Congress finally seems ready to take action on the Children’s Health Insurance Program after funding lapsed Sept. 30.

Before the deadline, lawmakers were busy grappling with the failed repeal of the Affordable Care Act.

CHIP covers 9 million children nationwide. But until Congress renews CHIP, states are cut off from additional federal funding that helps lower- and middle-income families.

CHIP, which has enjoyed broad bipartisan support, helps lower- and middle-income families that otherwise earn too much to be eligible for Medicaid. Besides children, it covers 370,000 pregnant women a year. Like Medicaid, CHIP is traditionally paid for with state and federal funds, but the federal government covers most of the cost.

Though current authorization for spending has expired, states can use some of their unspent federal CHIP money. Still, several states are expected to run out of money before the end of 2017, and most of the rest will run out by next summer. CHIP has been in this fix only one other time since it was established in 1997. In 2007, CHIP went weeks without funding authorization from Congress.

Here’s a quick look at what may lie ahead for the program.

1. Will children lose coverage because Congress missed the deadline?

They could eventually, but not immediately. A few states facing the most immediate threat – including California and Arizona – have enough funding to last only until the end of the year.

No states have yet announced plans to freeze enrollment or alert families about any potential end in coverage. But if Congress fails to renew funding quickly, some states may begin taking steps to unwind the program in the next few weeks.

2. What are states doing in reaction to Congress missing the deadline?

Most states are doing little except reaching into their unspent federal funds.

However, Minnesota was among those most imperiled because it had spent all its funds. State officials said Tuesday that the federal Centers for Medicare & Medicaid Services (CMS) was giving Minnesota $3.6 million from unspent national funds to cover CHIP this month.

Emily Piper, commissioner of the Minnesota Department of Human Services, reported in a newspaper commentary in September that her state’s funds would be exhausted by the end of that month.

Even without the last-minute infusion of funding from CMS, most of the children covered by CHIP would have continued to receive care under the state’s Medicaid program, but Minnesota would get fewer federal dollars for each child, according to Piper’s commentary. However, she added, those most at risk are the 1,700 pregnant women covered by CHIP, because they wouldn’t be eligible for Medicaid.

Utah has notified CMS that it plans to discontinue its CHIP program by the end of the year unless it receives more federal money. About 19,000 children are in the state’s CHIP program, state officials say. So far, though, the state said it is not moving to suspend service or enrollment or alert enrollees about any possible changes.

Nevada officials said if funding is not extended it might have to freeze enrollment on Nov. 1 and end coverage by Nov. 30.

California, which has 1.3 million children covered by CHIP, has the highest enrollment of any state running out of funding this year. But, so far, it’s continuing business as usual.

“We estimate that we have available CHIP funding at least through December 2017,” said Tony Cava, spokesman for California Department of Health Services. “Our CHIP program is open for enrollment and continues to operate normally.”

Oregon said it has enough CHIP funding to last through October for its program that covers 98,000 children.
 

3. When is Congress likely to act?

The Senate Finance and the House Energy and Commerce committees have scheduled votes Wednesday on legislation to extend CHIP funding. If both approve their individual bills, floor votes could come quickly, and then both houses would need to resolve any differences.

Senate Finance Committee Chairman Orrin Hatch (R-Utah) and the committee’s ranking Democrat, Sen. Ron Wyden of Oregon, announced an agreement in mid-September to renew CHIP funding. Under the proposed deal, federal CHIP funding would drop by 23 percentage points starting in by 2020, returning to its pre-Affordable Care Act levels. The agreement would extend the life of the CHIP program through 2022.

Hatch and Wyden did not provide any details on how they would pay for the CHIP extension.

The House Energy and Commerce Committee posted its bill just before midnight Monday. It mirrors the Senate Finance plan by extending funding for CHIP for five years and gradually phasing down the 23-percentage-point funding increase provided under Affordable Care Act over the next two years.
 

4. If CHIP is so popular among Republicans and Democrats, why hasn’t Congress renewed the program yet?

The funding renewal was not a priority among Republican leaders, who have spent most of this year trying to replace the Affordable Care Act and dramatically overhaul the Medicaid program. Some in Congress also thought the Sept. 30 deadline was squishy since states could extend their existing funds beyond that.
 

5. Who benefits from CHIP?

While CHIP income eligibility levels vary by state, about 90 percent of children covered are in families earning 200 percent of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. States have the option to cover pregnant women, and 18 plus the District of Columbia do so.

The program is known by different names in different states such as Hoosier Healthwise in Indiana and PeachCare for Kids in Georgia.

For families that move out of Medicaid as their incomes rise, CHIP is an affordable option that ensures continued coverage for their children. Many states operate their CHIP programs as part of Medicaid.

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Congress finally seems ready to take action on the Children’s Health Insurance Program after funding lapsed Sept. 30.

Before the deadline, lawmakers were busy grappling with the failed repeal of the Affordable Care Act.

CHIP covers 9 million children nationwide. But until Congress renews CHIP, states are cut off from additional federal funding that helps lower- and middle-income families.

CHIP, which has enjoyed broad bipartisan support, helps lower- and middle-income families that otherwise earn too much to be eligible for Medicaid. Besides children, it covers 370,000 pregnant women a year. Like Medicaid, CHIP is traditionally paid for with state and federal funds, but the federal government covers most of the cost.

Though current authorization for spending has expired, states can use some of their unspent federal CHIP money. Still, several states are expected to run out of money before the end of 2017, and most of the rest will run out by next summer. CHIP has been in this fix only one other time since it was established in 1997. In 2007, CHIP went weeks without funding authorization from Congress.

Here’s a quick look at what may lie ahead for the program.

1. Will children lose coverage because Congress missed the deadline?

They could eventually, but not immediately. A few states facing the most immediate threat – including California and Arizona – have enough funding to last only until the end of the year.

No states have yet announced plans to freeze enrollment or alert families about any potential end in coverage. But if Congress fails to renew funding quickly, some states may begin taking steps to unwind the program in the next few weeks.

2. What are states doing in reaction to Congress missing the deadline?

Most states are doing little except reaching into their unspent federal funds.

However, Minnesota was among those most imperiled because it had spent all its funds. State officials said Tuesday that the federal Centers for Medicare & Medicaid Services (CMS) was giving Minnesota $3.6 million from unspent national funds to cover CHIP this month.

Emily Piper, commissioner of the Minnesota Department of Human Services, reported in a newspaper commentary in September that her state’s funds would be exhausted by the end of that month.

Even without the last-minute infusion of funding from CMS, most of the children covered by CHIP would have continued to receive care under the state’s Medicaid program, but Minnesota would get fewer federal dollars for each child, according to Piper’s commentary. However, she added, those most at risk are the 1,700 pregnant women covered by CHIP, because they wouldn’t be eligible for Medicaid.

Utah has notified CMS that it plans to discontinue its CHIP program by the end of the year unless it receives more federal money. About 19,000 children are in the state’s CHIP program, state officials say. So far, though, the state said it is not moving to suspend service or enrollment or alert enrollees about any possible changes.

Nevada officials said if funding is not extended it might have to freeze enrollment on Nov. 1 and end coverage by Nov. 30.

California, which has 1.3 million children covered by CHIP, has the highest enrollment of any state running out of funding this year. But, so far, it’s continuing business as usual.

“We estimate that we have available CHIP funding at least through December 2017,” said Tony Cava, spokesman for California Department of Health Services. “Our CHIP program is open for enrollment and continues to operate normally.”

Oregon said it has enough CHIP funding to last through October for its program that covers 98,000 children.
 

3. When is Congress likely to act?

The Senate Finance and the House Energy and Commerce committees have scheduled votes Wednesday on legislation to extend CHIP funding. If both approve their individual bills, floor votes could come quickly, and then both houses would need to resolve any differences.

Senate Finance Committee Chairman Orrin Hatch (R-Utah) and the committee’s ranking Democrat, Sen. Ron Wyden of Oregon, announced an agreement in mid-September to renew CHIP funding. Under the proposed deal, federal CHIP funding would drop by 23 percentage points starting in by 2020, returning to its pre-Affordable Care Act levels. The agreement would extend the life of the CHIP program through 2022.

Hatch and Wyden did not provide any details on how they would pay for the CHIP extension.

The House Energy and Commerce Committee posted its bill just before midnight Monday. It mirrors the Senate Finance plan by extending funding for CHIP for five years and gradually phasing down the 23-percentage-point funding increase provided under Affordable Care Act over the next two years.
 

4. If CHIP is so popular among Republicans and Democrats, why hasn’t Congress renewed the program yet?

The funding renewal was not a priority among Republican leaders, who have spent most of this year trying to replace the Affordable Care Act and dramatically overhaul the Medicaid program. Some in Congress also thought the Sept. 30 deadline was squishy since states could extend their existing funds beyond that.
 

5. Who benefits from CHIP?

While CHIP income eligibility levels vary by state, about 90 percent of children covered are in families earning 200 percent of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. States have the option to cover pregnant women, and 18 plus the District of Columbia do so.

The program is known by different names in different states such as Hoosier Healthwise in Indiana and PeachCare for Kids in Georgia.

For families that move out of Medicaid as their incomes rise, CHIP is an affordable option that ensures continued coverage for their children. Many states operate their CHIP programs as part of Medicaid.

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Congress finally seems ready to take action on the Children’s Health Insurance Program after funding lapsed Sept. 30.

Before the deadline, lawmakers were busy grappling with the failed repeal of the Affordable Care Act.

CHIP covers 9 million children nationwide. But until Congress renews CHIP, states are cut off from additional federal funding that helps lower- and middle-income families.

CHIP, which has enjoyed broad bipartisan support, helps lower- and middle-income families that otherwise earn too much to be eligible for Medicaid. Besides children, it covers 370,000 pregnant women a year. Like Medicaid, CHIP is traditionally paid for with state and federal funds, but the federal government covers most of the cost.

Though current authorization for spending has expired, states can use some of their unspent federal CHIP money. Still, several states are expected to run out of money before the end of 2017, and most of the rest will run out by next summer. CHIP has been in this fix only one other time since it was established in 1997. In 2007, CHIP went weeks without funding authorization from Congress.

Here’s a quick look at what may lie ahead for the program.

1. Will children lose coverage because Congress missed the deadline?

They could eventually, but not immediately. A few states facing the most immediate threat – including California and Arizona – have enough funding to last only until the end of the year.

No states have yet announced plans to freeze enrollment or alert families about any potential end in coverage. But if Congress fails to renew funding quickly, some states may begin taking steps to unwind the program in the next few weeks.

2. What are states doing in reaction to Congress missing the deadline?

Most states are doing little except reaching into their unspent federal funds.

However, Minnesota was among those most imperiled because it had spent all its funds. State officials said Tuesday that the federal Centers for Medicare & Medicaid Services (CMS) was giving Minnesota $3.6 million from unspent national funds to cover CHIP this month.

Emily Piper, commissioner of the Minnesota Department of Human Services, reported in a newspaper commentary in September that her state’s funds would be exhausted by the end of that month.

Even without the last-minute infusion of funding from CMS, most of the children covered by CHIP would have continued to receive care under the state’s Medicaid program, but Minnesota would get fewer federal dollars for each child, according to Piper’s commentary. However, she added, those most at risk are the 1,700 pregnant women covered by CHIP, because they wouldn’t be eligible for Medicaid.

Utah has notified CMS that it plans to discontinue its CHIP program by the end of the year unless it receives more federal money. About 19,000 children are in the state’s CHIP program, state officials say. So far, though, the state said it is not moving to suspend service or enrollment or alert enrollees about any possible changes.

Nevada officials said if funding is not extended it might have to freeze enrollment on Nov. 1 and end coverage by Nov. 30.

California, which has 1.3 million children covered by CHIP, has the highest enrollment of any state running out of funding this year. But, so far, it’s continuing business as usual.

“We estimate that we have available CHIP funding at least through December 2017,” said Tony Cava, spokesman for California Department of Health Services. “Our CHIP program is open for enrollment and continues to operate normally.”

Oregon said it has enough CHIP funding to last through October for its program that covers 98,000 children.
 

3. When is Congress likely to act?

The Senate Finance and the House Energy and Commerce committees have scheduled votes Wednesday on legislation to extend CHIP funding. If both approve their individual bills, floor votes could come quickly, and then both houses would need to resolve any differences.

Senate Finance Committee Chairman Orrin Hatch (R-Utah) and the committee’s ranking Democrat, Sen. Ron Wyden of Oregon, announced an agreement in mid-September to renew CHIP funding. Under the proposed deal, federal CHIP funding would drop by 23 percentage points starting in by 2020, returning to its pre-Affordable Care Act levels. The agreement would extend the life of the CHIP program through 2022.

Hatch and Wyden did not provide any details on how they would pay for the CHIP extension.

The House Energy and Commerce Committee posted its bill just before midnight Monday. It mirrors the Senate Finance plan by extending funding for CHIP for five years and gradually phasing down the 23-percentage-point funding increase provided under Affordable Care Act over the next two years.
 

4. If CHIP is so popular among Republicans and Democrats, why hasn’t Congress renewed the program yet?

The funding renewal was not a priority among Republican leaders, who have spent most of this year trying to replace the Affordable Care Act and dramatically overhaul the Medicaid program. Some in Congress also thought the Sept. 30 deadline was squishy since states could extend their existing funds beyond that.
 

5. Who benefits from CHIP?

While CHIP income eligibility levels vary by state, about 90 percent of children covered are in families earning 200 percent of poverty or less ($40,840 for a family of three). CHIP covers children up to age 19. States have the option to cover pregnant women, and 18 plus the District of Columbia do so.

The program is known by different names in different states such as Hoosier Healthwise in Indiana and PeachCare for Kids in Georgia.

For families that move out of Medicaid as their incomes rise, CHIP is an affordable option that ensures continued coverage for their children. Many states operate their CHIP programs as part of Medicaid.

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation.
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

JARRELL, Texas – Darrell Kenyon had been punting for years on various medical issues – fatigue, headaches, mood swings. The 43-year-old uninsured carpenter was particularly worried about his blood pressure, which ran high when he checked it at the grocery store. Then he heard about a different type of physician practice, one that provided regular primary care for a monthly fee.

“Insurance for the self-employed is through the roof,” Mr. Kenyon told Loy Graham, MD, as she examined him one morning in August. Two years ago, Dr. Graham had hung out her shingle in this central Texas town of nearly 1,400, about 40 miles north of Austin.

Under the practice model, called direct primary care, patients are charged monthly – typically $20-$75, depending on age, in Dr. Graham’s practice – for basic, office-based medical care and frequently cell phone and other after-hours physician access. Proponents of the model, which is also supported as a practice option by the American Academy of Family Physicians, say it can provide a safety net for those with limited treatment options, including the uninsured and people in the country illegally. The alternative is particularly helpful in states like Texas that haven’t expanded Medicaid access, the advocates add.

But there’s a sizable catch: Direct primary care is not insurance.

Carolyn Engelhard worries that strapped individuals will decide the easier access to primary care is “good enough” and won’t investigate insurance options. “It can be a false security,” said Ms. Engelhard, who directs the health policy program at the University of Virginia, Charlottesville. “There’s sort of the illusion that it’s kind of like insurance.”

Lower-income Texans would be better off with coverage on the Affordable Care Act’s insurance exchange, where they could get a subsidy to reduce the cost of their premiums, Ms. Engelhard said. The policy would have a deductible, “which they might feel that they can’t afford,” she said. “But they would be protected if they got cancer or if they had an automobile accident.”

Dr. Graham estimates that at least three-quarters of her roughly 450 patients lack insurance, even though she advises them to carry some kind of catastrophic coverage for major health expenses. But the cost for such policies can be daunting. Like Mr. Kenyon, some of Dr. Graham’s patients are self-employed with fluctuating incomes or work for businesses that don’t offer coverage. Even if their employer offers affordable coverage for the employee, premiums for dependents might make coverage financially out of reach. Roughly 1 in 5 of her patients speak primarily Spanish. Some are undocumented, working in construction and other labor-intensive jobs in the region.

