MDedge Dermatology

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at [email protected].

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at [email protected].

The term “reform school” is a bit outdated. It used to refer to institutions where young offenders were sent instead of prison. Some argue that pharmacy benefit managers (PBMs) should bypass reform school and go straight to prison. “PBM reform” has become a ubiquitous term, encompassing any legislative or regulatory efforts aimed at curbing PBMs’ bad behavior. When discussing PBM reform, it’s crucial to understand the various segments of the healthcare system affected by PBMs. This complexity often makes it challenging to determine what these reform packages would actually achieve and who they would benefit.

Pharmacists have long been vocal critics of PBMs, and while their issues are extremely important, it is essential to remember that the ultimate victims of PBM misconduct, in terms of access to care, are patients. At some point, we will all be patients, making this issue universally relevant. It has been quite challenging to follow federal legislation on this topic as these packages attempt to address a number of bad behaviors by PBMs affecting a variety of victims. This discussion will examine those reforms that would directly improve patient’s access to available and affordable medications.
 

Policy Categories of PBM Reform

There are five policy categories of PBM reform legislation overall, including three that have the greatest potential to directly address patient needs. The first is patient access to medications (utilization management, copay assistance, prior authorization, etc.), followed by delinking drug list prices from PBM income and pass-through of price concessions from the manufacturer. The remaining two categories involve transparency and pharmacy-facing reform, both of which are very important. However, this discussion will revolve around the first three categories. It should be noted that many of the legislation packages addressing the categories of patient access, delinking, and pass-through also include transparency issues, particularly as they relate to pharmacy-facing issues.

Patient Access to Medications — Step Therapy Legislation

One of the major obstacles to patient access to medications is the use of PBM utilization management tools such as step therapy (“fail first”), prior authorizations, nonmedical switching, and formulary exclusions. These tools dictate when patients can obtain necessary medications and for how long patients who are stable on their current treatments can remain on them.

While many states have enacted step therapy reforms to prevent stable patients from being whip-sawed between medications that maximize PBM profits (often labeled as “savings”), these state protections apply only to state-regulated health plans. These include fully insured health plans and those offered through the Affordable Care Act’s Health Insurance Marketplace. It also includes state employees, state corrections, and, in some cases, state labor unions. State legislation does not extend to patients covered by employer self-insured health plans, called ERISA plans for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act. These ERISA plans include nearly 35 million people nationwide.

This is where the Safe Step Act (S.652/H.R.2630) becomes crucial, as it allows employees to request exceptions to harmful fail-first protocols. The bill has gained significant momentum, having been reported out of the Senate HELP Committee and discussed in House markups. The Safe Step Act would mandate that an exception to a step therapy protocol must be granted if:

• The required treatment has been ineffective
• The treatment is expected to be ineffective, and delaying effective treatment would lead to irreversible consequences
• The treatment will cause or is likely to cause an adverse reaction
• The treatment is expected to prevent the individual from performing daily activities or occupational responsibilities
• The individual is stable on their current prescription drugs
• There are other circumstances as determined by the Employee Benefits Security Administration

This legislation is vital for ensuring that patients have timely access to the medications they need without unnecessary delays or disruptions.
 

Patient Access to Medications — Prior Authorizations

Another significant issue affecting patient access to medications is prior authorizations (PAs). According to an American Medical Association survey, nearly one in four physicians (24%) report that a PA has led to a serious adverse event for a patient in their care. In rheumatology, PAs often result in delays in care (even for those initially approved) and a significant increase in steroid usage. In particular, PAs in Medicare Advantage (MA) plans are harmful to Medicare beneficiaries.

The Improving Seniors’ Timely Access to Care Act (H.R.8702 / S.4532) aims to reform PAs used in MA plans, making the process more efficient and transparent to improve access to care for seniors. Unfortunately, it does not cover Part D drugs and may only cover Part B drugs depending on the MA plan’s benefit package. Here are the key provisions of the act:

• Electronic PA: Implementing real-time decisions for routinely approved items and services.
• Transparency: Requiring annual publication of PA information, such as the percentage of requests approved and the average response time.
• Quality and Timeliness Standards: The Centers for Medicare & Medicaid Services (CMS) will set standards for the quality and timeliness of PA determinations.
• Streamlining Approvals: Simplifying the approval process and reducing the time allowed for health plans to consider PA requests.

