Clinical Neurology News

Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

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Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Patients with hypertension who show substantial progression of cerebral small vessel disease have a sixfold higher odds of developing mild cognitive impairment compared with similar patients who do not have signs of progression. Also today, antidepressants are tied to greater hip fracture incidence, a hospital readmission reduction program may be doing more harm than good, and the flu season rages on with 19 states showing high activity in the final week of 2018.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Cladribine tablets (3.5 mg/kg) have a favorable adverse event profile and are safe as monotherapy for relapsing remitting multiple sclerosis, according to an integrated analysis of several clinical trials published in Multiple Sclerosis and Related Disorders.

The drug causes transient lymphopenia, as is to be expected from its mechanism of action, but most patients who receive cladribine do not have grade 3 or 4 lymphopenia, the authors wrote. In general, cladribine is not associated with an increased risk of infections or malignancy.

Data indicate that cladribine’s mechanism of action contributes to its durable clinical effect, despite the brief treatment periods. Clinical trials have provided information about the treatment’s safety and tolerability. To examine the treatment’s long-term safety, Stuart Cook, MD, of New Jersey Medical School, Newark, and his colleagues pooled data for patients with multiple sclerosis (MS) treated with cladribine tablets (3.5 mg/kg) as monotherapy or placebo in three phase 3 clinical trials (CLARITY, CLARITY Extension, and ORACLE-MS) and followed up in the PREMIERE registry. The investigators called these patients the monotherapy oral cohort.

To investigate the potential associations between cladribine and rarer adverse events such as malignancies, Dr. Cook and his colleagues examined data from patients with MS who received cladribine, regardless of the formulation or route of administration, or placebo (the all-exposed cohort). This cohort included data from the ONWARD trial, in which patients received cladribine tablets or placebo in combination with interferon-beta, as well as data from five trials in which patients received parenteral cladribine or placebo.

The monotherapy oral cohort included 923 patients who received cladribine and 641 who received placebo. The median age at enrollment in this cohort was approximately 36 years. The majority of patients were women and disease characteristics were balanced between arms. The all-exposed cohort included 1,926 patients who received cladribine and 802 who received placebo. The demographic characteristics of this cohort were similar to those of the monotherapy oral cohort.

In the monotherapy oral cohort, the incidence rate of treatment-emergent adverse events, in adjusted adverse events per 100 patient-years, was 103.29 for the active group versus 94.26 for controls. Lymphopenia (7.94 vs. 1.06) and decreased lymphocyte count (0.78 vs. 0.10) occurred more frequently in the active group than in the placebo group.

Herpes zoster also occurred more frequently in the cladribine group (0.83 vs. 0.20). However, cladribine was not associated with systemic serious disseminated herpes zoster. Furthermore, the investigators found no overall increased risk of infections, including opportunistic infections, with cladribine tablets versus placebo, except for herpes zoster.

In addition, Dr. Cook and his colleagues found no increase in malignancy rates among patients who received cladribine, compared with those who received placebo. They also found no increase in the incidence of malignancies over time in the cladribine group.

The adverse event profile for cladribine tablets (3.5 mg/kg) as monotherapy has been well characterized, the investigators wrote. The results of this analysis are broadly similar to the short-term adverse event results reported in the individual trials.

EMD Serono and Merck Serono, two affiliates of Merck in Darmstadt, Germany, sponsored the study. Merck manufactures cladribine.

egreb@mdedge.com

SOURCE: Cook S et al. Mult Scler Relat Disord. 2018 Nov 18. doi: 10.1016/j.msard.2018.11.021.

Cladribine tablets (3.5 mg/kg) have a favorable adverse event profile and are safe as monotherapy for relapsing remitting multiple sclerosis, according to an integrated analysis of several clinical trials published in Multiple Sclerosis and Related Disorders.

The drug causes transient lymphopenia, as is to be expected from its mechanism of action, but most patients who receive cladribine do not have grade 3 or 4 lymphopenia, the authors wrote. In general, cladribine is not associated with an increased risk of infections or malignancy.