Despite her concerns, Ms. Engelhard said, such flat-fee practices might offer “one of the few viable options” for those living here under the radar, given they’re not eligible for ACA-related coverage. “So they are completely dependent on paying out-of-pocket for medical care,” she said.
 

‘Better than nothing’?

Nationally, direct primary care is relatively new and very much a niche option. Nearly 3% of family physicians practice it, according to a 2017 survey by the American Academy of Family Physicians. Some critics have questioned whether the model’s growth is already stalling, after one of its earliest providers, Seattle-based Qliance, closed its clinics this year.

Dr. Graham, who practiced traditional medicine in Central Texas for decades, said she was drawn to the option after growing weary of packing too many patients into each day. She was considering leaving medicine and had started developing a lavender farm as an alternative source of income when she heard about direct primary care.

In 2015, she opened her practice in a small strip mall in Jarrell, figuring that nearby residents – with limited access to primary care – might take a chance on the different style of medicine.

John Bender, MD, an academy board member who is part of a larger practice that’s transitioning to direct primary care, said that the low monthly fees are attracting patients who view insurance as out of reach. “I think something [in terms of medical care] is better than nothing,” said the Fort Collins, Colo., family physician, who estimates that roughly half of the practice’s 800-plus direct primary care patients are uninsured.

“I can spare them quite a few urgent care and emergency room bills,” Dr. Bender said, noting that his office handles anything from strep throat to stitches for minor gashes. Moreover, the cost is within reach of people on tight budgets, he said. “In fact, a carton of cigarettes runs $49, which just happens to be the price of my monthly subscription fee [for adults].”

In Texas, 16.6% of the state’s residents were uninsured as of 2016, the highest rate nationally, according to the most recent Census Bureau data. The Lone Star State didn’t expand Medicaid access and has one of the nation’s lowest income-eligibility cutoffs. A single mother with two children can’t earn more than $3,781 annually to qualify for coverage herself, according to a 2017 Medicaid report by the Center for Public Policy Priorities, an Austin-based nonprofit research and advocacy organization.

Felicia Macik, DO, who launched her direct care practice in 2014 in Waco, estimates that 10%-15% of her patients are uninsured, including some who drop coverage because they can’t afford the premiums. “I’m frightened for them,” she said. “It could decimate a family if something happened and they didn’t have any coverage.”

But Dr. Macik pointed out that getting regular primary care, rather than avoiding the doctor entirely due to lack of insurance, might avert costlier complications like an asthma attack or a diabetic crisis.

Uninsured individuals who sign up for these practices are rolling the dice, said Mohan Nadkarni, MD, an internist who cofounded the Charlottesville (Va.) Free Clinic, which treats lower-income individuals. “For routine regular care, it may work out,” he said. “But it’s gambling that you’re not going to get sicker and need further care.”

For instance, a patient can develop severe heartburn and require further tests and referrals to specialists to look for the underlying cause – potentially anything from an ulcer to esophageal cancer – that could quickly run up a hefty bill, Dr. Nadkarni said. Another patient with chest pain might need a similarly costly work-up to rule out heart problems, including a potentially life-threatening blockage, he said.

Dr. Graham said that her monthly fees cover anything that she can handle in the office. During Mr. Kenyon’s visit, she froze a small growth off one ear. Shortly afterward, she gave a steroid injection to an older woman with a painful, swollen wrist.

She has negotiated low fees with a local laboratory; the battery of blood tests and urinalysis she ordered for Mr. Kenyon cost him just under $40. “This is concierge medicine for normal people,” said the 61-year-old family physician.

Physician enthusiasts maintain that jettisoning the paperwork and other overhead costs associated with insurance enables them to take on fewer patients – roughly 600-800 for direct care practices compared with 2,000-2,500 typically, according to the family physicians academy – and thus spend more time with each one.
 

As a safety net, it’s a stretch

Erika Miller first came to see Dr. Graham 2 years ago for severe headaches. The 30-year-old mother of three, who is working on her college degree and has a full-time job, doesn’t have insurance.

Dr. Graham diagnosed high blood pressure. Getting that under control helped alleviate her headaches, Ms. Miller said. She also has shed 50 pounds under Dr. Graham’s guidance.

But Dr. Graham can’t handle everything for her patients. Last year, Ms. Miller went to the emergency room at Scott & White Medical Center in nearby Temple with severe abdominal pain. It was her appendix, which had to be removed. The safety-net hospital started Ms. Miller on a payment plan based on her income, totaling roughly $500.

“If the question is: ‘Is [direct primary care] better than nothing?’ Then I would say, ‘Yes,’ ” Ms. Engelhard said. But along with leaving uninsured patients financially vulnerable to a medical curveball, she said, these smaller practices – by seeing fewer patients per doctor – risk aggravating the nation’s primary care shortage if they become more common.

Dr. Graham countered that she nearly left medicine, but these days – as she continues to build her practice – she’s reaching some patients who had previously fallen through the health system’s cracks. On that summer morning, Mr. Kenyon left Dr. Graham’s office with a prescription for a blood pressure medication and an appointment to return in several weeks to discuss his lab results.

Mr. Kenyon and his wife, Denise, later described how they had signed up last year for a family policy through the Affordable Care Act. But the monthly premium was $750 and the deductibles were $3,500 per person, Denise Kenyon said.

She called around and couldn’t find a family doctor who would take the coverage. After several months, they stopped paying the premiums, figuring that the money they saved would pay for a lot of medical care.

Both are now patients of Dr. Graham’s; their combined monthly bill totals $125, which they can budget for, Darrell Kenyon said. “I do have good months and bad months, as far as pay is concerned,” he said. “If I have a bad month, it’s still affordable.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

JARRELL, Texas – Darrell Kenyon had been punting for years on various medical issues – fatigue, headaches, mood swings. The 43-year-old uninsured carpenter was particularly worried about his blood pressure, which ran high when he checked it at the grocery store. Then he heard about a different type of physician practice, one that provided regular primary care for a monthly fee.

“Insurance for the self-employed is through the roof,” Mr. Kenyon told Loy Graham, MD, as she examined him one morning in August. Two years ago, Dr. Graham had hung out her shingle in this central Texas town of nearly 1,400, about 40 miles north of Austin.

Under the practice model, called direct primary care, patients are charged monthly – typically $20-$75, depending on age, in Dr. Graham’s practice – for basic, office-based medical care and frequently cell phone and other after-hours physician access. Proponents of the model, which is also supported as a practice option by the American Academy of Family Physicians, say it can provide a safety net for those with limited treatment options, including the uninsured and people in the country illegally. The alternative is particularly helpful in states like Texas that haven’t expanded Medicaid access, the advocates add.

But there’s a sizable catch: Direct primary care is not insurance.

Carolyn Engelhard worries that strapped individuals will decide the easier access to primary care is “good enough” and won’t investigate insurance options. “It can be a false security,” said Ms. Engelhard, who directs the health policy program at the University of Virginia, Charlottesville. “There’s sort of the illusion that it’s kind of like insurance.”

Lower-income Texans would be better off with coverage on the Affordable Care Act’s insurance exchange, where they could get a subsidy to reduce the cost of their premiums, Ms. Engelhard said. The policy would have a deductible, “which they might feel that they can’t afford,” she said. “But they would be protected if they got cancer or if they had an automobile accident.”

Dr. Graham estimates that at least three-quarters of her roughly 450 patients lack insurance, even though she advises them to carry some kind of catastrophic coverage for major health expenses. But the cost for such policies can be daunting. Like Mr. Kenyon, some of Dr. Graham’s patients are self-employed with fluctuating incomes or work for businesses that don’t offer coverage. Even if their employer offers affordable coverage for the employee, premiums for dependents might make coverage financially out of reach. Roughly 1 in 5 of her patients speak primarily Spanish. Some are undocumented, working in construction and other labor-intensive jobs in the region.

Despite her concerns, Ms. Engelhard said, such flat-fee practices might offer “one of the few viable options” for those living here under the radar, given they’re not eligible for ACA-related coverage. “So they are completely dependent on paying out-of-pocket for medical care,” she said.
 

‘Better than nothing’?

Nationally, direct primary care is relatively new and very much a niche option. Nearly 3% of family physicians practice it, according to a 2017 survey by the American Academy of Family Physicians. Some critics have questioned whether the model’s growth is already stalling, after one of its earliest providers, Seattle-based Qliance, closed its clinics this year.

Dr. Graham, who practiced traditional medicine in Central Texas for decades, said she was drawn to the option after growing weary of packing too many patients into each day. She was considering leaving medicine and had started developing a lavender farm as an alternative source of income when she heard about direct primary care.

In 2015, she opened her practice in a small strip mall in Jarrell, figuring that nearby residents – with limited access to primary care – might take a chance on the different style of medicine.

John Bender, MD, an academy board member who is part of a larger practice that’s transitioning to direct primary care, said that the low monthly fees are attracting patients who view insurance as out of reach. “I think something [in terms of medical care] is better than nothing,” said the Fort Collins, Colo., family physician, who estimates that roughly half of the practice’s 800-plus direct primary care patients are uninsured.

“I can spare them quite a few urgent care and emergency room bills,” Dr. Bender said, noting that his office handles anything from strep throat to stitches for minor gashes. Moreover, the cost is within reach of people on tight budgets, he said. “In fact, a carton of cigarettes runs $49, which just happens to be the price of my monthly subscription fee [for adults].”

In Texas, 16.6% of the state’s residents were uninsured as of 2016, the highest rate nationally, according to the most recent Census Bureau data. The Lone Star State didn’t expand Medicaid access and has one of the nation’s lowest income-eligibility cutoffs. A single mother with two children can’t earn more than $3,781 annually to qualify for coverage herself, according to a 2017 Medicaid report by the Center for Public Policy Priorities, an Austin-based nonprofit research and advocacy organization.

Felicia Macik, DO, who launched her direct care practice in 2014 in Waco, estimates that 10%-15% of her patients are uninsured, including some who drop coverage because they can’t afford the premiums. “I’m frightened for them,” she said. “It could decimate a family if something happened and they didn’t have any coverage.”

But Dr. Macik pointed out that getting regular primary care, rather than avoiding the doctor entirely due to lack of insurance, might avert costlier complications like an asthma attack or a diabetic crisis.

Uninsured individuals who sign up for these practices are rolling the dice, said Mohan Nadkarni, MD, an internist who cofounded the Charlottesville (Va.) Free Clinic, which treats lower-income individuals. “For routine regular care, it may work out,” he said. “But it’s gambling that you’re not going to get sicker and need further care.”

For instance, a patient can develop severe heartburn and require further tests and referrals to specialists to look for the underlying cause – potentially anything from an ulcer to esophageal cancer – that could quickly run up a hefty bill, Dr. Nadkarni said. Another patient with chest pain might need a similarly costly work-up to rule out heart problems, including a potentially life-threatening blockage, he said.

Dr. Graham said that her monthly fees cover anything that she can handle in the office. During Mr. Kenyon’s visit, she froze a small growth off one ear. Shortly afterward, she gave a steroid injection to an older woman with a painful, swollen wrist.

She has negotiated low fees with a local laboratory; the battery of blood tests and urinalysis she ordered for Mr. Kenyon cost him just under $40. “This is concierge medicine for normal people,” said the 61-year-old family physician.

Physician enthusiasts maintain that jettisoning the paperwork and other overhead costs associated with insurance enables them to take on fewer patients – roughly 600-800 for direct care practices compared with 2,000-2,500 typically, according to the family physicians academy – and thus spend more time with each one.
 

As a safety net, it’s a stretch

Erika Miller first came to see Dr. Graham 2 years ago for severe headaches. The 30-year-old mother of three, who is working on her college degree and has a full-time job, doesn’t have insurance.

Dr. Graham diagnosed high blood pressure. Getting that under control helped alleviate her headaches, Ms. Miller said. She also has shed 50 pounds under Dr. Graham’s guidance.

But Dr. Graham can’t handle everything for her patients. Last year, Ms. Miller went to the emergency room at Scott & White Medical Center in nearby Temple with severe abdominal pain. It was her appendix, which had to be removed. The safety-net hospital started Ms. Miller on a payment plan based on her income, totaling roughly $500.

“If the question is: ‘Is [direct primary care] better than nothing?’ Then I would say, ‘Yes,’ ” Ms. Engelhard said. But along with leaving uninsured patients financially vulnerable to a medical curveball, she said, these smaller practices – by seeing fewer patients per doctor – risk aggravating the nation’s primary care shortage if they become more common.

Dr. Graham countered that she nearly left medicine, but these days – as she continues to build her practice – she’s reaching some patients who had previously fallen through the health system’s cracks. On that summer morning, Mr. Kenyon left Dr. Graham’s office with a prescription for a blood pressure medication and an appointment to return in several weeks to discuss his lab results.

Mr. Kenyon and his wife, Denise, later described how they had signed up last year for a family policy through the Affordable Care Act. But the monthly premium was $750 and the deductibles were $3,500 per person, Denise Kenyon said.

She called around and couldn’t find a family doctor who would take the coverage. After several months, they stopped paying the premiums, figuring that the money they saved would pay for a lot of medical care.

Both are now patients of Dr. Graham’s; their combined monthly bill totals $125, which they can budget for, Darrell Kenyon said. “I do have good months and bad months, as far as pay is concerned,” he said. “If I have a bad month, it’s still affordable.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

JARRELL, Texas – Darrell Kenyon had been punting for years on various medical issues – fatigue, headaches, mood swings. The 43-year-old uninsured carpenter was particularly worried about his blood pressure, which ran high when he checked it at the grocery store. Then he heard about a different type of physician practice, one that provided regular primary care for a monthly fee.

“Insurance for the self-employed is through the roof,” Mr. Kenyon told Loy Graham, MD, as she examined him one morning in August. Two years ago, Dr. Graham had hung out her shingle in this central Texas town of nearly 1,400, about 40 miles north of Austin.

Under the practice model, called direct primary care, patients are charged monthly – typically $20-$75, depending on age, in Dr. Graham’s practice – for basic, office-based medical care and frequently cell phone and other after-hours physician access. Proponents of the model, which is also supported as a practice option by the American Academy of Family Physicians, say it can provide a safety net for those with limited treatment options, including the uninsured and people in the country illegally. The alternative is particularly helpful in states like Texas that haven’t expanded Medicaid access, the advocates add.

But there’s a sizable catch: Direct primary care is not insurance.

Carolyn Engelhard worries that strapped individuals will decide the easier access to primary care is “good enough” and won’t investigate insurance options. “It can be a false security,” said Ms. Engelhard, who directs the health policy program at the University of Virginia, Charlottesville. “There’s sort of the illusion that it’s kind of like insurance.”

Lower-income Texans would be better off with coverage on the Affordable Care Act’s insurance exchange, where they could get a subsidy to reduce the cost of their premiums, Ms. Engelhard said. The policy would have a deductible, “which they might feel that they can’t afford,” she said. “But they would be protected if they got cancer or if they had an automobile accident.”

Dr. Graham estimates that at least three-quarters of her roughly 450 patients lack insurance, even though she advises them to carry some kind of catastrophic coverage for major health expenses. But the cost for such policies can be daunting. Like Mr. Kenyon, some of Dr. Graham’s patients are self-employed with fluctuating incomes or work for businesses that don’t offer coverage. Even if their employer offers affordable coverage for the employee, premiums for dependents might make coverage financially out of reach. Roughly 1 in 5 of her patients speak primarily Spanish. Some are undocumented, working in construction and other labor-intensive jobs in the region.

Despite her concerns, Ms. Engelhard said, such flat-fee practices might offer “one of the few viable options” for those living here under the radar, given they’re not eligible for ACA-related coverage. “So they are completely dependent on paying out-of-pocket for medical care,” she said.
 

‘Better than nothing’?

Nationally, direct primary care is relatively new and very much a niche option. Nearly 3% of family physicians practice it, according to a 2017 survey by the American Academy of Family Physicians. Some critics have questioned whether the model’s growth is already stalling, after one of its earliest providers, Seattle-based Qliance, closed its clinics this year.