This bill passed the House in September 2022 but stalled in the Senate because of an unfavorable Congressional Budget Office score. CMS has since finalized portions of this bill via regulation, zeroing out the CBO score and increasing the chances of its passage.
 

Delinking Drug Prices from PBM Income and Pass-Through of Price Concessions

Affordability is a crucial aspect of accessibility, especially when it comes to medications. Over the years, we’ve learned that PBMs often favor placing the highest list price drugs on formularies because the rebates and various fees they receive from manufacturers are based on a percentage of the list price. In other words, the higher the medication’s price, the more money the PBM makes.

This practice is evident in both commercial and government formularies, where brand-name drugs are often preferred, while lower-priced generics are either excluded or placed on higher tiers. As a result, while major PBMs benefit from these rebates and fees, patients continue to pay their cost share based on the list price of the medication.

To improve the affordability of medications, a key aspect of PBM reform should be to disincentivize PBMs from selecting higher-priced medications and/or require the pass-through of manufacturer price concessions to patients.

Several major PBM reform bills are currently being considered that address either the delinking of price concessions from the list price of the drug or some form of pass-through of these concessions. These reforms are essential to ensure that patients can access affordable medications without being burdened by inflated costs.

The legislation includes the Pharmacy Benefit Manager Reform Act (S.1339); the Modernizing & Ensuring PBM Accountability Act (S.2973); the Better Mental Health Care, Lower Cost Drugs, and Extenders Act (S.3430); the Protecting Patients Against PBM Abuses Act (H.R. 2880); the DRUG Act (S.2474 / H.R.6283); and the Share the Savings with Seniors Act (S.2474 / H.R.5376).

As with all legislation, there are limitations and compromises in each of these. However, these bills are a good first step in addressing PBM remuneration (rebates and fees) based on the list price of the drug and/or passing through to the patient the benefit of manufacturer price concessions. By focusing on key areas like utilization management, delinking drug prices from PBM income, and allowing patients to directly benefit from manufacturer price concessions, we can work toward a more equitable and efficient healthcare system. Reigning in PBM bad behavior is a challenge, but the potential benefits for patient care and access make it a crucial fight worth pursuing.

Please help in efforts to improve patients’ access to available and affordable medications by contacting your representatives in Congress to impart to them the importance of passing legislation. The CSRO’s legislative map tool can help to inform you of the latest information on these and other bills and assist you in engaging with your representatives on them.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of Advocacy and Government Affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. She has no relevant conflicts of interest to disclose. You can reach her at [email protected].

TOPLINE:

A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.

METHODOLOGY:

• Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
• A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
• The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
• The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.

TAKEAWAY:

• At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
• The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
• The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
• Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.

IN PRACTICE:

“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.

SOURCE:

This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.

LIMITATIONS: 

Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.

DISCLOSURES:

The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.

METHODOLOGY:

• Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
• A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
• The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
• The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.

TAKEAWAY:

• At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
• The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
• The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
• Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.

IN PRACTICE:

“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.

SOURCE:

This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.

LIMITATIONS: 

Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.

DISCLOSURES:

The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

A greater proportion of patients with active systemic lupus erythematosus (SLE) treated with belimumab plus standard therapy achieved the newest definitions for remission and low disease activity compared with those treated with placebo plus standard therapy, with benefits observed as early as week 28 for remission and week 8 for disease activity, according to pooled results from five clinical trials.

METHODOLOGY:

• Researchers conducted an integrated post hoc analysis of five randomized phase 3 clinical trials to evaluate the attainment of remission and low disease activity in adult patients with active, autoantibody-positive SLE.
• A total of 3086 patients (median age, 36 years; 94% women) were randomly assigned to receive standard therapy with intravenous belimumab 10 mg/kg monthly or subcutaneous belimumab 200 mg weekly (n = 1869) or placebo (n = 1217).
• The proportion of patients who achieved definitions of remission in SLE (DORIS) remission and lupus low disease activity state (LLDAS) by visit up to week 52 was assessed.
• The analysis also evaluated the time taken to achieve sustained (at least two consecutive visits) and maintained (up to week 52) DORIS remission and LLDAS.