Data indicate that cladribine’s mechanism of action contributes to its durable clinical effect, despite the brief treatment periods. Clinical trials have provided information about the treatment’s safety and tolerability. To examine the treatment’s long-term safety, Stuart Cook, MD, of New Jersey Medical School, Newark, and his colleagues pooled data for patients with multiple sclerosis (MS) treated with cladribine tablets (3.5 mg/kg) as monotherapy or placebo in three phase 3 clinical trials (CLARITY, CLARITY Extension, and ORACLE-MS) and followed up in the PREMIERE registry. The investigators called these patients the monotherapy oral cohort.

To investigate the potential associations between cladribine and rarer adverse events such as malignancies, Dr. Cook and his colleagues examined data from patients with MS who received cladribine, regardless of the formulation or route of administration, or placebo (the all-exposed cohort). This cohort included data from the ONWARD trial, in which patients received cladribine tablets or placebo in combination with interferon-beta, as well as data from five trials in which patients received parenteral cladribine or placebo.

The monotherapy oral cohort included 923 patients who received cladribine and 641 who received placebo. The median age at enrollment in this cohort was approximately 36 years. The majority of patients were women and disease characteristics were balanced between arms. The all-exposed cohort included 1,926 patients who received cladribine and 802 who received placebo. The demographic characteristics of this cohort were similar to those of the monotherapy oral cohort.

In the monotherapy oral cohort, the incidence rate of treatment-emergent adverse events, in adjusted adverse events per 100 patient-years, was 103.29 for the active group versus 94.26 for controls. Lymphopenia (7.94 vs. 1.06) and decreased lymphocyte count (0.78 vs. 0.10) occurred more frequently in the active group than in the placebo group.

Herpes zoster also occurred more frequently in the cladribine group (0.83 vs. 0.20). However, cladribine was not associated with systemic serious disseminated herpes zoster. Furthermore, the investigators found no overall increased risk of infections, including opportunistic infections, with cladribine tablets versus placebo, except for herpes zoster.

In addition, Dr. Cook and his colleagues found no increase in malignancy rates among patients who received cladribine, compared with those who received placebo. They also found no increase in the incidence of malignancies over time in the cladribine group.

The adverse event profile for cladribine tablets (3.5 mg/kg) as monotherapy has been well characterized, the investigators wrote. The results of this analysis are broadly similar to the short-term adverse event results reported in the individual trials.

EMD Serono and Merck Serono, two affiliates of Merck in Darmstadt, Germany, sponsored the study. Merck manufactures cladribine.

egreb@mdedge.com

SOURCE: Cook S et al. Mult Scler Relat Disord. 2018 Nov 18. doi: 10.1016/j.msard.2018.11.021.

Cladribine tablets (3.5 mg/kg) have a favorable adverse event profile and are safe as monotherapy for relapsing remitting multiple sclerosis, according to an integrated analysis of several clinical trials published in Multiple Sclerosis and Related Disorders.

The drug causes transient lymphopenia, as is to be expected from its mechanism of action, but most patients who receive cladribine do not have grade 3 or 4 lymphopenia, the authors wrote. In general, cladribine is not associated with an increased risk of infections or malignancy.

Data indicate that cladribine’s mechanism of action contributes to its durable clinical effect, despite the brief treatment periods. Clinical trials have provided information about the treatment’s safety and tolerability. To examine the treatment’s long-term safety, Stuart Cook, MD, of New Jersey Medical School, Newark, and his colleagues pooled data for patients with multiple sclerosis (MS) treated with cladribine tablets (3.5 mg/kg) as monotherapy or placebo in three phase 3 clinical trials (CLARITY, CLARITY Extension, and ORACLE-MS) and followed up in the PREMIERE registry. The investigators called these patients the monotherapy oral cohort.

To investigate the potential associations between cladribine and rarer adverse events such as malignancies, Dr. Cook and his colleagues examined data from patients with MS who received cladribine, regardless of the formulation or route of administration, or placebo (the all-exposed cohort). This cohort included data from the ONWARD trial, in which patients received cladribine tablets or placebo in combination with interferon-beta, as well as data from five trials in which patients received parenteral cladribine or placebo.

The monotherapy oral cohort included 923 patients who received cladribine and 641 who received placebo. The median age at enrollment in this cohort was approximately 36 years. The majority of patients were women and disease characteristics were balanced between arms. The all-exposed cohort included 1,926 patients who received cladribine and 802 who received placebo. The demographic characteristics of this cohort were similar to those of the monotherapy oral cohort.