Dr. Graham, who practiced traditional medicine in Central Texas for decades, said she was drawn to the option after growing weary of packing too many patients into each day. She was considering leaving medicine and had started developing a lavender farm as an alternative source of income when she heard about direct primary care.

In 2015, she opened her practice in a small strip mall in Jarrell, figuring that nearby residents – with limited access to primary care – might take a chance on the different style of medicine.

John Bender, MD, an academy board member who is part of a larger practice that’s transitioning to direct primary care, said that the low monthly fees are attracting patients who view insurance as out of reach. “I think something [in terms of medical care] is better than nothing,” said the Fort Collins, Colo., family physician, who estimates that roughly half of the practice’s 800-plus direct primary care patients are uninsured.

“I can spare them quite a few urgent care and emergency room bills,” Dr. Bender said, noting that his office handles anything from strep throat to stitches for minor gashes. Moreover, the cost is within reach of people on tight budgets, he said. “In fact, a carton of cigarettes runs $49, which just happens to be the price of my monthly subscription fee [for adults].”

In Texas, 16.6% of the state’s residents were uninsured as of 2016, the highest rate nationally, according to the most recent Census Bureau data. The Lone Star State didn’t expand Medicaid access and has one of the nation’s lowest income-eligibility cutoffs. A single mother with two children can’t earn more than $3,781 annually to qualify for coverage herself, according to a 2017 Medicaid report by the Center for Public Policy Priorities, an Austin-based nonprofit research and advocacy organization.

Felicia Macik, DO, who launched her direct care practice in 2014 in Waco, estimates that 10%-15% of her patients are uninsured, including some who drop coverage because they can’t afford the premiums. “I’m frightened for them,” she said. “It could decimate a family if something happened and they didn’t have any coverage.”

But Dr. Macik pointed out that getting regular primary care, rather than avoiding the doctor entirely due to lack of insurance, might avert costlier complications like an asthma attack or a diabetic crisis.

Uninsured individuals who sign up for these practices are rolling the dice, said Mohan Nadkarni, MD, an internist who cofounded the Charlottesville (Va.) Free Clinic, which treats lower-income individuals. “For routine regular care, it may work out,” he said. “But it’s gambling that you’re not going to get sicker and need further care.”

For instance, a patient can develop severe heartburn and require further tests and referrals to specialists to look for the underlying cause – potentially anything from an ulcer to esophageal cancer – that could quickly run up a hefty bill, Dr. Nadkarni said. Another patient with chest pain might need a similarly costly work-up to rule out heart problems, including a potentially life-threatening blockage, he said.

Dr. Graham said that her monthly fees cover anything that she can handle in the office. During Mr. Kenyon’s visit, she froze a small growth off one ear. Shortly afterward, she gave a steroid injection to an older woman with a painful, swollen wrist.

She has negotiated low fees with a local laboratory; the battery of blood tests and urinalysis she ordered for Mr. Kenyon cost him just under $40. “This is concierge medicine for normal people,” said the 61-year-old family physician.

Physician enthusiasts maintain that jettisoning the paperwork and other overhead costs associated with insurance enables them to take on fewer patients – roughly 600-800 for direct care practices compared with 2,000-2,500 typically, according to the family physicians academy – and thus spend more time with each one.
 

As a safety net, it’s a stretch

Erika Miller first came to see Dr. Graham 2 years ago for severe headaches. The 30-year-old mother of three, who is working on her college degree and has a full-time job, doesn’t have insurance.

Dr. Graham diagnosed high blood pressure. Getting that under control helped alleviate her headaches, Ms. Miller said. She also has shed 50 pounds under Dr. Graham’s guidance.

But Dr. Graham can’t handle everything for her patients. Last year, Ms. Miller went to the emergency room at Scott & White Medical Center in nearby Temple with severe abdominal pain. It was her appendix, which had to be removed. The safety-net hospital started Ms. Miller on a payment plan based on her income, totaling roughly $500.

“If the question is: ‘Is [direct primary care] better than nothing?’ Then I would say, ‘Yes,’ ” Ms. Engelhard said. But along with leaving uninsured patients financially vulnerable to a medical curveball, she said, these smaller practices – by seeing fewer patients per doctor – risk aggravating the nation’s primary care shortage if they become more common.

Dr. Graham countered that she nearly left medicine, but these days – as she continues to build her practice – she’s reaching some patients who had previously fallen through the health system’s cracks. On that summer morning, Mr. Kenyon left Dr. Graham’s office with a prescription for a blood pressure medication and an appointment to return in several weeks to discuss his lab results.

Mr. Kenyon and his wife, Denise, later described how they had signed up last year for a family policy through the Affordable Care Act. But the monthly premium was $750 and the deductibles were $3,500 per person, Denise Kenyon said.

She called around and couldn’t find a family doctor who would take the coverage. After several months, they stopped paying the premiums, figuring that the money they saved would pay for a lot of medical care.

Both are now patients of Dr. Graham’s; their combined monthly bill totals $125, which they can budget for, Darrell Kenyon said. “I do have good months and bad months, as far as pay is concerned,” he said. “If I have a bad month, it’s still affordable.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

In 1964, Sweet¹ described 8 women with acute onset of fever and erythematous plaques associated with a nonspecific infection of the respiratory or gastrointestinal tract. The lesions were histologically characterized by a neutrophilic infiltrate, and the author named the constellation of findings acute febrile neutrophilic dermatosis.¹ In 1968, Whittle et al² reported on similar cases and coined the term Sweet syndrome (SS).

Although the etiology and pathogenesis of SS remain unknown, several theories have been proposed. Because SS often is preceded by a respiratory or gastrointestinal tract infection, it has been postulated that it may represent a hypersensitivity reaction or may be related to local or systemic dysregulation of cytokine secretion.^3,4 In addition to respiratory or gastrointestinal tract infections, SS has been reported in association with malignancies, autoimmune diseases, drugs, vaccines, pregnancy, inflammatory bowel disease, and chemotherapy. It also may be idiopathic.⁵

The eruption of SS manifests as erythematous, indurated, and sharply demarcated plaques or nodules that typically favor the head, neck, and arms, with a particularly strong predilection for the dorsal aspects of the hands.⁶ Plaques and nodules are histologically characterized by a diffuse dermal neutrophilic infiltrate, papillary dermal edema, neutrophilic spongiosis, subcorneal pustules, and leukocytoclasia. Vasculitic features are not seen.⁷ The eruption typically resolves spontaneously in 5 to 12 weeks but recurs in approximately 30% of cases.⁸ Relatively common extracutaneous findings include ocular involvement, arthralgia, myalgia, and arthritis.^4,9 Both cutaneous and extracutaneous findings typically are responsive to prednisone at a dosage of 0.5 to 1 mg/kg daily for 4 to 6 weeks. Prolonged low-dose prednisone for 2 to 3 additional months may be necessary to suppress recurrence.⁸ Potassium iodide at 900 mg daily may be used as an alternative regimen.^3,8

Sweet syndrome is divided into 5 subcategories based on the underlying etiology: (1) classic or idiopathic, (2) paraneoplastic, (3) inflammatory and/or autoimmune disease related, (4) pregnancy related, and (5) drug induced.³ Although drug-induced SS comprises the minority of total cases (<5%), its reported incidence has been rising in recent years and has been associated with an escalating number of medications.¹⁰ We report a rare case of SS induced by administration of oral acetaminophen-codeine.

Case Report

A 32-year-old man with a history of diabetes mellitus underwent postoperative repair of a facial fracture. The patient was administered an oral acetaminophen-codeine suspension for postoperative pain control. One week later, he developed a painful eruption on the forehead and presented to the emergency department. He was prescribed acetaminophen-codeine 300/30-mg tablets every 6 hours in addition to hydrocortisone cream 1% applied every 6 hours. After this reintroduction of oral acetaminophen-codeine, he experienced intermittent fevers and an exacerbation of the initial cutaneous eruption. The patient presented for a second time 2 days after being seen in the emergency department and a dermatology consultation was obtained.

At the time of consultation, the patient was noted to have injected conjunctiva and erythematous, well-demarcated, and indurated plaques on the forehead with associated pain and burning (Figures 1A and 1B). Additional erythematous annular plaques were found on the palms, arms, and right knee. Laboratory workup revealed only mild anemia on complete blood cell count with a white blood cell count of 10.1×10⁹/L (reference range, 4.5–11.0×10⁹/L), hemoglobin of 12.9 g/dL (reference range, 14.0–17.4 g/dL), and hematocrit of 37.3% (reference range, 41%–50%). The platelet count was 284×10³/µL (reference range, 150–350×10³/µL). Basic metabolic panel was notable for an elevated glucose level of 418 mg/dL (reference range, 70–110 mg/dL). The most recent hemoglobin A_1C (several months prior) was notable at 14.7% of total hemoglobin (reference range, 4%–7% of total hemoglobin). A 4-mm punch biopsy of the right side of the forehead demonstrated minimal to mild papillary dermal edema and a diffuse dermal neutrophilic infiltrate spanning the upper, middle, and lower dermis with evidence of mild leukocytoclasia and no evidence of leukocytoclastic vasculitis (Figure 2). These histologic features together with the clinical presentation were consistent with a diagnosis of SS.

After an initial dose of intravenous methylprednisolone sodium succinate 125 mg in the emergency department, the patient was admitted for additional intravenous steroid administration in the context of uncontrolled hyperglycemia and history of poor glucose control. Upon admission, acetaminophen-codeine was discontinued and the patient was transitioned to intravenous methylprednisolone sodium succinate 60 mg every 8 hours. The patient also was given intravenous diphenhydramine 25 mg every 6 hours and desonide ointment 0.05% was applied to facial lesions. The inpatient medication regimen resulted in notable improvement of symptoms within 48 hours. Due to rapid improvement with steroids, no special stains for infectious etiologies were performed. The patient was discharged after 3 days in the hospital with triamcinolone ointment 0.1% to be applied to affected areas twice daily. The patient experienced no recurrence 2 months after treatment (Figure 1C).

Comment

Although SS itself is relatively rare, there has been an increasing incidence of the drug-induced subtype, most often in association with use of granulocyte colony-stimulating factor and granulocyte monocyte-stimulating factor. There also have been reported associations with a growing number of medications that include antibiotics, antiepileptic drugs, furosemide, hydralazine, and all-trans retinoic acid.^11-19 Moghimi et al¹¹ also reported an association with antivirals, cancer biotherapies, nonsteroidal anti-inflammatory drugs, psychotropes, azathioprine, oral contraceptives, and propylthiouracil.^10,20-26 Moghimi et al¹¹ further reported an association with several vaccines.

Several therapies for advanced melanoma also have been reviewed in the literature, including ipilimumab and vemurafenib,^27-30 as have several medications for the treatment of myelodysplastic syndrome including azacitidine.^31,32 A severe episode of drug-induced SS, predominantly on the legs, has been reported in association with lenalidomide, an immunomodulatory agent used in the treatment of myelodysplastic syndrome.³³

Additional medications more recently involved in the pathogenesis of drug-induced SS include the chemotherapeutic agents topetecan, mitoxantrone, gemcitabine, and vorinostat.^34-37 The antimalarial medication chloroquine also has been implicated, as have selective cyclooxygenase-2 inhibitors, hypomethylating agents, the tumor necrosis factor inhibitor adalimumab, IL-2 therapies, aripiprazole, and several other medications.^38-49

Despite drug-induced SS being reported in association with an increasing number of medications, there had been a lack of appropriate diagnostic criteria. To that end, Walker and Cohen⁵⁰ proposed 5 specific diagnostic criteria in 1996, including abrupt onset of painful erythematous plaques or nodules, histopathologic evidence of a dense neutrophilic infiltrate without evidence of leukocytoclastic vasculitis, pyrexia (temperature >38°C), temporal relationship between drug ingestion and clinical presentation or temporally related recurrence after oral rechallenge, and temporally related resolution of lesions after drug withdrawal or treatment with systemic corticosteroids.^50,51 Our patient met all of these criteria.

Conclusion

The number of cases of drug-induced SS in the literature continues to climb; however, the association with acetaminophen-codeine is unique. The importance of this case lies in educating both physicians and pharmacists alike regarding a newly recognized adverse effect of acetaminophen-codeine. Because acetaminophen-codeine often is used for its analgesic properties, and the predominant symptom of the cutaneous eruption of SS is pain, the therapeutic value of acetaminophen-codeine is substantially diminished in acetaminophen-codeine–induced SS. Accordingly, in these cases, the medication may be discontinued or substituted upon recognition of this adverse reaction to reduce patient morbidity.

In 1964, Sweet¹ described 8 women with acute onset of fever and erythematous plaques associated with a nonspecific infection of the respiratory or gastrointestinal tract. The lesions were histologically characterized by a neutrophilic infiltrate, and the author named the constellation of findings acute febrile neutrophilic dermatosis.¹ In 1968, Whittle et al² reported on similar cases and coined the term Sweet syndrome (SS).

Although the etiology and pathogenesis of SS remain unknown, several theories have been proposed. Because SS often is preceded by a respiratory or gastrointestinal tract infection, it has been postulated that it may represent a hypersensitivity reaction or may be related to local or systemic dysregulation of cytokine secretion.^3,4 In addition to respiratory or gastrointestinal tract infections, SS has been reported in association with malignancies, autoimmune diseases, drugs, vaccines, pregnancy, inflammatory bowel disease, and chemotherapy. It also may be idiopathic.⁵

The eruption of SS manifests as erythematous, indurated, and sharply demarcated plaques or nodules that typically favor the head, neck, and arms, with a particularly strong predilection for the dorsal aspects of the hands.⁶ Plaques and nodules are histologically characterized by a diffuse dermal neutrophilic infiltrate, papillary dermal edema, neutrophilic spongiosis, subcorneal pustules, and leukocytoclasia. Vasculitic features are not seen.⁷ The eruption typically resolves spontaneously in 5 to 12 weeks but recurs in approximately 30% of cases.⁸ Relatively common extracutaneous findings include ocular involvement, arthralgia, myalgia, and arthritis.^4,9 Both cutaneous and extracutaneous findings typically are responsive to prednisone at a dosage of 0.5 to 1 mg/kg daily for 4 to 6 weeks. Prolonged low-dose prednisone for 2 to 3 additional months may be necessary to suppress recurrence.⁸ Potassium iodide at 900 mg daily may be used as an alternative regimen.^3,8

Sweet syndrome is divided into 5 subcategories based on the underlying etiology: (1) classic or idiopathic, (2) paraneoplastic, (3) inflammatory and/or autoimmune disease related, (4) pregnancy related, and (5) drug induced.³ Although drug-induced SS comprises the minority of total cases (<5%), its reported incidence has been rising in recent years and has been associated with an escalating number of medications.¹⁰ We report a rare case of SS induced by administration of oral acetaminophen-codeine.

Case Report

A 32-year-old man with a history of diabetes mellitus underwent postoperative repair of a facial fracture. The patient was administered an oral acetaminophen-codeine suspension for postoperative pain control. One week later, he developed a painful eruption on the forehead and presented to the emergency department. He was prescribed acetaminophen-codeine 300/30-mg tablets every 6 hours in addition to hydrocortisone cream 1% applied every 6 hours. After this reintroduction of oral acetaminophen-codeine, he experienced intermittent fevers and an exacerbation of the initial cutaneous eruption. The patient presented for a second time 2 days after being seen in the emergency department and a dermatology consultation was obtained.