TAKEAWAY:

• At week 52, a higher proportion of patients receiving belimumab vs placebo achieved DORIS remission (8% vs 6%; risk ratio [RR], 1.51; P = .0055) and LLDAS (17% vs 10%; RR, 1.74; P < .0001).
• The earliest observed significant benefit of belimumab over placebo in patients with a higher baseline disease activity was at week 20 for DORIS remission (RR, 2.09; P = .043) and at week 16 for LLDAS (RR, 1.46; P = .034), with both maintained through week 52.
• The proportion of patients who attained DORIS remission and LLDAS as early as week 28 and week 8, respectively, was higher in the belimumab group than in the placebo group, with both maintained through week 52.
• Patients on belimumab were more likely to have a sustained and maintained DORIS remission (hazard ratio [HR], 1.53; P = .013) and LLDAS (HR, 1.79; P < .0001) at any timepoint.

IN PRACTICE:

“The data clearly support that belimumab is a valuable addition toward accomplishing and maintaining remission or LLDAS,” George Bertsias, MD, PhD, University of Crete Medical School, Heraklion, Greece, and Jinoos Yazdany, MD, University of California San Francisco, wrote in a related comment.

SOURCE:

This study, led by Ioannis Parodis, MD, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden, was published online on August 26, 2024, in The Lancet Rheumatology.

LIMITATIONS: 

Due to the post hoc nature of the analysis, the trials were not specifically designed to have adequate statistical power to demonstrate the difference between patients who did or did not achieve DORIS remission or LLDAS. The analysis was limited to patients who met the eligibility criteria, and the outcomes are not generalizable to populations outside a clinical trial setting. The study population had high disease activity, which made it challenging to attain the treatment targets.

DISCLOSURES:

The five trials included in this analysis were funded by GSK. The study was supported by the Swedish Rheumatism Association, King Gustaf V’s 80-year Foundation, the Swedish Society of Medicine, Nyckelfonden, Professor Nanna Svartz Foundation, Ulla and Roland Gustafsson Foundation, Region Stockholm, and Karolinska Institutet. Some authors reported receiving grants, speaker honoraria, or consulting fees from various pharmaceutical companies. Some authors reported being employees and owning stocks and shares of GSK.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An artificial intelligence (AI)-powered clinical documentation tool helped reduce time spent on electronic health records (EHR) at home for almost 48% physicians, and nearly 45% reported less weekly time spent on EHR tasks outside of normal work hours.

METHODOLOGY:

• Researchers recruited 112 clinicians from family medicine, internal medicine, and general pediatrics in North Carolina and Georgia.
• Patients were divided into an intervention group (n = 85) and control group (n = 55), with the intervention group receiving a 1-hour training program on a commercially available AI tool.
• A seven-question survey was administered to participants before and 5 weeks after the intervention to evaluate their experience.

TAKEAWAY:

• The researchers found 47.1% of clinicians in the intervention group reported spending less time on the EHR at home compared with 14.5% in the control group (P < .001); 44.7% reported decreased weekly time on the EHR outside normal work hours compared with 20% in the control group (P = .003).
• The study revealed 43.5% of physicians who used the AI instrument reported spending less time on documentation after visits compared with 18.2% in the control group (P = .002).
• Further, 44.7% reported less frustration when using the EHR compared with 14.5% in the control group (P < .001).

IN PRACTICE:

“Approximately half of clinicians using the AI-powered clinical documentation tool based on interest reported a positive outcome, potentially reducing burnout. However, a significant subset did not find time-saving benefits or improved EHR experience,” the authors of the study wrote.

SOURCE:

The study was led by Tsai-Ling Liu, PhD, Center for Health System Sciences, Atrium Health in Charlotte, North Carolina. It was published online in JAMA Network Open.

LIMITATIONS:

The researchers reported potential selection and recall bias in both groups. Additional research is needed to find areas of improvement and assess the effects on clinician groups and health systems, they said.

DISCLOSURES:

Andrew McWilliams, MD, MPH, reported receiving grants from the Agency for Healthcare Research Quality, the National Institutes of Health, and the Duke Endowment unrelated to this work. Ajay Dharod, MD, reported his role as an electronic health record consultant for the Association of American Medical College CORE program. Jeffrey Cleveland, MD, disclosed his participation on the Executive Client Council, a noncompensated advisory group, for Nuance/Microsoft.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

To the Editor:

Kratom (Mitragyna speciosa) is an evergreen tree native to Southeast Asia.¹ Its leaves contain psychoactive compounds including mitragynine and 7-­hydroxymitragynine, which exert dose-dependent effects on the central nervous system through opioid and monoaminergic receptors.^2,3 At low doses (1–5 g), kratom elicits mild stimulant effects such as increased sociability, alertness, and talkativeness. At high doses (5–15 g), kratom has depressant effects that can provide relief from pain and opioid-withdrawal symptoms.³