In the monotherapy oral cohort, the incidence rate of treatment-emergent adverse events, in adjusted adverse events per 100 patient-years, was 103.29 for the active group versus 94.26 for controls. Lymphopenia (7.94 vs. 1.06) and decreased lymphocyte count (0.78 vs. 0.10) occurred more frequently in the active group than in the placebo group.

Herpes zoster also occurred more frequently in the cladribine group (0.83 vs. 0.20). However, cladribine was not associated with systemic serious disseminated herpes zoster. Furthermore, the investigators found no overall increased risk of infections, including opportunistic infections, with cladribine tablets versus placebo, except for herpes zoster.

In addition, Dr. Cook and his colleagues found no increase in malignancy rates among patients who received cladribine, compared with those who received placebo. They also found no increase in the incidence of malignancies over time in the cladribine group.

The adverse event profile for cladribine tablets (3.5 mg/kg) as monotherapy has been well characterized, the investigators wrote. The results of this analysis are broadly similar to the short-term adverse event results reported in the individual trials.

EMD Serono and Merck Serono, two affiliates of Merck in Darmstadt, Germany, sponsored the study. Merck manufactures cladribine.

egreb@mdedge.com

SOURCE: Cook S et al. Mult Scler Relat Disord. 2018 Nov 18. doi: 10.1016/j.msard.2018.11.021.

New federal statistics suggest that the opioid epidemic in the United States is evolving as physicians crack down on the use of prescription painkillers: Fatal drug overdose deaths rose by 12% from 2016 to 2017, boosted by a wave of fatalities linked to illicit synthetic opioids like fentanyl that are now linked to an estimated 60% of opioid-related deaths.

US DEA

“Overall, the overdose epidemic continues to worsen, and it has grown increasingly complex by coinvolvement of prescription and illicit drugs,” Lawrence Scholl, PhD, MPH, and his associates at the Centers for Disease Control & Prevention wrote in the Morbidity and Mortality Weekly Report.

The new statistics provide more evidence that 2017 marked “a sharp increase in what has characterized as the third wave of the opioid epidemic,” said drug and health policy researcher Stephen Crystal, PhD, of Rutgers University, New Brunswick, N.J., in an interview. He was referring to a wave that experts believe started in 2013 amid a spike in U.S. overdose deaths from fentanyl and other synthetic opioids.

The new report analyzes fatal drug overdose data from 2013 to 2017. According to the findings, the total number of those overdoses rose to 70,237 in 2017, up from 63,632 in 2016. The highest drug overdose death rates in 2017 were in West Virginia, followed by Ohio, Pennsylvania, and the District of Columbia.

Some statistics did not change much from 2016 to 2017: About two-thirds of the drug overdose deaths were linked to opioids in both years, and the death rate of cases linked to prescription drugs and heroin remained steady. (Death rates in the report were age adjusted.)

However, the percentage of fatal overdose cases linked to synthetic opioids grew 45% from 2016 to 2017. Overall, 60% of opioid-related fatal overdoses in 2017 involved synthetic opioids.

The report identifies increases in several areas from 2016 to 2017. Opioid-related drug overdose deaths among black people rose by 25%, and an analysis of data from 34 states and the District of Columbia found the highest increases in death rates in North Carolina (29%), Ohio (19%), and Maine (19%).

In regard to deaths linked to synthetic opioids specifically, the highest death rates in 2017 were in West Virginia (37 per 100,000), Ohio (32 per 100,000), and New Hampshire (30 per 100,000).

“Part of what we’re seeing in these increased numbers are individuals who have pain, can’t get prescribed opioids, and turn to street drugs,” Dr. Crystal said, adding that “abruptly cutting patients off is not good, and leaving patients with a lot of untreated pain is not good. If people are going to be discontinued [from opioids] or have their doses reduced, the taper needs to be done very slowly and carefully.”

Synthetic opioids were not the only drugs that are driving up fatal overdoses, as the death rates of cases linked to cocaine and psychostimulants (such as methamphetamine) jumped by more than a third in 2017.

“The most important thing these numbers are telling me is that it’s becoming more and more attractive to drug dealers to put fentanyl in the heroin, cocaine, and other drugs they sell,” Dr. Crystal said. “When that happens, dependence on street drugs becomes much more deadly. It’s almost impossible to get the dose right. Every time you shoot up, you’re taking a chance that you’ll overdose.”