At the time of consultation, the patient was noted to have injected conjunctiva and erythematous, well-demarcated, and indurated plaques on the forehead with associated pain and burning (Figures 1A and 1B). Additional erythematous annular plaques were found on the palms, arms, and right knee. Laboratory workup revealed only mild anemia on complete blood cell count with a white blood cell count of 10.1×10⁹/L (reference range, 4.5–11.0×10⁹/L), hemoglobin of 12.9 g/dL (reference range, 14.0–17.4 g/dL), and hematocrit of 37.3% (reference range, 41%–50%). The platelet count was 284×10³/µL (reference range, 150–350×10³/µL). Basic metabolic panel was notable for an elevated glucose level of 418 mg/dL (reference range, 70–110 mg/dL). The most recent hemoglobin A_1C (several months prior) was notable at 14.7% of total hemoglobin (reference range, 4%–7% of total hemoglobin). A 4-mm punch biopsy of the right side of the forehead demonstrated minimal to mild papillary dermal edema and a diffuse dermal neutrophilic infiltrate spanning the upper, middle, and lower dermis with evidence of mild leukocytoclasia and no evidence of leukocytoclastic vasculitis (Figure 2). These histologic features together with the clinical presentation were consistent with a diagnosis of SS.

After an initial dose of intravenous methylprednisolone sodium succinate 125 mg in the emergency department, the patient was admitted for additional intravenous steroid administration in the context of uncontrolled hyperglycemia and history of poor glucose control. Upon admission, acetaminophen-codeine was discontinued and the patient was transitioned to intravenous methylprednisolone sodium succinate 60 mg every 8 hours. The patient also was given intravenous diphenhydramine 25 mg every 6 hours and desonide ointment 0.05% was applied to facial lesions. The inpatient medication regimen resulted in notable improvement of symptoms within 48 hours. Due to rapid improvement with steroids, no special stains for infectious etiologies were performed. The patient was discharged after 3 days in the hospital with triamcinolone ointment 0.1% to be applied to affected areas twice daily. The patient experienced no recurrence 2 months after treatment (Figure 1C).

Comment

Although SS itself is relatively rare, there has been an increasing incidence of the drug-induced subtype, most often in association with use of granulocyte colony-stimulating factor and granulocyte monocyte-stimulating factor. There also have been reported associations with a growing number of medications that include antibiotics, antiepileptic drugs, furosemide, hydralazine, and all-trans retinoic acid.^11-19 Moghimi et al¹¹ also reported an association with antivirals, cancer biotherapies, nonsteroidal anti-inflammatory drugs, psychotropes, azathioprine, oral contraceptives, and propylthiouracil.^10,20-26 Moghimi et al¹¹ further reported an association with several vaccines.

Several therapies for advanced melanoma also have been reviewed in the literature, including ipilimumab and vemurafenib,^27-30 as have several medications for the treatment of myelodysplastic syndrome including azacitidine.^31,32 A severe episode of drug-induced SS, predominantly on the legs, has been reported in association with lenalidomide, an immunomodulatory agent used in the treatment of myelodysplastic syndrome.³³

Additional medications more recently involved in the pathogenesis of drug-induced SS include the chemotherapeutic agents topetecan, mitoxantrone, gemcitabine, and vorinostat.^34-37 The antimalarial medication chloroquine also has been implicated, as have selective cyclooxygenase-2 inhibitors, hypomethylating agents, the tumor necrosis factor inhibitor adalimumab, IL-2 therapies, aripiprazole, and several other medications.^38-49

Despite drug-induced SS being reported in association with an increasing number of medications, there had been a lack of appropriate diagnostic criteria. To that end, Walker and Cohen⁵⁰ proposed 5 specific diagnostic criteria in 1996, including abrupt onset of painful erythematous plaques or nodules, histopathologic evidence of a dense neutrophilic infiltrate without evidence of leukocytoclastic vasculitis, pyrexia (temperature >38°C), temporal relationship between drug ingestion and clinical presentation or temporally related recurrence after oral rechallenge, and temporally related resolution of lesions after drug withdrawal or treatment with systemic corticosteroids.^50,51 Our patient met all of these criteria.

Conclusion

The number of cases of drug-induced SS in the literature continues to climb; however, the association with acetaminophen-codeine is unique. The importance of this case lies in educating both physicians and pharmacists alike regarding a newly recognized adverse effect of acetaminophen-codeine. Because acetaminophen-codeine often is used for its analgesic properties, and the predominant symptom of the cutaneous eruption of SS is pain, the therapeutic value of acetaminophen-codeine is substantially diminished in acetaminophen-codeine–induced SS. Accordingly, in these cases, the medication may be discontinued or substituted upon recognition of this adverse reaction to reduce patient morbidity.

In 1964, Sweet¹ described 8 women with acute onset of fever and erythematous plaques associated with a nonspecific infection of the respiratory or gastrointestinal tract. The lesions were histologically characterized by a neutrophilic infiltrate, and the author named the constellation of findings acute febrile neutrophilic dermatosis.¹ In 1968, Whittle et al² reported on similar cases and coined the term Sweet syndrome (SS).

Although the etiology and pathogenesis of SS remain unknown, several theories have been proposed. Because SS often is preceded by a respiratory or gastrointestinal tract infection, it has been postulated that it may represent a hypersensitivity reaction or may be related to local or systemic dysregulation of cytokine secretion.^3,4 In addition to respiratory or gastrointestinal tract infections, SS has been reported in association with malignancies, autoimmune diseases, drugs, vaccines, pregnancy, inflammatory bowel disease, and chemotherapy. It also may be idiopathic.⁵

The eruption of SS manifests as erythematous, indurated, and sharply demarcated plaques or nodules that typically favor the head, neck, and arms, with a particularly strong predilection for the dorsal aspects of the hands.⁶ Plaques and nodules are histologically characterized by a diffuse dermal neutrophilic infiltrate, papillary dermal edema, neutrophilic spongiosis, subcorneal pustules, and leukocytoclasia. Vasculitic features are not seen.⁷ The eruption typically resolves spontaneously in 5 to 12 weeks but recurs in approximately 30% of cases.⁸ Relatively common extracutaneous findings include ocular involvement, arthralgia, myalgia, and arthritis.^4,9 Both cutaneous and extracutaneous findings typically are responsive to prednisone at a dosage of 0.5 to 1 mg/kg daily for 4 to 6 weeks. Prolonged low-dose prednisone for 2 to 3 additional months may be necessary to suppress recurrence.⁸ Potassium iodide at 900 mg daily may be used as an alternative regimen.^3,8

Sweet syndrome is divided into 5 subcategories based on the underlying etiology: (1) classic or idiopathic, (2) paraneoplastic, (3) inflammatory and/or autoimmune disease related, (4) pregnancy related, and (5) drug induced.³ Although drug-induced SS comprises the minority of total cases (<5%), its reported incidence has been rising in recent years and has been associated with an escalating number of medications.¹⁰ We report a rare case of SS induced by administration of oral acetaminophen-codeine.

Case Report

A 32-year-old man with a history of diabetes mellitus underwent postoperative repair of a facial fracture. The patient was administered an oral acetaminophen-codeine suspension for postoperative pain control. One week later, he developed a painful eruption on the forehead and presented to the emergency department. He was prescribed acetaminophen-codeine 300/30-mg tablets every 6 hours in addition to hydrocortisone cream 1% applied every 6 hours. After this reintroduction of oral acetaminophen-codeine, he experienced intermittent fevers and an exacerbation of the initial cutaneous eruption. The patient presented for a second time 2 days after being seen in the emergency department and a dermatology consultation was obtained.

At the time of consultation, the patient was noted to have injected conjunctiva and erythematous, well-demarcated, and indurated plaques on the forehead with associated pain and burning (Figures 1A and 1B). Additional erythematous annular plaques were found on the palms, arms, and right knee. Laboratory workup revealed only mild anemia on complete blood cell count with a white blood cell count of 10.1×10⁹/L (reference range, 4.5–11.0×10⁹/L), hemoglobin of 12.9 g/dL (reference range, 14.0–17.4 g/dL), and hematocrit of 37.3% (reference range, 41%–50%). The platelet count was 284×10³/µL (reference range, 150–350×10³/µL). Basic metabolic panel was notable for an elevated glucose level of 418 mg/dL (reference range, 70–110 mg/dL). The most recent hemoglobin A_1C (several months prior) was notable at 14.7% of total hemoglobin (reference range, 4%–7% of total hemoglobin). A 4-mm punch biopsy of the right side of the forehead demonstrated minimal to mild papillary dermal edema and a diffuse dermal neutrophilic infiltrate spanning the upper, middle, and lower dermis with evidence of mild leukocytoclasia and no evidence of leukocytoclastic vasculitis (Figure 2). These histologic features together with the clinical presentation were consistent with a diagnosis of SS.

After an initial dose of intravenous methylprednisolone sodium succinate 125 mg in the emergency department, the patient was admitted for additional intravenous steroid administration in the context of uncontrolled hyperglycemia and history of poor glucose control. Upon admission, acetaminophen-codeine was discontinued and the patient was transitioned to intravenous methylprednisolone sodium succinate 60 mg every 8 hours. The patient also was given intravenous diphenhydramine 25 mg every 6 hours and desonide ointment 0.05% was applied to facial lesions. The inpatient medication regimen resulted in notable improvement of symptoms within 48 hours. Due to rapid improvement with steroids, no special stains for infectious etiologies were performed. The patient was discharged after 3 days in the hospital with triamcinolone ointment 0.1% to be applied to affected areas twice daily. The patient experienced no recurrence 2 months after treatment (Figure 1C).

Comment

Although SS itself is relatively rare, there has been an increasing incidence of the drug-induced subtype, most often in association with use of granulocyte colony-stimulating factor and granulocyte monocyte-stimulating factor. There also have been reported associations with a growing number of medications that include antibiotics, antiepileptic drugs, furosemide, hydralazine, and all-trans retinoic acid.^11-19 Moghimi et al¹¹ also reported an association with antivirals, cancer biotherapies, nonsteroidal anti-inflammatory drugs, psychotropes, azathioprine, oral contraceptives, and propylthiouracil.^10,20-26 Moghimi et al¹¹ further reported an association with several vaccines.

Several therapies for advanced melanoma also have been reviewed in the literature, including ipilimumab and vemurafenib,^27-30 as have several medications for the treatment of myelodysplastic syndrome including azacitidine.^31,32 A severe episode of drug-induced SS, predominantly on the legs, has been reported in association with lenalidomide, an immunomodulatory agent used in the treatment of myelodysplastic syndrome.³³

Additional medications more recently involved in the pathogenesis of drug-induced SS include the chemotherapeutic agents topetecan, mitoxantrone, gemcitabine, and vorinostat.^34-37 The antimalarial medication chloroquine also has been implicated, as have selective cyclooxygenase-2 inhibitors, hypomethylating agents, the tumor necrosis factor inhibitor adalimumab, IL-2 therapies, aripiprazole, and several other medications.^38-49

Despite drug-induced SS being reported in association with an increasing number of medications, there had been a lack of appropriate diagnostic criteria. To that end, Walker and Cohen⁵⁰ proposed 5 specific diagnostic criteria in 1996, including abrupt onset of painful erythematous plaques or nodules, histopathologic evidence of a dense neutrophilic infiltrate without evidence of leukocytoclastic vasculitis, pyrexia (temperature >38°C), temporal relationship between drug ingestion and clinical presentation or temporally related recurrence after oral rechallenge, and temporally related resolution of lesions after drug withdrawal or treatment with systemic corticosteroids.^50,51 Our patient met all of these criteria.

Conclusion

The number of cases of drug-induced SS in the literature continues to climb; however, the association with acetaminophen-codeine is unique. The importance of this case lies in educating both physicians and pharmacists alike regarding a newly recognized adverse effect of acetaminophen-codeine. Because acetaminophen-codeine often is used for its analgesic properties, and the predominant symptom of the cutaneous eruption of SS is pain, the therapeutic value of acetaminophen-codeine is substantially diminished in acetaminophen-codeine–induced SS. Accordingly, in these cases, the medication may be discontinued or substituted upon recognition of this adverse reaction to reduce patient morbidity.

CHICAGO – Treating even uncomplicated acute otitis media (AOM) in 2017 may not be as simple as writing an amoxicillin prescription. Changes in pathogens may mean a shift in prescribing practices, Ellen Wald, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Wald, speaking to an audience that filled the lecture hall and an overflow room, said that there has long been good reason to turn to amoxicillin for AOM. “The reason that pediatricians and others like to reserve the use of amoxicillin as first-line therapy for children with AOM is that it is generally effective, it’s safe, it’s narrow in spectrum, and it’s relatively inexpensive. Those are all very desirable characteristics.”

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Dr. Wald reported that she had no conflicts of interest.

[email protected]

On Twitter @karioakes

CHICAGO – Treating even uncomplicated acute otitis media (AOM) in 2017 may not be as simple as writing an amoxicillin prescription. Changes in pathogens may mean a shift in prescribing practices, Ellen Wald, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Wald, speaking to an audience that filled the lecture hall and an overflow room, said that there has long been good reason to turn to amoxicillin for AOM. “The reason that pediatricians and others like to reserve the use of amoxicillin as first-line therapy for children with AOM is that it is generally effective, it’s safe, it’s narrow in spectrum, and it’s relatively inexpensive. Those are all very desirable characteristics.”

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Dr. Wald reported that she had no conflicts of interest.

[email protected]

On Twitter @karioakes

CHICAGO – Treating even uncomplicated acute otitis media (AOM) in 2017 may not be as simple as writing an amoxicillin prescription. Changes in pathogens may mean a shift in prescribing practices, Ellen Wald, MD, said at the annual meeting of the American Academy of Pediatrics.

Dr. Wald, speaking to an audience that filled the lecture hall and an overflow room, said that there has long been good reason to turn to amoxicillin for AOM. “The reason that pediatricians and others like to reserve the use of amoxicillin as first-line therapy for children with AOM is that it is generally effective, it’s safe, it’s narrow in spectrum, and it’s relatively inexpensive. Those are all very desirable characteristics.”

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Dr. Wald reported that she had no conflicts of interest.

[email protected]

On Twitter @karioakes

I’ve previously written about “the monster note,” a creation of autofilled blanks with vital signs and test results that tells you very little about what’s really going on.

Recently, while on call, I discovered a new problem: the lack of a decent impression.

I was covering for another doctor, and a cardiologist rounding at a rehab center called to see if he could anticoagulate a recently discharged patient. It was certainly a reasonable question.

copyright BrianAJackson/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I’ve previously written about “the monster note,” a creation of autofilled blanks with vital signs and test results that tells you very little about what’s really going on.

Recently, while on call, I discovered a new problem: the lack of a decent impression.

I was covering for another doctor, and a cardiologist rounding at a rehab center called to see if he could anticoagulate a recently discharged patient. It was certainly a reasonable question.

copyright BrianAJackson/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I’ve previously written about “the monster note,” a creation of autofilled blanks with vital signs and test results that tells you very little about what’s really going on.

Recently, while on call, I discovered a new problem: the lack of a decent impression.

I was covering for another doctor, and a cardiologist rounding at a rehab center called to see if he could anticoagulate a recently discharged patient. It was certainly a reasonable question.

copyright BrianAJackson/Thinkstock

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

First introduced in 2008 as a surgical treatment of chronic conjunctival injection, cosmetic eye whitening became popularized in South Korea¹ and has been performed in more than 1800 patients in the United States.^1-3 Individuals with healthy eyes who elect to undergo this procedure often present with concerns of hyperemia, undesirable ocular pigmentation, or pingueculas. An initial report from Kim⁴ described 571 patients who underwent regional conjunctivectomy for persistent irreversible hyperemic conjunctiva with a 94.6% postoperative satisfaction rate. In contrast, over the last 5 years, various reported permanent complications raised concerns of the risk-benefit ratio of this cosmetic procedure.

The procedure involves performing a localized conjunctivectomy with or without removal of the Tenon capsule.⁴ Brimonidine tartrate is given for vascular constriction. When conjunctivectomy is performed in the right eye, the medial conjunctiva is incised from the 2-o’clock to 5-o’clock positions and the lateral conjunctiva is incised from the 10-o’clock to 7-o’clock positions. After the conjunctiva and Tenon capsule are excised, hemostasis is achieved with electrocauterization. Postoperative management may consist of topical mitomycin C (MMC) 0.02% 4 times daily for 2 to 5 days along with topical steroids. The addition of bevacizumab 1.25 mg/mL also has been described.⁵

In this report, we provide a comprehensive review of the complications of cosmetic eye whitening based on a review of the literature. Clinicians in both aesthetic practice and ophthalmology should be aware of the potential complications to accurately educate their patients about the possible risks and benefits of this procedure.

