences, Fortress, AstraZeneca, Allena, Fortress Biotech, and LG Life Sciences. Dr. Azevedo and Dr. Pillinger have no reported no relevant financial relationships.

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

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.

Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.

In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.

In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.

In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.

By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.

Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.

Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.

The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.

The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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

A commonly prescribed cancer and arthritis drug that is sometimes used as an oral abortifacient is facing prescription roadblocks in the wake of the Supreme Court’s overturning of Roe v. Wade.

The Court’s 5-4 decision in Dobbs v. Jackson Women’s Health Organization, which halted abortion procedures across the country, also appears to be affecting certain drug regimens. Reports have emerged that pharmacies are denying access to methotrexate (MTX), a drug often used in patients with arthritis or cancer, as well as psoriasis and other skin diseases. In very high doses, MTX it is used to terminate an ectopic pregnancy after miscarriage. The drug can also lead to birth defects.

“It’s happening all over,” Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, Fargo, said in an interview. “Pharmacists are reluctant to dispense it, and rheumatologists are reluctant to prescribe it because they’re afraid of going to jail.”

Becky Schwartz, a patient who takes MTX for lupus, recently tweeted that her physician’s office stopped prescribing the drug because it is considered an abortifacient. “I had care that made my disabled life easier, and [the Supreme Court] took that from me,” Ms. Schwartz wrote.

Prior to the Supreme Court’s ruling, physicians were concerned about the impact an overturning of the 1973 law would have on patient access to MTX and other prescription medications with abortifacient properties. Doctors in general are becoming afraid of prescribing anything that’s a teratogen, said Dr. Miller.

MTX is used far more often for autoimmune disease than as an abortifacient, said rheumatologist Kristen Young, MD, clinical assistant professor at the University of Arizona College of Medicine, Phoenix. It’s a slippery slope if states reacting to the Supreme Court ruling start regulating oral abortifacients, she added. Specifically, this will have a significant impact on patients with rheumatic disease.
 

Texas pharmacies target two drugs

MTX denials have caught the attention of health care organizations. “Uncertainty in financial and criminal liability for health care professionals in certain state laws and regulations are possibly compromising continuity of care and access [to] medications proven to be safe and effective by the Food and Drug Administration for these indications,” warned the American Pharmacists Association (APhA) in a statement to this news organization.

The APhA said that it was monitoring this situation to assess the effect on patients and pharmacists.

The Arthritis Foundation was made aware of challenges from patients in accessing their MTX prescription for managing their arthritis and shared a statement on the Foundation’s website.

In Texas, pharmacists can refuse to fill scripts for misoprostol and MTX, a combination used for medical abortions. According to the foundation, “Already there are reports that people in Texas who miscarry or take methotrexate for arthritis [are] having trouble getting their prescriptions filled.”

MTX, approved by the FDA in 1985, “is the absolute cornerstone of rheumatoid arthritis. We cannot deny our patients this incredibly valuable drug,” said John Reveille, MD, vice-chair for the department of medicine at the University of Texas McGovern School of Medicine and a member of the Arthritis Foundation expert panel, in an interview.

“While it’s true that methotrexate can be lethal to the fetus, misoprostol is much more likely to cause a spontaneous abortion, and the combination is especially effective,” he said.

“If you look at Cochrane clinical studies, the dose of misoprostol contained in certain combinations with NSAIDs [nonsteroidal anti-inflammatory drugs] can induce spontaneous abortions. It’s surprising that pharmacists are targeting methotrexate, an essential drug in arthritis treatment, when there are medications available that do not have this benefit that can by themselves cause loss of the fetus, such as mifepristone,” added Dr. Reveille.

The Dobbs ruling could also affect the ability of oncologists to provide lifesaving cancer care, according to Jason Westin, MD, an oncologist at the University of Texas MD Anderson Cancer Center in the department of lymphoma and myeloma.

“We have heard of medications with multiple indications, such as methotrexate, not being dispensed by pharmacies due to confusion regarding the intended use and potential consequences for the health care team,” he said in an interview.
 

Conflicting laws pose challenges for physicians

In North Dakota, inconsistencies in several laws are making it difficult for physicians and pharmacists to make decisions. “Lots of confusion can result when people pass laws against abortion. There’s sometimes no insight into the ramifications of those laws,” said Dr. Miller.

North Dakota approved a trigger law several years ago that makes abortion illegal 30 days after an overturning of Roe. However, another law that regulates abortion conflicts with the trigger law. “Some of the language will need clarification in the next legislative session,” he said.