The report had limitations, including the fact that details about drug use were missing from 12% (2016) and 15% (2017) of death certificates in fatal overdose cases. By state, the percentages of those death certificates that included drug information ranged from as little as 55% to 99%.

There’s some possible positive news: The report points to preliminary data from 2018 suggesting that the number of annual drug overdose deaths may be leveling off – although it says more analysis is needed to confirm the trend.

Dr. Crystal, however, is not celebrating. “I don’t see this as a good news story, really,” he said, adding that there’s “a little too much of people patting themselves on the back” because they’re proud of cutbacks in opioid prescriptions.

“This doesn’t have to do with the huge number of people who got started with opioids years ago” and are now at risk of using street drugs, he said. “We haven’t engaged that population at the rate we need to. And flattening out at 70,000 drug overdoses a year is not a good news story.”

Dr. Crystal reported no relevant disclosures.

SOURCE: Scholl L et al. MMWR. 2019 Jan 4;67(5152):1419-27.

New federal statistics suggest that the opioid epidemic in the United States is evolving as physicians crack down on the use of prescription painkillers: Fatal drug overdose deaths rose by 12% from 2016 to 2017, boosted by a wave of fatalities linked to illicit synthetic opioids like fentanyl that are now linked to an estimated 60% of opioid-related deaths.

US DEA

“Overall, the overdose epidemic continues to worsen, and it has grown increasingly complex by coinvolvement of prescription and illicit drugs,” Lawrence Scholl, PhD, MPH, and his associates at the Centers for Disease Control & Prevention wrote in the Morbidity and Mortality Weekly Report.

The new statistics provide more evidence that 2017 marked “a sharp increase in what has characterized as the third wave of the opioid epidemic,” said drug and health policy researcher Stephen Crystal, PhD, of Rutgers University, New Brunswick, N.J., in an interview. He was referring to a wave that experts believe started in 2013 amid a spike in U.S. overdose deaths from fentanyl and other synthetic opioids.

The new report analyzes fatal drug overdose data from 2013 to 2017. According to the findings, the total number of those overdoses rose to 70,237 in 2017, up from 63,632 in 2016. The highest drug overdose death rates in 2017 were in West Virginia, followed by Ohio, Pennsylvania, and the District of Columbia.

Some statistics did not change much from 2016 to 2017: About two-thirds of the drug overdose deaths were linked to opioids in both years, and the death rate of cases linked to prescription drugs and heroin remained steady. (Death rates in the report were age adjusted.)

However, the percentage of fatal overdose cases linked to synthetic opioids grew 45% from 2016 to 2017. Overall, 60% of opioid-related fatal overdoses in 2017 involved synthetic opioids.

The report identifies increases in several areas from 2016 to 2017. Opioid-related drug overdose deaths among black people rose by 25%, and an analysis of data from 34 states and the District of Columbia found the highest increases in death rates in North Carolina (29%), Ohio (19%), and Maine (19%).

In regard to deaths linked to synthetic opioids specifically, the highest death rates in 2017 were in West Virginia (37 per 100,000), Ohio (32 per 100,000), and New Hampshire (30 per 100,000).

“Part of what we’re seeing in these increased numbers are individuals who have pain, can’t get prescribed opioids, and turn to street drugs,” Dr. Crystal said, adding that “abruptly cutting patients off is not good, and leaving patients with a lot of untreated pain is not good. If people are going to be discontinued [from opioids] or have their doses reduced, the taper needs to be done very slowly and carefully.”

Synthetic opioids were not the only drugs that are driving up fatal overdoses, as the death rates of cases linked to cocaine and psychostimulants (such as methamphetamine) jumped by more than a third in 2017.

“The most important thing these numbers are telling me is that it’s becoming more and more attractive to drug dealers to put fentanyl in the heroin, cocaine, and other drugs they sell,” Dr. Crystal said. “When that happens, dependence on street drugs becomes much more deadly. It’s almost impossible to get the dose right. Every time you shoot up, you’re taking a chance that you’ll overdose.”

The report had limitations, including the fact that details about drug use were missing from 12% (2016) and 15% (2017) of death certificates in fatal overdose cases. By state, the percentages of those death certificates that included drug information ranged from as little as 55% to 99%.