Methods

A review of PubMed articles indexed for MEDLINE (January 2009 to July 2017) using the search terms cosmetic eye whitening, cosmetic wide conjunctivectomy, I-Brite, and chronic hyperemic conjuctiva was conducted to evaluate the number of reports of complications from cosmetic eye whitening. A total of 10 articles were included in the study based on a review of abstracts. Non–English-language abstracts were not reviewed.

Results

Based on a review of 10 articles commenting on the complications of cosmetic eye whitening, a total of 2400 patients had undergone a cosmetic conjunctivectomy with various postoperative complications and recurrences (Table).^4-13 The most commonly recurring complications based on the reported frequencies in the articles included chronic conjunctival epithelial defects, scleral thinning, calcific plaques, dry eye syndrome, diplopia (sometimes requiring strabismus surgery), and elevated intraocular pressure.

Kim⁴ was the first to report this surgical technique for irreversible hyperemic conjunctiva (N=1815). The reported success rate in South Korea was overwhelmingly high at 94.6%. In a mean (SD) follow-up time of 12.9 (7.8) months (range, 2–27 months), less than 20% of patients required surgical revision. During this time, the most common postoperative complications included elevation in intraocular pressure (17.2%), conjunctival granuloma (8.4%), transient vision decrease (7.5%), pigment deposition (5.3%), scleral calcifications (3.9%), and diplopia secondary to conjunctival adhesions (1.6%). No permanent defects were reported, and complications improved with surgical and medical management.⁴

Contrary to the findings of Kim,⁴ a large number of complications were seen; thus, on March 4, 2011, the Korean Ministry of Health & Welfare issued a declaration to discontinue the procedure under Article 49 of the Medical Service Act. Medical records from the single clinic in Korea from November 2007 to May 2010 were reviewed.⁵ One of the largest reviews of cosmetic eye whitening complications reviewed 1713 patients who underwent conjunctivectomy plus topical MMC with or without bevacizumab injection. Pterygium and chronic conjunctival hyperemia were the most common diagnoses that prompted patients to undergo treatment. Over an average follow-up period of 10.9 months, the overall complication rate was 82.9%, with severe complications being fibrovascular conjunctival proliferation (43.8%), recurrent hyperemic conjunctiva (28.1%), intraocular pressure (13.1%), scleral thinning with calcified plaques (6.2%), scleral thinning (4.4%), and diplopia (3.6%). A total of 56.9% of patients reported being satisfied with the cosmetic outcome of the surgery.⁵

In some of the smaller case series and case reports we reviewed, more vision-threatening complications have been described. Infectious endophthalmitis, infectious scleritis, and necrotizing scleritis have all been reported as complications of cosmetic eye whitening.^8,10

Comment

The pathophysiology of the complications of cosmetic eye whitening stem from the disruption of the normal conjunctiva, destruction of the vascularization to the sclera, and loss of limbal stem cells. Mitomycin C is a topical antimetabolite antibiotic agent that inhibits DNA synthesis. This relatively safe and inexpensive product has decreased the recurrence rate in pterygium surgery as early as 1963.^14,15 Complications of MMC in pterygium surgery include infectious scleritis, necrotizing scleritis, calcium formation, and even scleromalacia, occurring at incidence rates as low as 1.4%.¹⁶ These risks are balanced against the medical necessity of using MMC. Given the elective nature of cosmetic eye whitening, these complications in a cosmetic setting may not be justified.

The debate of the use of this procedure continues to occur in ophthalmologic societies. Both the Korean Ministry of Health & Welfare and the American Society of Cataract Refractive Surgery do not condone the use of regional conjunctivectomy for cosmetic eye whitening.^5,17 Evidence shows that complications from cosmetic conjunctivectomy can be devastating and unnecessary given its elective nature. Although some complications (eg, dry eye syndrome, pain, discomfort) may be considered mild, the number of potentially serious complications brings the usefulness of the procedure into question.

This review is a launchpad to inform the medical community of the potential downside to conjunctivectomy for cosmetic eye whitening with the hope that it can initiate meaningful risk-benefit discussions between providers and physicians.

First introduced in 2008 as a surgical treatment of chronic conjunctival injection, cosmetic eye whitening became popularized in South Korea¹ and has been performed in more than 1800 patients in the United States.^1-3 Individuals with healthy eyes who elect to undergo this procedure often present with concerns of hyperemia, undesirable ocular pigmentation, or pingueculas. An initial report from Kim⁴ described 571 patients who underwent regional conjunctivectomy for persistent irreversible hyperemic conjunctiva with a 94.6% postoperative satisfaction rate. In contrast, over the last 5 years, various reported permanent complications raised concerns of the risk-benefit ratio of this cosmetic procedure.

The procedure involves performing a localized conjunctivectomy with or without removal of the Tenon capsule.⁴ Brimonidine tartrate is given for vascular constriction. When conjunctivectomy is performed in the right eye, the medial conjunctiva is incised from the 2-o’clock to 5-o’clock positions and the lateral conjunctiva is incised from the 10-o’clock to 7-o’clock positions. After the conjunctiva and Tenon capsule are excised, hemostasis is achieved with electrocauterization. Postoperative management may consist of topical mitomycin C (MMC) 0.02% 4 times daily for 2 to 5 days along with topical steroids. The addition of bevacizumab 1.25 mg/mL also has been described.⁵

In this report, we provide a comprehensive review of the complications of cosmetic eye whitening based on a review of the literature. Clinicians in both aesthetic practice and ophthalmology should be aware of the potential complications to accurately educate their patients about the possible risks and benefits of this procedure.

Methods

A review of PubMed articles indexed for MEDLINE (January 2009 to July 2017) using the search terms cosmetic eye whitening, cosmetic wide conjunctivectomy, I-Brite, and chronic hyperemic conjuctiva was conducted to evaluate the number of reports of complications from cosmetic eye whitening. A total of 10 articles were included in the study based on a review of abstracts. Non–English-language abstracts were not reviewed.

Results

Based on a review of 10 articles commenting on the complications of cosmetic eye whitening, a total of 2400 patients had undergone a cosmetic conjunctivectomy with various postoperative complications and recurrences (Table).^4-13 The most commonly recurring complications based on the reported frequencies in the articles included chronic conjunctival epithelial defects, scleral thinning, calcific plaques, dry eye syndrome, diplopia (sometimes requiring strabismus surgery), and elevated intraocular pressure.

Kim⁴ was the first to report this surgical technique for irreversible hyperemic conjunctiva (N=1815). The reported success rate in South Korea was overwhelmingly high at 94.6%. In a mean (SD) follow-up time of 12.9 (7.8) months (range, 2–27 months), less than 20% of patients required surgical revision. During this time, the most common postoperative complications included elevation in intraocular pressure (17.2%), conjunctival granuloma (8.4%), transient vision decrease (7.5%), pigment deposition (5.3%), scleral calcifications (3.9%), and diplopia secondary to conjunctival adhesions (1.6%). No permanent defects were reported, and complications improved with surgical and medical management.⁴

Contrary to the findings of Kim,⁴ a large number of complications were seen; thus, on March 4, 2011, the Korean Ministry of Health & Welfare issued a declaration to discontinue the procedure under Article 49 of the Medical Service Act. Medical records from the single clinic in Korea from November 2007 to May 2010 were reviewed.⁵ One of the largest reviews of cosmetic eye whitening complications reviewed 1713 patients who underwent conjunctivectomy plus topical MMC with or without bevacizumab injection. Pterygium and chronic conjunctival hyperemia were the most common diagnoses that prompted patients to undergo treatment. Over an average follow-up period of 10.9 months, the overall complication rate was 82.9%, with severe complications being fibrovascular conjunctival proliferation (43.8%), recurrent hyperemic conjunctiva (28.1%), intraocular pressure (13.1%), scleral thinning with calcified plaques (6.2%), scleral thinning (4.4%), and diplopia (3.6%). A total of 56.9% of patients reported being satisfied with the cosmetic outcome of the surgery.⁵

In some of the smaller case series and case reports we reviewed, more vision-threatening complications have been described. Infectious endophthalmitis, infectious scleritis, and necrotizing scleritis have all been reported as complications of cosmetic eye whitening.^8,10

Comment

The pathophysiology of the complications of cosmetic eye whitening stem from the disruption of the normal conjunctiva, destruction of the vascularization to the sclera, and loss of limbal stem cells. Mitomycin C is a topical antimetabolite antibiotic agent that inhibits DNA synthesis. This relatively safe and inexpensive product has decreased the recurrence rate in pterygium surgery as early as 1963.^14,15 Complications of MMC in pterygium surgery include infectious scleritis, necrotizing scleritis, calcium formation, and even scleromalacia, occurring at incidence rates as low as 1.4%.¹⁶ These risks are balanced against the medical necessity of using MMC. Given the elective nature of cosmetic eye whitening, these complications in a cosmetic setting may not be justified.

The debate of the use of this procedure continues to occur in ophthalmologic societies. Both the Korean Ministry of Health & Welfare and the American Society of Cataract Refractive Surgery do not condone the use of regional conjunctivectomy for cosmetic eye whitening.^5,17 Evidence shows that complications from cosmetic conjunctivectomy can be devastating and unnecessary given its elective nature. Although some complications (eg, dry eye syndrome, pain, discomfort) may be considered mild, the number of potentially serious complications brings the usefulness of the procedure into question.

This review is a launchpad to inform the medical community of the potential downside to conjunctivectomy for cosmetic eye whitening with the hope that it can initiate meaningful risk-benefit discussions between providers and physicians.

First introduced in 2008 as a surgical treatment of chronic conjunctival injection, cosmetic eye whitening became popularized in South Korea¹ and has been performed in more than 1800 patients in the United States.^1-3 Individuals with healthy eyes who elect to undergo this procedure often present with concerns of hyperemia, undesirable ocular pigmentation, or pingueculas. An initial report from Kim⁴ described 571 patients who underwent regional conjunctivectomy for persistent irreversible hyperemic conjunctiva with a 94.6% postoperative satisfaction rate. In contrast, over the last 5 years, various reported permanent complications raised concerns of the risk-benefit ratio of this cosmetic procedure.

The procedure involves performing a localized conjunctivectomy with or without removal of the Tenon capsule.⁴ Brimonidine tartrate is given for vascular constriction. When conjunctivectomy is performed in the right eye, the medial conjunctiva is incised from the 2-o’clock to 5-o’clock positions and the lateral conjunctiva is incised from the 10-o’clock to 7-o’clock positions. After the conjunctiva and Tenon capsule are excised, hemostasis is achieved with electrocauterization. Postoperative management may consist of topical mitomycin C (MMC) 0.02% 4 times daily for 2 to 5 days along with topical steroids. The addition of bevacizumab 1.25 mg/mL also has been described.⁵

In this report, we provide a comprehensive review of the complications of cosmetic eye whitening based on a review of the literature. Clinicians in both aesthetic practice and ophthalmology should be aware of the potential complications to accurately educate their patients about the possible risks and benefits of this procedure.

Methods

A review of PubMed articles indexed for MEDLINE (January 2009 to July 2017) using the search terms cosmetic eye whitening, cosmetic wide conjunctivectomy, I-Brite, and chronic hyperemic conjuctiva was conducted to evaluate the number of reports of complications from cosmetic eye whitening. A total of 10 articles were included in the study based on a review of abstracts. Non–English-language abstracts were not reviewed.

Results

Based on a review of 10 articles commenting on the complications of cosmetic eye whitening, a total of 2400 patients had undergone a cosmetic conjunctivectomy with various postoperative complications and recurrences (Table).^4-13 The most commonly recurring complications based on the reported frequencies in the articles included chronic conjunctival epithelial defects, scleral thinning, calcific plaques, dry eye syndrome, diplopia (sometimes requiring strabismus surgery), and elevated intraocular pressure.

Kim⁴ was the first to report this surgical technique for irreversible hyperemic conjunctiva (N=1815). The reported success rate in South Korea was overwhelmingly high at 94.6%. In a mean (SD) follow-up time of 12.9 (7.8) months (range, 2–27 months), less than 20% of patients required surgical revision. During this time, the most common postoperative complications included elevation in intraocular pressure (17.2%), conjunctival granuloma (8.4%), transient vision decrease (7.5%), pigment deposition (5.3%), scleral calcifications (3.9%), and diplopia secondary to conjunctival adhesions (1.6%). No permanent defects were reported, and complications improved with surgical and medical management.⁴

Contrary to the findings of Kim,⁴ a large number of complications were seen; thus, on March 4, 2011, the Korean Ministry of Health & Welfare issued a declaration to discontinue the procedure under Article 49 of the Medical Service Act. Medical records from the single clinic in Korea from November 2007 to May 2010 were reviewed.⁵ One of the largest reviews of cosmetic eye whitening complications reviewed 1713 patients who underwent conjunctivectomy plus topical MMC with or without bevacizumab injection. Pterygium and chronic conjunctival hyperemia were the most common diagnoses that prompted patients to undergo treatment. Over an average follow-up period of 10.9 months, the overall complication rate was 82.9%, with severe complications being fibrovascular conjunctival proliferation (43.8%), recurrent hyperemic conjunctiva (28.1%), intraocular pressure (13.1%), scleral thinning with calcified plaques (6.2%), scleral thinning (4.4%), and diplopia (3.6%). A total of 56.9% of patients reported being satisfied with the cosmetic outcome of the surgery.⁵

In some of the smaller case series and case reports we reviewed, more vision-threatening complications have been described. Infectious endophthalmitis, infectious scleritis, and necrotizing scleritis have all been reported as complications of cosmetic eye whitening.^8,10

Comment

The pathophysiology of the complications of cosmetic eye whitening stem from the disruption of the normal conjunctiva, destruction of the vascularization to the sclera, and loss of limbal stem cells. Mitomycin C is a topical antimetabolite antibiotic agent that inhibits DNA synthesis. This relatively safe and inexpensive product has decreased the recurrence rate in pterygium surgery as early as 1963.^14,15 Complications of MMC in pterygium surgery include infectious scleritis, necrotizing scleritis, calcium formation, and even scleromalacia, occurring at incidence rates as low as 1.4%.¹⁶ These risks are balanced against the medical necessity of using MMC. Given the elective nature of cosmetic eye whitening, these complications in a cosmetic setting may not be justified.

The debate of the use of this procedure continues to occur in ophthalmologic societies. Both the Korean Ministry of Health & Welfare and the American Society of Cataract Refractive Surgery do not condone the use of regional conjunctivectomy for cosmetic eye whitening.^5,17 Evidence shows that complications from cosmetic conjunctivectomy can be devastating and unnecessary given its elective nature. Although some complications (eg, dry eye syndrome, pain, discomfort) may be considered mild, the number of potentially serious complications brings the usefulness of the procedure into question.

This review is a launchpad to inform the medical community of the potential downside to conjunctivectomy for cosmetic eye whitening with the hope that it can initiate meaningful risk-benefit discussions between providers and physicians.

Apolipoprotein E protein isoforms, particularly ApoE4, appear to accelerate brain-wide tau propagation that eventually leads to neuronal injury and death in a manner independent from amyloid-beta, according to findings from transgenic mouse model studies.

“We found ApoE itself, especially ApoE4, was essential to neuronal death,” wrote first author Yang Shi of Washington University, St. Louis, and her colleagues, led by David M. Holtzman, MD, in new research published in Nature. “With pathological tau accumulation, the presence of ApoE, especially ApoE4, may make neurons more susceptible to degeneration, whereas the absence of ApoE may protect neurons from death.”