APhA and other pharmacy associations strongly favor not interfering with the doctor- or pharmacist-patient relationship. The law needs to defer to appropriate care between doctor and patient, said Dr. Miller. State pharmacy associations in North Dakota are working with legislatures to clarify any exceptions in the law, he added.

Arizona lawmakers are trying to reconcile two abortion laws on the books. One, based on an 1864 territorial law, deems abortion illegal. In addition, a newly approved law bans abortions after 15 weeks. The latter will go into effect in September 2022. In both laws, a risk to the mother’s life is the only exception for abortion, said Dr. Young.
 

Denials aren’t widespread

Not all doctors are seeing MTX denials, but they’re worried about the future. “To date, we have not encountered difficulty in obtaining methotrexate based upon state abortion restrictions but are concerned that this could occur and result in dangerous delays in care,” said Dr. Westin.

Dr. Reveille, who practices rheumatology in Houston, has not yet received any complaints from patients. Things may be different in more rural parts of Texas, where pharmacists could be denying prescriptions based on religious issues, he offered.

It’s a little soon to see what repercussions may result from the Supreme Court ruling and state actions, said Dr. Reveille. “In Texas, we’re a bit ahead of the tidal wave.”

Access problems also haven’t shown up at the university clinic where Dr. Young practices. “In Arizona, it’s unclear if there would be a legal basis to refuse a person methotrexate on the basis that it can be used as an abortifacient,” she said.

Specificity is key in writing Rx scripts

Physicians can make things easier for patients by writing the indication and dose for the drug on the prescription slip. For example, a 10-mg script for MTX is not going to be used for an abortion, said Dr. Miller.

Rheumatologists in Texas have been doing this for some time, even before the Supreme Court ruling, said Fehmida Zahabi, MD, FACR, president of the Society of Texas Association of Rheumatology. For MTX prescriptions in premenopausal women, “patients are told their doctor needs to call the pharmacist. In the small print, we are asked to give a diagnosis to make sure we aren’t using it to terminate pregnancies,” said Dr. Zahabi.

She further noted that if the diagnosis is already indicated on the script, pharmacies generally won’t give patients a hard time.

Patients can also ask their physicians for a letter of medical necessity that confirms a drug’s use for a specific medical condition.

Mail order is another option if a local pharmacy won’t fill a prescription, said Dr. Miller. “This is legal unless a state makes it illegal to send an abortifacient across state lines,” he added.

Many medications used in rheumatic diseases are harmful in pregnancy, and it’s important to routinely discuss pregnancy risk and planning in the rheumatology clinic, said Dr. Young. This should include a thorough discussion and referral for long-acting reversible contraception in most cases, she suggested.
 

Actions at the federal, state level 

President Joe Biden recently signed an executive order prompting federal regulators to protect access to medication abortions, among other steps to safeguard access to reproductive services.

In a statement on Twitter, the American College of Rheumatology (ACR) said that it was “ ... following this issue closely to determine if rheumatology providers and patients are experiencing any widespread difficulty accessing methotrexate or if any initial disruptions are potentially temporary and due to the independent actions of pharmacists trying to figure out what is and isn’t allowed where they practice.”

ACR has assembled a task force of medical and policy experts to determine the best course of action for patients.

The Arthritis Foundation also continues to monitor the situation, encouraging patients to call its hotline, said Steven Schultz, director of state legislative affairs, in an interview.

“We are analyzing how medication abortion could cause confusion on the part of providers or pharmacists dispensing the medication and what this means for specific patients,” said Mr. Schultz. Through a survey, the foundation hopes to get a better idea of what’s going on in the states at a macro level.

This may take some time, as states go through a process of lawsuits, injunctions, or coming into session to do something that may affect access to MTX, said Mr. Schultz.

Being involved in local advocacy is more important than ever, stressed Dr. Young. “Additionally, being plugged into what the ACR and other advocacy groups are doing on the national level is helpful as well to know the status of these medication access issues.”

Rheumatologists have a unique voice in this discussion, she added. “We guide our patients to stability for a safe pregnancy, and even with careful planning, we see patients who become critically ill during pregnancy and require lifesaving treatment, which at times can mean an abortion is necessary.”

Oncologists also advocate for their patients on a regular basis to make sure they have access to the care they need, said Dr. Westin. This situation with Roe is no different, he added. “We will continue to use our unique expertise to advocate for policies that assure access to high-quality, evidence-based care – and to help our patients overcome barriers that may interfere.”

Dr. Reveille participated on an advisory board with Eli Lilly in October 2021.

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