There’s some possible positive news: The report points to preliminary data from 2018 suggesting that the number of annual drug overdose deaths may be leveling off – although it says more analysis is needed to confirm the trend.

Dr. Crystal, however, is not celebrating. “I don’t see this as a good news story, really,” he said, adding that there’s “a little too much of people patting themselves on the back” because they’re proud of cutbacks in opioid prescriptions.

“This doesn’t have to do with the huge number of people who got started with opioids years ago” and are now at risk of using street drugs, he said. “We haven’t engaged that population at the rate we need to. And flattening out at 70,000 drug overdoses a year is not a good news story.”

Dr. Crystal reported no relevant disclosures.

SOURCE: Scholl L et al. MMWR. 2019 Jan 4;67(5152):1419-27.

New federal statistics suggest that the opioid epidemic in the United States is evolving as physicians crack down on the use of prescription painkillers: Fatal drug overdose deaths rose by 12% from 2016 to 2017, boosted by a wave of fatalities linked to illicit synthetic opioids like fentanyl that are now linked to an estimated 60% of opioid-related deaths.

US DEA

“Overall, the overdose epidemic continues to worsen, and it has grown increasingly complex by coinvolvement of prescription and illicit drugs,” Lawrence Scholl, PhD, MPH, and his associates at the Centers for Disease Control & Prevention wrote in the Morbidity and Mortality Weekly Report.

The new statistics provide more evidence that 2017 marked “a sharp increase in what has characterized as the third wave of the opioid epidemic,” said drug and health policy researcher Stephen Crystal, PhD, of Rutgers University, New Brunswick, N.J., in an interview. He was referring to a wave that experts believe started in 2013 amid a spike in U.S. overdose deaths from fentanyl and other synthetic opioids.

The new report analyzes fatal drug overdose data from 2013 to 2017. According to the findings, the total number of those overdoses rose to 70,237 in 2017, up from 63,632 in 2016. The highest drug overdose death rates in 2017 were in West Virginia, followed by Ohio, Pennsylvania, and the District of Columbia.

Some statistics did not change much from 2016 to 2017: About two-thirds of the drug overdose deaths were linked to opioids in both years, and the death rate of cases linked to prescription drugs and heroin remained steady. (Death rates in the report were age adjusted.)

However, the percentage of fatal overdose cases linked to synthetic opioids grew 45% from 2016 to 2017. Overall, 60% of opioid-related fatal overdoses in 2017 involved synthetic opioids.

The report identifies increases in several areas from 2016 to 2017. Opioid-related drug overdose deaths among black people rose by 25%, and an analysis of data from 34 states and the District of Columbia found the highest increases in death rates in North Carolina (29%), Ohio (19%), and Maine (19%).

In regard to deaths linked to synthetic opioids specifically, the highest death rates in 2017 were in West Virginia (37 per 100,000), Ohio (32 per 100,000), and New Hampshire (30 per 100,000).

“Part of what we’re seeing in these increased numbers are individuals who have pain, can’t get prescribed opioids, and turn to street drugs,” Dr. Crystal said, adding that “abruptly cutting patients off is not good, and leaving patients with a lot of untreated pain is not good. If people are going to be discontinued [from opioids] or have their doses reduced, the taper needs to be done very slowly and carefully.”

Synthetic opioids were not the only drugs that are driving up fatal overdoses, as the death rates of cases linked to cocaine and psychostimulants (such as methamphetamine) jumped by more than a third in 2017.

“The most important thing these numbers are telling me is that it’s becoming more and more attractive to drug dealers to put fentanyl in the heroin, cocaine, and other drugs they sell,” Dr. Crystal said. “When that happens, dependence on street drugs becomes much more deadly. It’s almost impossible to get the dose right. Every time you shoot up, you’re taking a chance that you’ll overdose.”

The report had limitations, including the fact that details about drug use were missing from 12% (2016) and 15% (2017) of death certificates in fatal overdose cases. By state, the percentages of those death certificates that included drug information ranged from as little as 55% to 99%.

There’s some possible positive news: The report points to preliminary data from 2018 suggesting that the number of annual drug overdose deaths may be leveling off – although it says more analysis is needed to confirm the trend.

Dr. Crystal, however, is not celebrating. “I don’t see this as a good news story, really,” he said, adding that there’s “a little too much of people patting themselves on the back” because they’re proud of cutbacks in opioid prescriptions.