Traditionally, kratom has been used in Southeast Asia for recreational and ceremonial purposes, to ease opioid-withdrawal symptoms, and to reduce fatigue from manual labor.⁴ In the 21st century, availability of kratom expanded to Europe, Australia, and the United States, largely facilitated by widespread dissemination of deceitful ­marketing and unregulated sales on the internet.¹ Although large-scale epidemiologic studies evaluating kratom’s prevalence are scarce, available evidence indicates rising worldwide usage, with a notable increase in kratom-related poison center calls between 2011 and 2017 in the United States.⁵ In July 2023, kratom made headlines due to the death of a woman in Florida following use of the substance.⁶

A cross-sectional study revealed that in the United States, kratom typically is used by White individuals for self-treatment of anxiety, depression, pain, and opioid withdrawal.⁷ However, the potential for severe adverse effects and dependence on kratom can outweigh the benefits.^6,8 Reported adverse effects of kratom include tachycardia, hypercholesteremia, liver injury, hallucinations, respiratory depression, seizure, coma, and death.^9,10 We present a case of kratom-induced photodistributed hyperpigmentation.

A 63-year-old man presented to the dermatology clinic with diffuse tender, pruritic, hyperpigmented skin lesions that developed over the course of 1 year. The lesions were distributed on sun-exposed areas, including the face, neck, and forearms (Figure 1). The patient reported no other major symptoms, and his health was otherwise unremarkable. He had a medical history of psoriasiform and spongiotic dermatitis consistent with eczema, psoriasis, hypercholesteremia, and hyperlipidemia. The patient was not taking any medications at the time of presentation. He had a family history of plaque psoriasis in his father. Five years prior to the current presentation, the patient was treated with adalimumab for steroid-resistant psoriasis; however, despite initial improvement, he experienced recurrence of scaly erythematous plaques and had discontinued adalimumab the year prior to presentation.

To the Editor:

Kratom (Mitragyna speciosa) is an evergreen tree native to Southeast Asia.¹ Its leaves contain psychoactive compounds including mitragynine and 7-­hydroxymitragynine, which exert dose-dependent effects on the central nervous system through opioid and monoaminergic receptors.^2,3 At low doses (1–5 g), kratom elicits mild stimulant effects such as increased sociability, alertness, and talkativeness. At high doses (5–15 g), kratom has depressant effects that can provide relief from pain and opioid-withdrawal symptoms.³

Traditionally, kratom has been used in Southeast Asia for recreational and ceremonial purposes, to ease opioid-withdrawal symptoms, and to reduce fatigue from manual labor.⁴ In the 21st century, availability of kratom expanded to Europe, Australia, and the United States, largely facilitated by widespread dissemination of deceitful ­marketing and unregulated sales on the internet.¹ Although large-scale epidemiologic studies evaluating kratom’s prevalence are scarce, available evidence indicates rising worldwide usage, with a notable increase in kratom-related poison center calls between 2011 and 2017 in the United States.⁵ In July 2023, kratom made headlines due to the death of a woman in Florida following use of the substance.⁶

A cross-sectional study revealed that in the United States, kratom typically is used by White individuals for self-treatment of anxiety, depression, pain, and opioid withdrawal.⁷ However, the potential for severe adverse effects and dependence on kratom can outweigh the benefits.^6,8 Reported adverse effects of kratom include tachycardia, hypercholesteremia, liver injury, hallucinations, respiratory depression, seizure, coma, and death.^9,10 We present a case of kratom-induced photodistributed hyperpigmentation.

A 63-year-old man presented to the dermatology clinic with diffuse tender, pruritic, hyperpigmented skin lesions that developed over the course of 1 year. The lesions were distributed on sun-exposed areas, including the face, neck, and forearms (Figure 1). The patient reported no other major symptoms, and his health was otherwise unremarkable. He had a medical history of psoriasiform and spongiotic dermatitis consistent with eczema, psoriasis, hypercholesteremia, and hyperlipidemia. The patient was not taking any medications at the time of presentation. He had a family history of plaque psoriasis in his father. Five years prior to the current presentation, the patient was treated with adalimumab for steroid-resistant psoriasis; however, despite initial improvement, he experienced recurrence of scaly erythematous plaques and had discontinued adalimumab the year prior to presentation.