The new research also illustrates a differential effect between the three APOE alleles. In the team’s in vivo study, tau-expressing mice with the APOE4 allele were most affected, and those with the E3 and E2 versions progressively less so. Mice that didn’t express the human gene at all showed no change in tau and no immune reaction (Nature. 2017;549:523-7).

This new picture of tauopathy – a common feature in Alzheimer’s, frontotemporal dementia, corticobasal degeneration, Pick disease, and progressive supranuclear palsy – suggests an expanded role for ApoE, which until now has been associated mostly with increased amyloid deposition in the Alzheimer’s disease (AD) brain.

Evidence of ApoE4’s greater impact

To examine ApoE’s effect on tau, the research team bred new lines of genetically modified mice, all of which expressed human tau. Some also expressed human ApoE4, E3, or E2 in place of mouse ApoE. A comparator mouse expressed tau, but not ApoE.

By the time the mice were 9 months old, the tau-E4 strain showed significantly more brain atrophy than did the tau-E3 and tau-E2 strains. The mice who expressed tau but were free of ApoE showed no brain changes.

A closer look showed that atrophy occurred primarily in areas associated with the cognitive changes seen in dementia: the hippocampus, piriform/entorhinal cortex, and amygdala. The ventricles were also enlarged.

“These results revealed an important role of ApoE in regulating tau-mediated neurodegeneration, with ApoE4 causing more severe damage and the absence of ApoE being protective,” the investigators wrote.

The E4/tau tango started early, too, the team noted. At 3 months old, tau-E4 mice had no obvious brain atrophy, but already had significantly more soluble tau than did any of the other strains. By 9 months, when tauopathy was obvious, the tau-E4 mice still had more of the protein, which had shifted from a soluble to an insoluble and hyperphosphorylated state. The tau-E4 mice didn’t appear to be making more tau than the others, though; rather, they were less able to clear it through the neurons’ clearing and recycling system of autophagy.

Drilling down further into the neurons’ pathophysiology, the team found that tau first appeared in the axons of dentate gyrus granule cells in the hippocampus, and then, at an early age, moved into the cell body. Again, there were APOE allele–specific patterns to tau propagation. The team saw four major tau staining patterns, which correlated with the level of brain atrophy. Types 1 and 2, associated with least atrophy, occurred most often in the tau-only, ApoE-negative mice; type 4, associated with the greatest atrophy, occurred most often in the tau-E4 mice.

“The featured distribution of these ... patterns, which either represent different tau structures or progressively more advanced pathological tau stages, indicate ApoE affects either tau conformation or tau pathology progression,” the investigators wrote.
 

Greatest neurodegeneration seen with ApoE4

Tau-mediated neurodegeneration initiated levels of inflammatory response that also depended on the type of ApoE isoform. Exposure to a culture of damaged neurons and mixed glial cells caused microglia to release a flood of inflammatory cytokines that called in a host of astrocytes to kill damaged tau-E4 neurons en masse, but attacked the tau-E3, tau-E2, and tau-only strains much less. This finding indicates that “ApoE itself was directly involved in inducing neurotoxicity in tau-expressing susceptible neurons,” the team wrote.

Finally, they investigated this model of neurodegeneration in postmortem brain samples of patients with corticobasal degeneration, Pick disease, and progressive supranuclear palsy – the three most common sporadic primary tauopathies. Patients with the E4 allele showed more severe neurodegeneration and a greater interaction of tau pathology and neurodegeneration. Amyloid deposition was associated with less severe neurodegeneration.

Taken together, the findings strongly suggest that the high-risk APOE4 allele is the linchpin that links neuroinflammation to neuronal death in the setting of tau pathology, the investigators concluded.

“The presence of degenerating neurons appeared to further induce neuroinflammation, which was augmented by ApoE4 owing to its inherently higher innate immune reactivity. While activated microglia may be protective to some extent in the setting of amyloid-beta pathology, by targeting plaques and reducing dystrophic neurites, they could be deleterious in tauopathy by directly targeting injured neurons and by activating toxic astrocytes. Enhanced neuroinflammation associated with ApoE4 may further exacerbate neurodegeneration.”

The study was funded by grants awarded to multiple investigators by the National Institutes of Health, the JPB Foundation, Cure Alzheimer’s Fund, AstraZeneca, the Consortium for Frontotemporal Dementia Research, the Tau Consortium, the National Multiple Sclerosis Society, the Nancy Davis Foundation, and the Amyotrophic Lateral Sclerosis Association. Dr. Holtzman cofounded and is on the scientific advisory board of C2N Diagnostics. He consults for Genentech, AbbVie, Eli Lilly, Proclara, GlaxoSmithKline, and Denali. Dr. Holtzman’s lab is funded by institutional research grants from C2N Diagnostics, Eli Lilly, AbbVie, and Denali.

[email protected]

On Twitter @Alz_Gal

Apolipoprotein E protein isoforms, particularly ApoE4, appear to accelerate brain-wide tau propagation that eventually leads to neuronal injury and death in a manner independent from amyloid-beta, according to findings from transgenic mouse model studies.

“We found ApoE itself, especially ApoE4, was essential to neuronal death,” wrote first author Yang Shi of Washington University, St. Louis, and her colleagues, led by David M. Holtzman, MD, in new research published in Nature. “With pathological tau accumulation, the presence of ApoE, especially ApoE4, may make neurons more susceptible to degeneration, whereas the absence of ApoE may protect neurons from death.”

The new research also illustrates a differential effect between the three APOE alleles. In the team’s in vivo study, tau-expressing mice with the APOE4 allele were most affected, and those with the E3 and E2 versions progressively less so. Mice that didn’t express the human gene at all showed no change in tau and no immune reaction (Nature. 2017;549:523-7).

This new picture of tauopathy – a common feature in Alzheimer’s, frontotemporal dementia, corticobasal degeneration, Pick disease, and progressive supranuclear palsy – suggests an expanded role for ApoE, which until now has been associated mostly with increased amyloid deposition in the Alzheimer’s disease (AD) brain.

Evidence of ApoE4’s greater impact

To examine ApoE’s effect on tau, the research team bred new lines of genetically modified mice, all of which expressed human tau. Some also expressed human ApoE4, E3, or E2 in place of mouse ApoE. A comparator mouse expressed tau, but not ApoE.

By the time the mice were 9 months old, the tau-E4 strain showed significantly more brain atrophy than did the tau-E3 and tau-E2 strains. The mice who expressed tau but were free of ApoE showed no brain changes.

A closer look showed that atrophy occurred primarily in areas associated with the cognitive changes seen in dementia: the hippocampus, piriform/entorhinal cortex, and amygdala. The ventricles were also enlarged.

“These results revealed an important role of ApoE in regulating tau-mediated neurodegeneration, with ApoE4 causing more severe damage and the absence of ApoE being protective,” the investigators wrote.

The E4/tau tango started early, too, the team noted. At 3 months old, tau-E4 mice had no obvious brain atrophy, but already had significantly more soluble tau than did any of the other strains. By 9 months, when tauopathy was obvious, the tau-E4 mice still had more of the protein, which had shifted from a soluble to an insoluble and hyperphosphorylated state. The tau-E4 mice didn’t appear to be making more tau than the others, though; rather, they were less able to clear it through the neurons’ clearing and recycling system of autophagy.

Drilling down further into the neurons’ pathophysiology, the team found that tau first appeared in the axons of dentate gyrus granule cells in the hippocampus, and then, at an early age, moved into the cell body. Again, there were APOE allele–specific patterns to tau propagation. The team saw four major tau staining patterns, which correlated with the level of brain atrophy. Types 1 and 2, associated with least atrophy, occurred most often in the tau-only, ApoE-negative mice; type 4, associated with the greatest atrophy, occurred most often in the tau-E4 mice.

“The featured distribution of these ... patterns, which either represent different tau structures or progressively more advanced pathological tau stages, indicate ApoE affects either tau conformation or tau pathology progression,” the investigators wrote.
 

Greatest neurodegeneration seen with ApoE4

Tau-mediated neurodegeneration initiated levels of inflammatory response that also depended on the type of ApoE isoform. Exposure to a culture of damaged neurons and mixed glial cells caused microglia to release a flood of inflammatory cytokines that called in a host of astrocytes to kill damaged tau-E4 neurons en masse, but attacked the tau-E3, tau-E2, and tau-only strains much less. This finding indicates that “ApoE itself was directly involved in inducing neurotoxicity in tau-expressing susceptible neurons,” the team wrote.

Finally, they investigated this model of neurodegeneration in postmortem brain samples of patients with corticobasal degeneration, Pick disease, and progressive supranuclear palsy – the three most common sporadic primary tauopathies. Patients with the E4 allele showed more severe neurodegeneration and a greater interaction of tau pathology and neurodegeneration. Amyloid deposition was associated with less severe neurodegeneration.

Taken together, the findings strongly suggest that the high-risk APOE4 allele is the linchpin that links neuroinflammation to neuronal death in the setting of tau pathology, the investigators concluded.

“The presence of degenerating neurons appeared to further induce neuroinflammation, which was augmented by ApoE4 owing to its inherently higher innate immune reactivity. While activated microglia may be protective to some extent in the setting of amyloid-beta pathology, by targeting plaques and reducing dystrophic neurites, they could be deleterious in tauopathy by directly targeting injured neurons and by activating toxic astrocytes. Enhanced neuroinflammation associated with ApoE4 may further exacerbate neurodegeneration.”

The study was funded by grants awarded to multiple investigators by the National Institutes of Health, the JPB Foundation, Cure Alzheimer’s Fund, AstraZeneca, the Consortium for Frontotemporal Dementia Research, the Tau Consortium, the National Multiple Sclerosis Society, the Nancy Davis Foundation, and the Amyotrophic Lateral Sclerosis Association. Dr. Holtzman cofounded and is on the scientific advisory board of C2N Diagnostics. He consults for Genentech, AbbVie, Eli Lilly, Proclara, GlaxoSmithKline, and Denali. Dr. Holtzman’s lab is funded by institutional research grants from C2N Diagnostics, Eli Lilly, AbbVie, and Denali.

[email protected]

On Twitter @Alz_Gal

Apolipoprotein E protein isoforms, particularly ApoE4, appear to accelerate brain-wide tau propagation that eventually leads to neuronal injury and death in a manner independent from amyloid-beta, according to findings from transgenic mouse model studies.

“We found ApoE itself, especially ApoE4, was essential to neuronal death,” wrote first author Yang Shi of Washington University, St. Louis, and her colleagues, led by David M. Holtzman, MD, in new research published in Nature. “With pathological tau accumulation, the presence of ApoE, especially ApoE4, may make neurons more susceptible to degeneration, whereas the absence of ApoE may protect neurons from death.”

The new research also illustrates a differential effect between the three APOE alleles. In the team’s in vivo study, tau-expressing mice with the APOE4 allele were most affected, and those with the E3 and E2 versions progressively less so. Mice that didn’t express the human gene at all showed no change in tau and no immune reaction (Nature. 2017;549:523-7).

This new picture of tauopathy – a common feature in Alzheimer’s, frontotemporal dementia, corticobasal degeneration, Pick disease, and progressive supranuclear palsy – suggests an expanded role for ApoE, which until now has been associated mostly with increased amyloid deposition in the Alzheimer’s disease (AD) brain.

Evidence of ApoE4’s greater impact

To examine ApoE’s effect on tau, the research team bred new lines of genetically modified mice, all of which expressed human tau. Some also expressed human ApoE4, E3, or E2 in place of mouse ApoE. A comparator mouse expressed tau, but not ApoE.

By the time the mice were 9 months old, the tau-E4 strain showed significantly more brain atrophy than did the tau-E3 and tau-E2 strains. The mice who expressed tau but were free of ApoE showed no brain changes.

A closer look showed that atrophy occurred primarily in areas associated with the cognitive changes seen in dementia: the hippocampus, piriform/entorhinal cortex, and amygdala. The ventricles were also enlarged.

“These results revealed an important role of ApoE in regulating tau-mediated neurodegeneration, with ApoE4 causing more severe damage and the absence of ApoE being protective,” the investigators wrote.

The E4/tau tango started early, too, the team noted. At 3 months old, tau-E4 mice had no obvious brain atrophy, but already had significantly more soluble tau than did any of the other strains. By 9 months, when tauopathy was obvious, the tau-E4 mice still had more of the protein, which had shifted from a soluble to an insoluble and hyperphosphorylated state. The tau-E4 mice didn’t appear to be making more tau than the others, though; rather, they were less able to clear it through the neurons’ clearing and recycling system of autophagy.

Drilling down further into the neurons’ pathophysiology, the team found that tau first appeared in the axons of dentate gyrus granule cells in the hippocampus, and then, at an early age, moved into the cell body. Again, there were APOE allele–specific patterns to tau propagation. The team saw four major tau staining patterns, which correlated with the level of brain atrophy. Types 1 and 2, associated with least atrophy, occurred most often in the tau-only, ApoE-negative mice; type 4, associated with the greatest atrophy, occurred most often in the tau-E4 mice.

“The featured distribution of these ... patterns, which either represent different tau structures or progressively more advanced pathological tau stages, indicate ApoE affects either tau conformation or tau pathology progression,” the investigators wrote.
 

Greatest neurodegeneration seen with ApoE4

Tau-mediated neurodegeneration initiated levels of inflammatory response that also depended on the type of ApoE isoform. Exposure to a culture of damaged neurons and mixed glial cells caused microglia to release a flood of inflammatory cytokines that called in a host of astrocytes to kill damaged tau-E4 neurons en masse, but attacked the tau-E3, tau-E2, and tau-only strains much less. This finding indicates that “ApoE itself was directly involved in inducing neurotoxicity in tau-expressing susceptible neurons,” the team wrote.

Finally, they investigated this model of neurodegeneration in postmortem brain samples of patients with corticobasal degeneration, Pick disease, and progressive supranuclear palsy – the three most common sporadic primary tauopathies. Patients with the E4 allele showed more severe neurodegeneration and a greater interaction of tau pathology and neurodegeneration. Amyloid deposition was associated with less severe neurodegeneration.

Taken together, the findings strongly suggest that the high-risk APOE4 allele is the linchpin that links neuroinflammation to neuronal death in the setting of tau pathology, the investigators concluded.

“The presence of degenerating neurons appeared to further induce neuroinflammation, which was augmented by ApoE4 owing to its inherently higher innate immune reactivity. While activated microglia may be protective to some extent in the setting of amyloid-beta pathology, by targeting plaques and reducing dystrophic neurites, they could be deleterious in tauopathy by directly targeting injured neurons and by activating toxic astrocytes. Enhanced neuroinflammation associated with ApoE4 may further exacerbate neurodegeneration.”

The study was funded by grants awarded to multiple investigators by the National Institutes of Health, the JPB Foundation, Cure Alzheimer’s Fund, AstraZeneca, the Consortium for Frontotemporal Dementia Research, the Tau Consortium, the National Multiple Sclerosis Society, the Nancy Davis Foundation, and the Amyotrophic Lateral Sclerosis Association. Dr. Holtzman cofounded and is on the scientific advisory board of C2N Diagnostics. He consults for Genentech, AbbVie, Eli Lilly, Proclara, GlaxoSmithKline, and Denali. Dr. Holtzman’s lab is funded by institutional research grants from C2N Diagnostics, Eli Lilly, AbbVie, and Denali.

[email protected]

On Twitter @Alz_Gal

The U.S. House of Representatives has passed legislation that would ban abortions starting at 20 weeks.

This isn’t the first time in recent years that the Republican-controlled House has passed a 20-week ban. What’s different this time is that it has the support of the White House. Despite the Trump administration’s support for the bill, it’s unlikely to garner the support necessary to come up for a vote in the U.S. Senate.

Alicia Ault/Frontline Medical News

[email protected]

On Twitter @maryellenny

The U.S. House of Representatives has passed legislation that would ban abortions starting at 20 weeks.

This isn’t the first time in recent years that the Republican-controlled House has passed a 20-week ban. What’s different this time is that it has the support of the White House. Despite the Trump administration’s support for the bill, it’s unlikely to garner the support necessary to come up for a vote in the U.S. Senate.