“This doesn’t have to do with the huge number of people who got started with opioids years ago” and are now at risk of using street drugs, he said. “We haven’t engaged that population at the rate we need to. And flattening out at 70,000 drug overdoses a year is not a good news story.”

Dr. Crystal reported no relevant disclosures.

SOURCE: Scholl L et al. MMWR. 2019 Jan 4;67(5152):1419-27.

Children exposed to valproate in utero were 48% more likely to be diagnosed with ADHD when compared with unexposed children in a population-based cohort study of more than 900,000 children in Denmark.

Antiepileptic drug exposure is associated with an increased risk of various congenital malformations, but its role in the development of ADHD in children has not been well documented, first author Jakob Christensen, MD, PhD, DrMedSci, of Aarhus (Denmark) University Hospital, and his colleagues wrote in their paper, published online Jan. 4 in JAMA Network Open.

The researchers identified 913,302 singleton births in Denmark from 1997 through 2011, with children followed through 2015.

Overall, children who were prenatally exposed to valproate had a 48% increased risk of ADHD. Antiepileptic drug exposure was defined as 30 days before the estimated day of conception to the day of birth, and included valproate, clobazam, and other antiepileptic drugs. The average age of the children at the study’s end was 10 years, and approximately half were male.

A total of 580 children were exposed to valproate in utero; of these, 8.4% were later diagnosed with ADHD, compared with 3.2% of 912,722 children who were not exposed to valproate. In addition, the absolute 15-year risk of ADHD was 11% in valproate-exposed children vs. 4.6% in unexposed children. No significant associations appeared between ADHD and other antiepileptic drugs.

The study findings were limited by several factors, including the contraindication of valproate for use in pregnancy, which may mean that the women taking valproate had more severe disease, the researchers noted.

“Due to the observational nature of this study, we cannot rule out that the observed risk increase for ADHD is at least in part explained by the mother’s health condition that triggered the prescription of valproate during pregnancy,” they said. Other limitations included a lack of data on the exact amounts of valproate taken during pregnancy and the potential impact of nonepilepsy medications, they noted.

However, the results were strengthened by the large size and population-based cohort, and support warnings by professional medical organizations against valproate use in pregnancy, the researchers said. “As randomized clinical trials of valproate use during pregnancy are neither feasible nor ethical, our study provides clinical information on the risk of ADHD associated with valproate use during pregnancy,” they concluded.

The study was supported by grants to various authors from the Danish Epilepsy Association Central Denmark Region, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the Novo Nordisk Foundation, and the European Commission.

SOURCE: Christensen J et al. JAMA Network Open. 2019;2(1):e186606. doi: 10.1001/jamanetworkopen.2018.6606.

Children exposed to valproate in utero were 48% more likely to be diagnosed with ADHD when compared with unexposed children in a population-based cohort study of more than 900,000 children in Denmark.

Antiepileptic drug exposure is associated with an increased risk of various congenital malformations, but its role in the development of ADHD in children has not been well documented, first author Jakob Christensen, MD, PhD, DrMedSci, of Aarhus (Denmark) University Hospital, and his colleagues wrote in their paper, published online Jan. 4 in JAMA Network Open.

The researchers identified 913,302 singleton births in Denmark from 1997 through 2011, with children followed through 2015.

Overall, children who were prenatally exposed to valproate had a 48% increased risk of ADHD. Antiepileptic drug exposure was defined as 30 days before the estimated day of conception to the day of birth, and included valproate, clobazam, and other antiepileptic drugs. The average age of the children at the study’s end was 10 years, and approximately half were male.

A total of 580 children were exposed to valproate in utero; of these, 8.4% were later diagnosed with ADHD, compared with 3.2% of 912,722 children who were not exposed to valproate. In addition, the absolute 15-year risk of ADHD was 11% in valproate-exposed children vs. 4.6% in unexposed children. No significant associations appeared between ADHD and other antiepileptic drugs.

The study findings were limited by several factors, including the contraindication of valproate for use in pregnancy, which may mean that the women taking valproate had more severe disease, the researchers noted.

“Due to the observational nature of this study, we cannot rule out that the observed risk increase for ADHD is at least in part explained by the mother’s health condition that triggered the prescription of valproate during pregnancy,” they said. Other limitations included a lack of data on the exact amounts of valproate taken during pregnancy and the potential impact of nonepilepsy medications, they noted.