To the Editor:

Kratom (Mitragyna speciosa) is an evergreen tree native to Southeast Asia.¹ Its leaves contain psychoactive compounds including mitragynine and 7-­hydroxymitragynine, which exert dose-dependent effects on the central nervous system through opioid and monoaminergic receptors.^2,3 At low doses (1–5 g), kratom elicits mild stimulant effects such as increased sociability, alertness, and talkativeness. At high doses (5–15 g), kratom has depressant effects that can provide relief from pain and opioid-withdrawal symptoms.³

Traditionally, kratom has been used in Southeast Asia for recreational and ceremonial purposes, to ease opioid-withdrawal symptoms, and to reduce fatigue from manual labor.⁴ In the 21st century, availability of kratom expanded to Europe, Australia, and the United States, largely facilitated by widespread dissemination of deceitful ­marketing and unregulated sales on the internet.¹ Although large-scale epidemiologic studies evaluating kratom’s prevalence are scarce, available evidence indicates rising worldwide usage, with a notable increase in kratom-related poison center calls between 2011 and 2017 in the United States.⁵ In July 2023, kratom made headlines due to the death of a woman in Florida following use of the substance.⁶

A cross-sectional study revealed that in the United States, kratom typically is used by White individuals for self-treatment of anxiety, depression, pain, and opioid withdrawal.⁷ However, the potential for severe adverse effects and dependence on kratom can outweigh the benefits.^6,8 Reported adverse effects of kratom include tachycardia, hypercholesteremia, liver injury, hallucinations, respiratory depression, seizure, coma, and death.^9,10 We present a case of kratom-induced photodistributed hyperpigmentation.

A 63-year-old man presented to the dermatology clinic with diffuse tender, pruritic, hyperpigmented skin lesions that developed over the course of 1 year. The lesions were distributed on sun-exposed areas, including the face, neck, and forearms (Figure 1). The patient reported no other major symptoms, and his health was otherwise unremarkable. He had a medical history of psoriasiform and spongiotic dermatitis consistent with eczema, psoriasis, hypercholesteremia, and hyperlipidemia. The patient was not taking any medications at the time of presentation. He had a family history of plaque psoriasis in his father. Five years prior to the current presentation, the patient was treated with adalimumab for steroid-resistant psoriasis; however, despite initial improvement, he experienced recurrence of scaly erythematous plaques and had discontinued adalimumab the year prior to presentation.

TOPLINE:

Reports of blood and lymphatic disorders were higher in pediatric patients treated with Janus kinase (JAK) inhibitors than in adults in a review of US and Canadian adverse event (AE) data, which also found that acne was the most common skin-related AE in children, and serious AEs were less common.

METHODOLOGY:

• Researchers analyzed 399,649 AEs in 133,216 adult patients and 2883 AEs in 955 pediatric patients (age, < 18 years) from November 2011 to February 2023 using the US Food and Drug Administration Adverse Event Reporting System and the Canada Vigilance Adverse Reaction Online Database.
• AEs were categorized on the basis of the Medical Dictionary for Regulatory Activities system organ class.
• Five JAK inhibitors approved for use in children were included in the study: Baricitinib, upadacitinib, abrocitinib, ruxolitinib, and tofacitinib.

TAKEAWAY:

• The most frequently reported AEs in children were blood and lymphatic system disorders, including neutropenia, thrombocytopenia, and anemia (24%); viral, fungal, and bacterial infections, such as pneumonia and sepsis (17.2%); constitutional symptoms and administrative concerns, including pyrexia and fatigue (15.7%); gastrointestinal disorders, such as vomiting and abdominal pain (13.6%); and respiratory disorders, such as cough and respiratory distress (5.3%).
• In adults, the most common AEs were viral, fungal, and bacterial infections (16.8%); constitutional symptoms and administrative concerns (13.5%); musculoskeletal and connective tissue disorders (7.04%); and gastrointestinal (5.8%) and nervous system (5%) disorders.
• Acne (30.6%), atopic dermatitis (22.2%), and psoriasis (16.7%) were the most common skin and subcutaneous tissue AEs reported in children. Skin and subcutaneous AEs were more common with upadacitinib (21.1%), abrocitinib (9.1%), and tofacitinib (6.3%) in children.
• Serious AEs included in the boxed warning for JAK inhibitors — serious infection, mortality, malignancy, cardiovascular events, and thrombosis — were similar for baricitinib in children (4 of 49 patients, 8.2%) and adults (325 of 3707, 8.8%). For other JAK inhibitors, absolute numbers of these AEs in children were small and rates were lower in children than in adults.