Alicia Ault/Frontline Medical News

[email protected]

On Twitter @maryellenny

The U.S. House of Representatives has passed legislation that would ban abortions starting at 20 weeks.

This isn’t the first time in recent years that the Republican-controlled House has passed a 20-week ban. What’s different this time is that it has the support of the White House. Despite the Trump administration’s support for the bill, it’s unlikely to garner the support necessary to come up for a vote in the U.S. Senate.

Alicia Ault/Frontline Medical News

[email protected]

On Twitter @maryellenny

Nearly all states now have a prescription drug monitoring program (PDMP) that requires physicians to report patient data and track patient histories before prescribing controlled substances, but who is watching to ensure such reporting occurs, and what can happen if physicians fail to check the database?

The answer depends on the state.

The agencies that monitor state PDMPs vary from medical boards or health departments to pharmacy boards and law enforcement agencies. How and when the data can be accessed and by whom depends on the jurisdiction.

Case law shapes PDMP access

Recent court rulings also are shaping when PDMP data can be accessed and how physicians can come under the radar of state and federal authorities.

For example, the California Supreme Court ruled in June that a medical board was justified in obtaining a physician’s prescription records through the state’s PDMP without a warrant or subpoena. The case started when a patient made a complaint against Burbank, Calif.–based internist Alwin Carl Lewis, MD, regarding medical advice he offered her about losing weight. The complaint was not related to the prescribing of controlled substances. During the course of the investigation, a Medical Board of California investigator obtained a prescriber report on Dr. Lewis from the state’s CURES database, which contained prescription information for hundreds of his patients.

As a result of the investigation, the medical board charged Dr. Lewis with several violations related to the original patient who complained, as well as five additional patients who were prescribed controlled substances. Charges included unprofessional conduct, prescribing dangerous drugs without an appropriate examination, excessive prescribing, and failure to maintain adequate and accurate medical records, according to court documents.

Dr. Lewis sued the state, arguing that the medical board violated his patients’ privacy rights by obtaining the CURES reports without a warrant, subpoena, or good cause. A lower court found in favor of the board and the state supreme court agreed, ruling the government’s need to protect public safety outweighed any intrusion into privacy.

A similar decision was recently issued in Oregon when the 9th U.S. Circuit Court of Appeals ruled that the federal Drug Enforcement Administration (DEA) does not need a warrant to subpoena prescription drug information from Oregon’s PDMP.

In that case, the DEA sought patient-specific information from Oregon’s PDMP through the use of a federal administrative subpoena, which does not involve judicial review or a showing of probable cause. The Oregon PDMP refused to comply on the grounds that doing so violates Oregon state law, which requires a court order based on probable cause before patient data in the PDMP can be disclosed. Oregon internist James Roe, MD, and several patients sued the DEA, arguing that the request violated patient privacy rights, but the appeals court in June ruled that federal law that grants subpoena power to the agency trumps Oregon law, which requires a court order.

In a court brief, the American Medical Association and eight other medical associations expressed concern that allowing the DEA access to PDMP records without a court order violates patient privacy and jeopardizes the integrity of the patient-physician relationship.

“To the extent that the Drug Enforcement Administration asserts an unfettered right to access data from the PDMP without probable cause or judicial oversight and approval, that not only takes improper advantage of the health care data system – which by its terms in Oregon prohibits such access – but undermines the health care purposes that the state PDMPs were set up to serve,” the associations stated in a court brief.
 

PDMP violations – what happens next?

Failing to register, report to, or check your state’s PDMP can result in a license suspension, disciplinary action by a state agency, or potential criminal charges if the violation is serious enough.

“Their license is at stake, [and] their business is at stake,” Ms. Mazina said. “Overprescribing [and] overdispensing is the number one reason for administrative actions.”

Physicians also may face civil fines for failing to register with their state PDMP or for violating program regulations. In Kentucky, for example, doctors can be fined $250 for each prescription written while the doctor is not properly registered. In Maine, prescribers and dispensers face a civil fine of up to $5,000 for violating PDMP rules. Violations that lead to criminal investigations also may result in arrest or prosecution by federal authorities.

Education is key to avoiding PDMP penalties and ensuring compliance with state rules, Ms. Mazina stressed. Learn your state’s PDMP regulations, ensure staff members are trained on the proper protocols, and keep up to date on changes.

[email protected] On Twitter @legal_med

Nearly all states now have a prescription drug monitoring program (PDMP) that requires physicians to report patient data and track patient histories before prescribing controlled substances, but who is watching to ensure such reporting occurs, and what can happen if physicians fail to check the database?

The answer depends on the state.

The agencies that monitor state PDMPs vary from medical boards or health departments to pharmacy boards and law enforcement agencies. How and when the data can be accessed and by whom depends on the jurisdiction.

Case law shapes PDMP access

Recent court rulings also are shaping when PDMP data can be accessed and how physicians can come under the radar of state and federal authorities.

For example, the California Supreme Court ruled in June that a medical board was justified in obtaining a physician’s prescription records through the state’s PDMP without a warrant or subpoena. The case started when a patient made a complaint against Burbank, Calif.–based internist Alwin Carl Lewis, MD, regarding medical advice he offered her about losing weight. The complaint was not related to the prescribing of controlled substances. During the course of the investigation, a Medical Board of California investigator obtained a prescriber report on Dr. Lewis from the state’s CURES database, which contained prescription information for hundreds of his patients.

As a result of the investigation, the medical board charged Dr. Lewis with several violations related to the original patient who complained, as well as five additional patients who were prescribed controlled substances. Charges included unprofessional conduct, prescribing dangerous drugs without an appropriate examination, excessive prescribing, and failure to maintain adequate and accurate medical records, according to court documents.

Dr. Lewis sued the state, arguing that the medical board violated his patients’ privacy rights by obtaining the CURES reports without a warrant, subpoena, or good cause. A lower court found in favor of the board and the state supreme court agreed, ruling the government’s need to protect public safety outweighed any intrusion into privacy.

A similar decision was recently issued in Oregon when the 9th U.S. Circuit Court of Appeals ruled that the federal Drug Enforcement Administration (DEA) does not need a warrant to subpoena prescription drug information from Oregon’s PDMP.

In that case, the DEA sought patient-specific information from Oregon’s PDMP through the use of a federal administrative subpoena, which does not involve judicial review or a showing of probable cause. The Oregon PDMP refused to comply on the grounds that doing so violates Oregon state law, which requires a court order based on probable cause before patient data in the PDMP can be disclosed. Oregon internist James Roe, MD, and several patients sued the DEA, arguing that the request violated patient privacy rights, but the appeals court in June ruled that federal law that grants subpoena power to the agency trumps Oregon law, which requires a court order.

In a court brief, the American Medical Association and eight other medical associations expressed concern that allowing the DEA access to PDMP records without a court order violates patient privacy and jeopardizes the integrity of the patient-physician relationship.

“To the extent that the Drug Enforcement Administration asserts an unfettered right to access data from the PDMP without probable cause or judicial oversight and approval, that not only takes improper advantage of the health care data system – which by its terms in Oregon prohibits such access – but undermines the health care purposes that the state PDMPs were set up to serve,” the associations stated in a court brief.
 

PDMP violations – what happens next?

Failing to register, report to, or check your state’s PDMP can result in a license suspension, disciplinary action by a state agency, or potential criminal charges if the violation is serious enough.

“Their license is at stake, [and] their business is at stake,” Ms. Mazina said. “Overprescribing [and] overdispensing is the number one reason for administrative actions.”

Physicians also may face civil fines for failing to register with their state PDMP or for violating program regulations. In Kentucky, for example, doctors can be fined $250 for each prescription written while the doctor is not properly registered. In Maine, prescribers and dispensers face a civil fine of up to $5,000 for violating PDMP rules. Violations that lead to criminal investigations also may result in arrest or prosecution by federal authorities.

Education is key to avoiding PDMP penalties and ensuring compliance with state rules, Ms. Mazina stressed. Learn your state’s PDMP regulations, ensure staff members are trained on the proper protocols, and keep up to date on changes.

[email protected] On Twitter @legal_med

Nearly all states now have a prescription drug monitoring program (PDMP) that requires physicians to report patient data and track patient histories before prescribing controlled substances, but who is watching to ensure such reporting occurs, and what can happen if physicians fail to check the database?

The answer depends on the state.

The agencies that monitor state PDMPs vary from medical boards or health departments to pharmacy boards and law enforcement agencies. How and when the data can be accessed and by whom depends on the jurisdiction.

Case law shapes PDMP access

Recent court rulings also are shaping when PDMP data can be accessed and how physicians can come under the radar of state and federal authorities.

For example, the California Supreme Court ruled in June that a medical board was justified in obtaining a physician’s prescription records through the state’s PDMP without a warrant or subpoena. The case started when a patient made a complaint against Burbank, Calif.–based internist Alwin Carl Lewis, MD, regarding medical advice he offered her about losing weight. The complaint was not related to the prescribing of controlled substances. During the course of the investigation, a Medical Board of California investigator obtained a prescriber report on Dr. Lewis from the state’s CURES database, which contained prescription information for hundreds of his patients.

As a result of the investigation, the medical board charged Dr. Lewis with several violations related to the original patient who complained, as well as five additional patients who were prescribed controlled substances. Charges included unprofessional conduct, prescribing dangerous drugs without an appropriate examination, excessive prescribing, and failure to maintain adequate and accurate medical records, according to court documents.

Dr. Lewis sued the state, arguing that the medical board violated his patients’ privacy rights by obtaining the CURES reports without a warrant, subpoena, or good cause. A lower court found in favor of the board and the state supreme court agreed, ruling the government’s need to protect public safety outweighed any intrusion into privacy.

A similar decision was recently issued in Oregon when the 9th U.S. Circuit Court of Appeals ruled that the federal Drug Enforcement Administration (DEA) does not need a warrant to subpoena prescription drug information from Oregon’s PDMP.

In that case, the DEA sought patient-specific information from Oregon’s PDMP through the use of a federal administrative subpoena, which does not involve judicial review or a showing of probable cause. The Oregon PDMP refused to comply on the grounds that doing so violates Oregon state law, which requires a court order based on probable cause before patient data in the PDMP can be disclosed. Oregon internist James Roe, MD, and several patients sued the DEA, arguing that the request violated patient privacy rights, but the appeals court in June ruled that federal law that grants subpoena power to the agency trumps Oregon law, which requires a court order.

In a court brief, the American Medical Association and eight other medical associations expressed concern that allowing the DEA access to PDMP records without a court order violates patient privacy and jeopardizes the integrity of the patient-physician relationship.

“To the extent that the Drug Enforcement Administration asserts an unfettered right to access data from the PDMP without probable cause or judicial oversight and approval, that not only takes improper advantage of the health care data system – which by its terms in Oregon prohibits such access – but undermines the health care purposes that the state PDMPs were set up to serve,” the associations stated in a court brief.
 

PDMP violations – what happens next?

Failing to register, report to, or check your state’s PDMP can result in a license suspension, disciplinary action by a state agency, or potential criminal charges if the violation is serious enough.

“Their license is at stake, [and] their business is at stake,” Ms. Mazina said. “Overprescribing [and] overdispensing is the number one reason for administrative actions.”

Physicians also may face civil fines for failing to register with their state PDMP or for violating program regulations. In Kentucky, for example, doctors can be fined $250 for each prescription written while the doctor is not properly registered. In Maine, prescribers and dispensers face a civil fine of up to $5,000 for violating PDMP rules. Violations that lead to criminal investigations also may result in arrest or prosecution by federal authorities.

Education is key to avoiding PDMP penalties and ensuring compliance with state rules, Ms. Mazina stressed. Learn your state’s PDMP regulations, ensure staff members are trained on the proper protocols, and keep up to date on changes.

[email protected] On Twitter @legal_med

When Wisconsin introduced its first prescription drug monitoring program (PDMP) system in 2013, doctors found the system clunky and cumbersome to navigate, recalled Noel Deep, MD, an Antigo, Wis.–based internist and president of the Wisconsin Medical Society.

Physicians had to click through several screens and were then directed to log into another website to enter patient information and scan records.

The state’s PDMP is much improved today, Dr. Deep said. The Wisconsin Department of Safety and Professional Services launched an enhanced version of the PDMP in January, giving doctors time to learn the new system before its use became mandatory for prescribers in April. The system takes fewer clicks and communicates with practices’ electronic medical record.

Beneficial or burdensome?

When Georgia legislators proposed a law earlier this year that would tighten reporting requirements for their state’s PDMP, physician leaders fought back against what they viewed as excessive regulations.

An initial bill included reporting requirements not only for standard controlled substances but for stimulants such as Adderall, Vyvanse, Focalin, and Ritalin, and all other nonopioid controlled drugs. The early version of the bill also recommended civil and criminal penalties for physicians who violated the regulations.

The American College of Physicians Georgia Chapter and the Medical Association of Georgia successfully advocated for the two provisions to be removed from the bill’s final version, said W. Cody McClatchey, MD, chair of the ACP Georgia Chapter’s health and public policy committee.

“We are in the midst of an opioid epidemic,” Dr. McClatchey said in an interview. “It would have been unreasonable and costly for state government to mandate that prescribers check PDMP for controlled drugs not related to the opioid epidemic. [In addition], I felt strongly that prescribers should not be subject to criminal penalties for not checking the PDMP. We are already subject to civil and criminal penalties for intentionally or knowingly overprescribing controlled drugs. That is adequate protection for patients.”

Georgia’s law, signed in May, requires physicians and up to two certified staff to seek and review information from the PDMP every 90 days for any prescription outlined in the law that exceeds 3 days/26 pills for medical care, or 10 days/40 pills for surgical care. In addition, physicians must make a notation in the patient’s medical record stating the date and time upon which such inquiry was made, among other requirements.

‘Well-designed regs keep patients safe’

In California, prescribers are encouraged but not yet required to check the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing controlled substances. Under state law, checking the database will become mandatory 6 months after the California Department of Justice certifies that the CURES system is ready for statewide use and the department has adequate staff to handle the technical and administrative workload. When that will happen remains unclear.

It’s too early to know how well CURES will work once fully implemented, said Patricia Salber, MD, a Larkspur, Calif.–based internist and founder of the blog TheDoctorWeighsIn.com, but access to statewide data about patients’ medical and drug history is a positive for doctors.

“As a former emergency physician who has taken care of many drug-seeking patients, having access to statewide data about an individual’s drug use will be a valuable tool to help stem the tide of scheduled prescription drug abuse,” she said. “Given our mobile society, I would also like to eventually see a nationwide system.”

As new systems roll out, it’s important for physicians to give the databases a chance and advocate fixing the bugs, rather than condemning them because of logistics or initial glitches, Dr. Salber added.

Courtesy Dr. Pat Salber

Are PDMPs working?

Although PDMPs may be causing headaches for some, data show that they are having effective results against opioid abuse and overprescribing.

In Florida, opioid prescriptions decreased in 80% of counties from 2010 to 2015 after the state established a PDMP in combination with tighter regulation of pain clinics. In the first month after implementation of Florida’s PDMP, oxycodone deaths dropped by 25%, according to a 2015 study published in Drug and Alcohol Dependence (2015 May 1. doi: 10.1016/j.drugalcdep.2015.02.010).

Opioid prescriptions in Kentucky, New York, and Tennessee dropped after mandates that prescribers check their state PDMPs, according to a summary by the PDMP Center of Excellence at Brandeis University. In Kentucky, doses dispensed declined for hydrocodone (–10.3%), oxycodone (–11.6%), and oxymorphone (–35%), while in Tennessee the number of opioid prescriptions fell by 7%. In New York, total opioid prescriptions have dropped by more than 9% since the state’s PDMP went into effect.

In Wisconsin, an analysis after enactment of the state’s PDMP found a nearly 12% reduction in opioid prescriptions and a 13% reduction in opioid doses dispensed between the fourth quarter of 2015 and the fourth quarter of 2016, according to a report by the Wisconsin Department of Safety and Professional Services.