IN PRACTICE:

“This information can support customized treatment and minimize the potential for undesired or intolerable AEs,” the authors wrote.

SOURCE:

This study was led by Sahithi Talasila, BS, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and was published online in Pediatric Dermatology.

LIMITATIONS:

Pharmacovigilance registries did not fully capture the complete range of AEs because of potential reporting bias or recall bias. Additionally, events lacking sufficient objective evidence were underreported, while common AEs associated with JAK inhibitor therapy were overreported.

DISCLOSURES:

No specific funding sources for the study were reported. One author reported being a consultant, one reported serving as a principal investigator in clinical trials, and another reported serving on data and safety monitoring boards of various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Reports of blood and lymphatic disorders were higher in pediatric patients treated with Janus kinase (JAK) inhibitors than in adults in a review of US and Canadian adverse event (AE) data, which also found that acne was the most common skin-related AE in children, and serious AEs were less common.

METHODOLOGY:

• Researchers analyzed 399,649 AEs in 133,216 adult patients and 2883 AEs in 955 pediatric patients (age, < 18 years) from November 2011 to February 2023 using the US Food and Drug Administration Adverse Event Reporting System and the Canada Vigilance Adverse Reaction Online Database.
• AEs were categorized on the basis of the Medical Dictionary for Regulatory Activities system organ class.
• Five JAK inhibitors approved for use in children were included in the study: Baricitinib, upadacitinib, abrocitinib, ruxolitinib, and tofacitinib.

TAKEAWAY:

• The most frequently reported AEs in children were blood and lymphatic system disorders, including neutropenia, thrombocytopenia, and anemia (24%); viral, fungal, and bacterial infections, such as pneumonia and sepsis (17.2%); constitutional symptoms and administrative concerns, including pyrexia and fatigue (15.7%); gastrointestinal disorders, such as vomiting and abdominal pain (13.6%); and respiratory disorders, such as cough and respiratory distress (5.3%).
• In adults, the most common AEs were viral, fungal, and bacterial infections (16.8%); constitutional symptoms and administrative concerns (13.5%); musculoskeletal and connective tissue disorders (7.04%); and gastrointestinal (5.8%) and nervous system (5%) disorders.
• Acne (30.6%), atopic dermatitis (22.2%), and psoriasis (16.7%) were the most common skin and subcutaneous tissue AEs reported in children. Skin and subcutaneous AEs were more common with upadacitinib (21.1%), abrocitinib (9.1%), and tofacitinib (6.3%) in children.
• Serious AEs included in the boxed warning for JAK inhibitors — serious infection, mortality, malignancy, cardiovascular events, and thrombosis — were similar for baricitinib in children (4 of 49 patients, 8.2%) and adults (325 of 3707, 8.8%). For other JAK inhibitors, absolute numbers of these AEs in children were small and rates were lower in children than in adults.

IN PRACTICE:

“This information can support customized treatment and minimize the potential for undesired or intolerable AEs,” the authors wrote.

SOURCE:

This study was led by Sahithi Talasila, BS, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and was published online in Pediatric Dermatology.

LIMITATIONS:

Pharmacovigilance registries did not fully capture the complete range of AEs because of potential reporting bias or recall bias. Additionally, events lacking sufficient objective evidence were underreported, while common AEs associated with JAK inhibitor therapy were overreported.

DISCLOSURES:

No specific funding sources for the study were reported. One author reported being a consultant, one reported serving as a principal investigator in clinical trials, and another reported serving on data and safety monitoring boards of various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Reports of blood and lymphatic disorders were higher in pediatric patients treated with Janus kinase (JAK) inhibitors than in adults in a review of US and Canadian adverse event (AE) data, which also found that acne was the most common skin-related AE in children, and serious AEs were less common.

METHODOLOGY:

• Researchers analyzed 399,649 AEs in 133,216 adult patients and 2883 AEs in 955 pediatric patients (age, < 18 years) from November 2011 to February 2023 using the US Food and Drug Administration Adverse Event Reporting System and the Canada Vigilance Adverse Reaction Online Database.
• AEs were categorized on the basis of the Medical Dictionary for Regulatory Activities system organ class.
• Five JAK inhibitors approved for use in children were included in the study: Baricitinib, upadacitinib, abrocitinib, ruxolitinib, and tofacitinib.

TAKEAWAY:

• The most frequently reported AEs in children were blood and lymphatic system disorders, including neutropenia, thrombocytopenia, and anemia (24%); viral, fungal, and bacterial infections, such as pneumonia and sepsis (17.2%); constitutional symptoms and administrative concerns, including pyrexia and fatigue (15.7%); gastrointestinal disorders, such as vomiting and abdominal pain (13.6%); and respiratory disorders, such as cough and respiratory distress (5.3%).
• In adults, the most common AEs were viral, fungal, and bacterial infections (16.8%); constitutional symptoms and administrative concerns (13.5%); musculoskeletal and connective tissue disorders (7.04%); and gastrointestinal (5.8%) and nervous system (5%) disorders.
• Acne (30.6%), atopic dermatitis (22.2%), and psoriasis (16.7%) were the most common skin and subcutaneous tissue AEs reported in children. Skin and subcutaneous AEs were more common with upadacitinib (21.1%), abrocitinib (9.1%), and tofacitinib (6.3%) in children.
• Serious AEs included in the boxed warning for JAK inhibitors — serious infection, mortality, malignancy, cardiovascular events, and thrombosis — were similar for baricitinib in children (4 of 49 patients, 8.2%) and adults (325 of 3707, 8.8%). For other JAK inhibitors, absolute numbers of these AEs in children were small and rates were lower in children than in adults.

IN PRACTICE:

“This information can support customized treatment and minimize the potential for undesired or intolerable AEs,” the authors wrote.

SOURCE:

This study was led by Sahithi Talasila, BS, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and was published online in Pediatric Dermatology.

LIMITATIONS:

Pharmacovigilance registries did not fully capture the complete range of AEs because of potential reporting bias or recall bias. Additionally, events lacking sufficient objective evidence were underreported, while common AEs associated with JAK inhibitor therapy were overreported.

DISCLOSURES:

No specific funding sources for the study were reported. One author reported being a consultant, one reported serving as a principal investigator in clinical trials, and another reported serving on data and safety monitoring boards of various pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as a subcutaneous injection in adults, covering all approved indications of the intravenous (IV) formulation.

Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.

This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.

“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.

Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.

Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).

No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.

The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.

Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.

The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.

Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.

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

The Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as a subcutaneous injection in adults, covering all approved indications of the intravenous (IV) formulation.

Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.

This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.

“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.

Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.

Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).

No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.

The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.

Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.

The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.

Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.

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

The Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as a subcutaneous injection in adults, covering all approved indications of the intravenous (IV) formulation.

Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.

This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.

“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.

Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.

Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).

No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.

The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.

Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.

The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.

Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Pharmacy closures in the United States are creating “pharmacy deserts,” disproportionately affecting socially vulnerable communities. High social vulnerability and low primary care practitioner (PCP) density are linked to increased pharmacy desert density.

METHODOLOGY:

• Data through 2020 on communities located 10 or more miles from the nearest retail pharmacy were sourced from TelePharm Map.
• Counties were stratified as having a high pharmacy desert density if the number of pharmacy deserts per 1000 inhabitants was in the 80th percentile or higher.
• Social vulnerability index and healthcare practitioner data were obtained from the Agency for Toxic Substances and Disease Registry and the Area Health Resources Files.
• PCP density was calculated as the number of PCPs per 10,000 inhabitants.
• A total of 3143 counties were analyzed, with 1447 (46%) having at least one pharmacy desert.

TAKEAWAY:

• Counties with a high pharmacy desert density had a higher social vulnerability index than those with a low pharmacy desert density (P = .006).
• Areas with a high pharmacy desert density had lower median PCP density than those with low or no pharmacy desert density (P < .001).
• High social vulnerability index (odds ratio [OR], 1.35; 95% CI, 1.07-1.70; P = .01) and low PCP density (OR, 2.27; 95% CI, 1.80-2.86; P < .001) were associated with a higher likelihood for a county to have a high pharmacy desert density.
• Pharmacy closures are leaving more individuals without easy access to medications, with disproportionate consequences for certain communities.

IN PRACTICE:

“As high pharmacy desert density counties also have a lower PCP density, patients residing in these regions face increased barriers to accessing primary healthcare needs,” wrote the authors of the study.