PDMPs also have altered physicians’ prescribing behaviors and changed patient care decisions, studies show. A review of medical providers in Ohio emergency departments found that 41% of those given PDMP data altered their prescribing for patients receiving multiple simultaneous narcotics prescriptions, according to the Brandeis University summary. Of those Ohio providers, 61% prescribed no narcotics or fewer narcotics than originally planned.

A survey of prescribers in Rhode Island and Connecticut found that those who used PDMP data were more likely than nonusers to take clinically appropriate action in response to suspected cases of prescription drug abuse or diversion by patients, such as conducting drug screens or referring them to substance abuse treatment.

Despite the positive impacts, however, challenges for PDMPs remain.

Dr. Deep noted that physicians in solo and small practices may have a harder time than employed physicians when it comes to checking databases, recording data, and delegating duties. In addition, differing PDMP regulations may not catch prescription drug abusers who go across state lines.

Most states with PDMPs share their PDMP data with other state PDMPs or share data with authorized users in other states. Florida can receive PDMP data from other jurisdictions and provide that data to authorized users in Florida, but it does not share its data with other states. Oregon allows only prescribers in California, Idaho, Nevada, and Washington state to access its database information.

PDMPs also are limited in what they tell physicians about patients, said Gregory A. Hood, MD, an internist in Lexington, Ky., and former governor of the American College of Physicians, Kentucky Chapter.

“PDMP is only helpful to a point,” he said in an interview. “Any PDMP has the inherent limitation that it only reports what is reported to it. This doesn’t tell us about whether the patient actually takes the medicine, gives or sells it away, or whether they use it appropriately or not. Patients can overuse for 3 of 4 weeks, buy a week on the street, or from someone they know, and we’re none the wiser, absent an informant.”

Kentucky’s database, called the Kentucky All Schedule Prescription Electronic Reporting System (KASPER), requires that prescribers and dispensers of controlled substances query the state’s electronic monitoring system before issuing new prescriptions or refills. To track illicit use of opiates, Kentucky also recently made gabapentin a Schedule V controlled substance, Dr. Hood said.

Whether PDMPs have a positive effect depends on what doctors do with the information they learn from the database, Dr. Hood said.

“Generally, PDMPs can help identify at least some who are seeking adverse gain,” he said. “Properly identifying someone with a medical issue and arranging proper care is a positive. Rote dropping of someone with a ‘dirty’ PDMP – as has been known to happen in some primary care and specialty offices – is difficult to view as a positive, particularly given shortages in both primary care and in pain management.”

[email protected] On Twitter @legal_med

When Wisconsin introduced its first prescription drug monitoring program (PDMP) system in 2013, doctors found the system clunky and cumbersome to navigate, recalled Noel Deep, MD, an Antigo, Wis.–based internist and president of the Wisconsin Medical Society.

Physicians had to click through several screens and were then directed to log into another website to enter patient information and scan records.

The state’s PDMP is much improved today, Dr. Deep said. The Wisconsin Department of Safety and Professional Services launched an enhanced version of the PDMP in January, giving doctors time to learn the new system before its use became mandatory for prescribers in April. The system takes fewer clicks and communicates with practices’ electronic medical record.

Beneficial or burdensome?

When Georgia legislators proposed a law earlier this year that would tighten reporting requirements for their state’s PDMP, physician leaders fought back against what they viewed as excessive regulations.

An initial bill included reporting requirements not only for standard controlled substances but for stimulants such as Adderall, Vyvanse, Focalin, and Ritalin, and all other nonopioid controlled drugs. The early version of the bill also recommended civil and criminal penalties for physicians who violated the regulations.

The American College of Physicians Georgia Chapter and the Medical Association of Georgia successfully advocated for the two provisions to be removed from the bill’s final version, said W. Cody McClatchey, MD, chair of the ACP Georgia Chapter’s health and public policy committee.

“We are in the midst of an opioid epidemic,” Dr. McClatchey said in an interview. “It would have been unreasonable and costly for state government to mandate that prescribers check PDMP for controlled drugs not related to the opioid epidemic. [In addition], I felt strongly that prescribers should not be subject to criminal penalties for not checking the PDMP. We are already subject to civil and criminal penalties for intentionally or knowingly overprescribing controlled drugs. That is adequate protection for patients.”

Georgia’s law, signed in May, requires physicians and up to two certified staff to seek and review information from the PDMP every 90 days for any prescription outlined in the law that exceeds 3 days/26 pills for medical care, or 10 days/40 pills for surgical care. In addition, physicians must make a notation in the patient’s medical record stating the date and time upon which such inquiry was made, among other requirements.

‘Well-designed regs keep patients safe’

In California, prescribers are encouraged but not yet required to check the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing controlled substances. Under state law, checking the database will become mandatory 6 months after the California Department of Justice certifies that the CURES system is ready for statewide use and the department has adequate staff to handle the technical and administrative workload. When that will happen remains unclear.

It’s too early to know how well CURES will work once fully implemented, said Patricia Salber, MD, a Larkspur, Calif.–based internist and founder of the blog TheDoctorWeighsIn.com, but access to statewide data about patients’ medical and drug history is a positive for doctors.

“As a former emergency physician who has taken care of many drug-seeking patients, having access to statewide data about an individual’s drug use will be a valuable tool to help stem the tide of scheduled prescription drug abuse,” she said. “Given our mobile society, I would also like to eventually see a nationwide system.”

As new systems roll out, it’s important for physicians to give the databases a chance and advocate fixing the bugs, rather than condemning them because of logistics or initial glitches, Dr. Salber added.

Courtesy Dr. Pat Salber

Are PDMPs working?

Although PDMPs may be causing headaches for some, data show that they are having effective results against opioid abuse and overprescribing.

In Florida, opioid prescriptions decreased in 80% of counties from 2010 to 2015 after the state established a PDMP in combination with tighter regulation of pain clinics. In the first month after implementation of Florida’s PDMP, oxycodone deaths dropped by 25%, according to a 2015 study published in Drug and Alcohol Dependence (2015 May 1. doi: 10.1016/j.drugalcdep.2015.02.010).

Opioid prescriptions in Kentucky, New York, and Tennessee dropped after mandates that prescribers check their state PDMPs, according to a summary by the PDMP Center of Excellence at Brandeis University. In Kentucky, doses dispensed declined for hydrocodone (–10.3%), oxycodone (–11.6%), and oxymorphone (–35%), while in Tennessee the number of opioid prescriptions fell by 7%. In New York, total opioid prescriptions have dropped by more than 9% since the state’s PDMP went into effect.

In Wisconsin, an analysis after enactment of the state’s PDMP found a nearly 12% reduction in opioid prescriptions and a 13% reduction in opioid doses dispensed between the fourth quarter of 2015 and the fourth quarter of 2016, according to a report by the Wisconsin Department of Safety and Professional Services.

PDMPs also have altered physicians’ prescribing behaviors and changed patient care decisions, studies show. A review of medical providers in Ohio emergency departments found that 41% of those given PDMP data altered their prescribing for patients receiving multiple simultaneous narcotics prescriptions, according to the Brandeis University summary. Of those Ohio providers, 61% prescribed no narcotics or fewer narcotics than originally planned.

A survey of prescribers in Rhode Island and Connecticut found that those who used PDMP data were more likely than nonusers to take clinically appropriate action in response to suspected cases of prescription drug abuse or diversion by patients, such as conducting drug screens or referring them to substance abuse treatment.

Despite the positive impacts, however, challenges for PDMPs remain.

Dr. Deep noted that physicians in solo and small practices may have a harder time than employed physicians when it comes to checking databases, recording data, and delegating duties. In addition, differing PDMP regulations may not catch prescription drug abusers who go across state lines.

Most states with PDMPs share their PDMP data with other state PDMPs or share data with authorized users in other states. Florida can receive PDMP data from other jurisdictions and provide that data to authorized users in Florida, but it does not share its data with other states. Oregon allows only prescribers in California, Idaho, Nevada, and Washington state to access its database information.

PDMPs also are limited in what they tell physicians about patients, said Gregory A. Hood, MD, an internist in Lexington, Ky., and former governor of the American College of Physicians, Kentucky Chapter.

“PDMP is only helpful to a point,” he said in an interview. “Any PDMP has the inherent limitation that it only reports what is reported to it. This doesn’t tell us about whether the patient actually takes the medicine, gives or sells it away, or whether they use it appropriately or not. Patients can overuse for 3 of 4 weeks, buy a week on the street, or from someone they know, and we’re none the wiser, absent an informant.”

Kentucky’s database, called the Kentucky All Schedule Prescription Electronic Reporting System (KASPER), requires that prescribers and dispensers of controlled substances query the state’s electronic monitoring system before issuing new prescriptions or refills. To track illicit use of opiates, Kentucky also recently made gabapentin a Schedule V controlled substance, Dr. Hood said.

Whether PDMPs have a positive effect depends on what doctors do with the information they learn from the database, Dr. Hood said.

“Generally, PDMPs can help identify at least some who are seeking adverse gain,” he said. “Properly identifying someone with a medical issue and arranging proper care is a positive. Rote dropping of someone with a ‘dirty’ PDMP – as has been known to happen in some primary care and specialty offices – is difficult to view as a positive, particularly given shortages in both primary care and in pain management.”

[email protected] On Twitter @legal_med

When Wisconsin introduced its first prescription drug monitoring program (PDMP) system in 2013, doctors found the system clunky and cumbersome to navigate, recalled Noel Deep, MD, an Antigo, Wis.–based internist and president of the Wisconsin Medical Society.

Physicians had to click through several screens and were then directed to log into another website to enter patient information and scan records.

The state’s PDMP is much improved today, Dr. Deep said. The Wisconsin Department of Safety and Professional Services launched an enhanced version of the PDMP in January, giving doctors time to learn the new system before its use became mandatory for prescribers in April. The system takes fewer clicks and communicates with practices’ electronic medical record.

Beneficial or burdensome?

When Georgia legislators proposed a law earlier this year that would tighten reporting requirements for their state’s PDMP, physician leaders fought back against what they viewed as excessive regulations.

An initial bill included reporting requirements not only for standard controlled substances but for stimulants such as Adderall, Vyvanse, Focalin, and Ritalin, and all other nonopioid controlled drugs. The early version of the bill also recommended civil and criminal penalties for physicians who violated the regulations.

The American College of Physicians Georgia Chapter and the Medical Association of Georgia successfully advocated for the two provisions to be removed from the bill’s final version, said W. Cody McClatchey, MD, chair of the ACP Georgia Chapter’s health and public policy committee.

“We are in the midst of an opioid epidemic,” Dr. McClatchey said in an interview. “It would have been unreasonable and costly for state government to mandate that prescribers check PDMP for controlled drugs not related to the opioid epidemic. [In addition], I felt strongly that prescribers should not be subject to criminal penalties for not checking the PDMP. We are already subject to civil and criminal penalties for intentionally or knowingly overprescribing controlled drugs. That is adequate protection for patients.”

Georgia’s law, signed in May, requires physicians and up to two certified staff to seek and review information from the PDMP every 90 days for any prescription outlined in the law that exceeds 3 days/26 pills for medical care, or 10 days/40 pills for surgical care. In addition, physicians must make a notation in the patient’s medical record stating the date and time upon which such inquiry was made, among other requirements.

‘Well-designed regs keep patients safe’

In California, prescribers are encouraged but not yet required to check the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing controlled substances. Under state law, checking the database will become mandatory 6 months after the California Department of Justice certifies that the CURES system is ready for statewide use and the department has adequate staff to handle the technical and administrative workload. When that will happen remains unclear.

It’s too early to know how well CURES will work once fully implemented, said Patricia Salber, MD, a Larkspur, Calif.–based internist and founder of the blog TheDoctorWeighsIn.com, but access to statewide data about patients’ medical and drug history is a positive for doctors.

“As a former emergency physician who has taken care of many drug-seeking patients, having access to statewide data about an individual’s drug use will be a valuable tool to help stem the tide of scheduled prescription drug abuse,” she said. “Given our mobile society, I would also like to eventually see a nationwide system.”

As new systems roll out, it’s important for physicians to give the databases a chance and advocate fixing the bugs, rather than condemning them because of logistics or initial glitches, Dr. Salber added.

Courtesy Dr. Pat Salber

Are PDMPs working?

Although PDMPs may be causing headaches for some, data show that they are having effective results against opioid abuse and overprescribing.

In Florida, opioid prescriptions decreased in 80% of counties from 2010 to 2015 after the state established a PDMP in combination with tighter regulation of pain clinics. In the first month after implementation of Florida’s PDMP, oxycodone deaths dropped by 25%, according to a 2015 study published in Drug and Alcohol Dependence (2015 May 1. doi: 10.1016/j.drugalcdep.2015.02.010).

Opioid prescriptions in Kentucky, New York, and Tennessee dropped after mandates that prescribers check their state PDMPs, according to a summary by the PDMP Center of Excellence at Brandeis University. In Kentucky, doses dispensed declined for hydrocodone (–10.3%), oxycodone (–11.6%), and oxymorphone (–35%), while in Tennessee the number of opioid prescriptions fell by 7%. In New York, total opioid prescriptions have dropped by more than 9% since the state’s PDMP went into effect.

In Wisconsin, an analysis after enactment of the state’s PDMP found a nearly 12% reduction in opioid prescriptions and a 13% reduction in opioid doses dispensed between the fourth quarter of 2015 and the fourth quarter of 2016, according to a report by the Wisconsin Department of Safety and Professional Services.

PDMPs also have altered physicians’ prescribing behaviors and changed patient care decisions, studies show. A review of medical providers in Ohio emergency departments found that 41% of those given PDMP data altered their prescribing for patients receiving multiple simultaneous narcotics prescriptions, according to the Brandeis University summary. Of those Ohio providers, 61% prescribed no narcotics or fewer narcotics than originally planned.

A survey of prescribers in Rhode Island and Connecticut found that those who used PDMP data were more likely than nonusers to take clinically appropriate action in response to suspected cases of prescription drug abuse or diversion by patients, such as conducting drug screens or referring them to substance abuse treatment.

Despite the positive impacts, however, challenges for PDMPs remain.

Dr. Deep noted that physicians in solo and small practices may have a harder time than employed physicians when it comes to checking databases, recording data, and delegating duties. In addition, differing PDMP regulations may not catch prescription drug abusers who go across state lines.

Most states with PDMPs share their PDMP data with other state PDMPs or share data with authorized users in other states. Florida can receive PDMP data from other jurisdictions and provide that data to authorized users in Florida, but it does not share its data with other states. Oregon allows only prescribers in California, Idaho, Nevada, and Washington state to access its database information.

PDMPs also are limited in what they tell physicians about patients, said Gregory A. Hood, MD, an internist in Lexington, Ky., and former governor of the American College of Physicians, Kentucky Chapter.

“PDMP is only helpful to a point,” he said in an interview. “Any PDMP has the inherent limitation that it only reports what is reported to it. This doesn’t tell us about whether the patient actually takes the medicine, gives or sells it away, or whether they use it appropriately or not. Patients can overuse for 3 of 4 weeks, buy a week on the street, or from someone they know, and we’re none the wiser, absent an informant.”

Kentucky’s database, called the Kentucky All Schedule Prescription Electronic Reporting System (KASPER), requires that prescribers and dispensers of controlled substances query the state’s electronic monitoring system before issuing new prescriptions or refills. To track illicit use of opiates, Kentucky also recently made gabapentin a Schedule V controlled substance, Dr. Hood said.

Whether PDMPs have a positive effect depends on what doctors do with the information they learn from the database, Dr. Hood said.

“Generally, PDMPs can help identify at least some who are seeking adverse gain,” he said. “Properly identifying someone with a medical issue and arranging proper care is a positive. Rote dropping of someone with a ‘dirty’ PDMP – as has been known to happen in some primary care and specialty offices – is difficult to view as a positive, particularly given shortages in both primary care and in pain management.”

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