SOURCE:

The study was led by Giovanni Catalano, MD, Muhammad Muntazir Mehdi Khan, MBBS, and Timothy M. Pawlik, MD, PhD, MPH, MTS, MBA, Department of Surgery, The Ohio State University Wexner Medical Center in Columbus, Ohio. It was published online in JAMA Network Open.

LIMITATIONS:

The cross-sectional design of the study limited the ability to draw causal inferences. The study relied on public county-level data, which may not have captured all relevant variables. The use of the social vulnerability index and PCP density as proxies did not fully represent the complexity of pharmacy access issues. The study’s findings were not generalizable to regions outside the United States.

DISCLOSURES:

No relevant conflicts of interest were disclosed by the authors. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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

The University of Virginia (UVA) is defending the CEO of its health system and its medical school dean in the wake of a very public call for their removal.

At least 128 members of the University of Virginia faculty who are employed by both the medical school and the UVA Physicians Group wrote to the UVA Board of Visitors and its peer-elected faculty leaders, expressing no confidence in K. Craig Kent, MD, CEO of UVA Health and executive vice president for health affairs, and Melina Kibbe, MD, dean of the medical school and chief health affairs officer.

Dr. Kibbe, a vascular surgeon and researcher, is also the editor in chief of JAMA Surgery.

“We call for the immediate removal of Craig Kent and Melina Kibbe,” wrote the physicians.

The letter alleged that patient safety was compromised because doctors, nurses, and other staff were pressured to abstain from reporting safety concerns and that physicians had been hired “despite concerns regarding integrity and quality.” Those who raised safety concerns faced “explicit and implicit threats and retaliation,” including delays and denials of promotion and tenure, said the letter.

The September 5 letter did not include signatures. The authors said that names were being protected, but that they would share the names with a limited audience.

UVA President Jim Ryan took issue with the notion that the signees were anonymous. He said in his own letter to medical school faculty that some of the accusations were about matters that had already been addressed or that were being worked on. As far as allegations that he was not previously aware of, “we will do our best to investigate,” he said.

The faculty who signed the letter “have besmirched the reputations of not just Melina and Craig,” wrote Mr. Ryan. “They have unfairly — and I trust unwittingly — cast a shadow over the great work of the entire health system and medical school.”

The authors claimed that reports about bullying and harassment of trainees had been “suppressed, minimized, and subsequently altered.”

And they said that spending on leadership was prioritized over addressing clinical and technical staff shortages. Whistleblowers who reported fraud were not protected, and clinicians were pressured to modify patient records to “obfuscate adverse outcomes and boost productivity metrics,” they wrote.

The 128 members of the UVA Physicians Group who signed the letter represent about 10% of the 1400 medical school faculty members.

It is not the first time that Dr. Kent has been given a vote of no confidence. In 2017, when he was the dean of the College of Medicine at the Ohio State University, Dr. Kent was accused in a “no confidence” letter from 25 physicians and faculty of helping to undermine the school’s mission and taking actions that led to resignations and early retirements of many staff, the Columbus Dispatch reported.

William G. Crutchfield Jr., a member of the UVA Health System Board, defended Dr. Kent and Dr. Kibbe in a lengthy statement shared with this news organization. He said that UVA Health’s four hospitals had received “A” ratings for safety, and that the system has a 5.1% turnover rate compared with a national average of 8.3%.

Dr. Kent and Dr. Kibbe have recruited faculty from top academic medical centers, Mr. Crutchfield wrote.

“If our work environment were so toxic, these people would not have joined our faculty,” he wrote.

Mr. Crutchfield credited Dr. Kent and Dr. Kibbe with crafting a new 10-year strategic plan and for hiring a chief strategy officer to lead the plan — a move that replaced “expensive outside consultants.”

Mr. Ryan said in his letter that his inbox “is overflowing with testimonials from some of the 1200-plus faculty who did not sign the letter, who attest that the health system today — under Melina and Craig’s leadership — is in the best shape it has ever been in, and that they have addressed changes that have needed to be made for more than two decades.”

A request to see some of these positive testimonials was not answered by press time.

Mr. Crutchfield, like Mr. Ryan, said that the letter writers were doing more harm than good.

“If a small cabal of people hiding behind anonymity can force outstanding leaders out of UVA, it will make it extremely difficult to recruit outstanding new physicians, nurses, technicians, and administrators,” he wrote.

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