However, the results were strengthened by the large size and population-based cohort, and support warnings by professional medical organizations against valproate use in pregnancy, the researchers said. “As randomized clinical trials of valproate use during pregnancy are neither feasible nor ethical, our study provides clinical information on the risk of ADHD associated with valproate use during pregnancy,” they concluded.

The study was supported by grants to various authors from the Danish Epilepsy Association Central Denmark Region, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the Novo Nordisk Foundation, and the European Commission.

SOURCE: Christensen J et al. JAMA Network Open. 2019;2(1):e186606. doi: 10.1001/jamanetworkopen.2018.6606.

Children exposed to valproate in utero were 48% more likely to be diagnosed with ADHD when compared with unexposed children in a population-based cohort study of more than 900,000 children in Denmark.

Antiepileptic drug exposure is associated with an increased risk of various congenital malformations, but its role in the development of ADHD in children has not been well documented, first author Jakob Christensen, MD, PhD, DrMedSci, of Aarhus (Denmark) University Hospital, and his colleagues wrote in their paper, published online Jan. 4 in JAMA Network Open.

The researchers identified 913,302 singleton births in Denmark from 1997 through 2011, with children followed through 2015.

Overall, children who were prenatally exposed to valproate had a 48% increased risk of ADHD. Antiepileptic drug exposure was defined as 30 days before the estimated day of conception to the day of birth, and included valproate, clobazam, and other antiepileptic drugs. The average age of the children at the study’s end was 10 years, and approximately half were male.

A total of 580 children were exposed to valproate in utero; of these, 8.4% were later diagnosed with ADHD, compared with 3.2% of 912,722 children who were not exposed to valproate. In addition, the absolute 15-year risk of ADHD was 11% in valproate-exposed children vs. 4.6% in unexposed children. No significant associations appeared between ADHD and other antiepileptic drugs.

The study findings were limited by several factors, including the contraindication of valproate for use in pregnancy, which may mean that the women taking valproate had more severe disease, the researchers noted.

“Due to the observational nature of this study, we cannot rule out that the observed risk increase for ADHD is at least in part explained by the mother’s health condition that triggered the prescription of valproate during pregnancy,” they said. Other limitations included a lack of data on the exact amounts of valproate taken during pregnancy and the potential impact of nonepilepsy medications, they noted.

However, the results were strengthened by the large size and population-based cohort, and support warnings by professional medical organizations against valproate use in pregnancy, the researchers said. “As randomized clinical trials of valproate use during pregnancy are neither feasible nor ethical, our study provides clinical information on the risk of ADHD associated with valproate use during pregnancy,” they concluded.

The study was supported by grants to various authors from the Danish Epilepsy Association Central Denmark Region, the Aarhus University Research Foundation, the Lundbeck Foundation, the National Institutes of Health, the Novo Nordisk Foundation, and the European Commission.

SOURCE: Christensen J et al. JAMA Network Open. 2019;2(1):e186606. doi: 10.1001/jamanetworkopen.2018.6606.

Patients with hypertension who show substantial progression of cerebral small vessel disease over time have sixfold higher odds of developing mild cognitive impairment than do those without signs of progression on brain MRI, new research has found.

American Heart Association

The results, published online Jan. 4 in Hypertension, come from a longitudinal, population-based study of 976 patients with hypertension but with no history of dementia or clinical stroke. Participants underwent a vascular risk assessment, brain MRI, cognitive evaluation, and blood sampling at baseline, and 345 patients were also retested after a mean of nearly 4 years.

Researchers saw significant sixfold higher odds of developing incident mild cognitive impairment (MCI) among individuals who showed marked progression of periventricular white matter hyperintensities – an imaging hallmark of cerebral small vessel disease – compared with individuals who did not show any progression (odds ratio = 6.184; 95% confidence interval, 1.506-25.370; P = .011).

Patients with greater progression of periventricular white matter hyperintensities also showed significantly greater decreases in global cognition scores – both in total DRS-2 Z-score and executive function Z-score – when compared against individuals without white matter hyperintensity progression.

“As MCI is one of the most important risk factors in the development of dementia, future research should investigate the mechanisms by which PVH [periventricular white matter hyperintensities] trigger cognitive impairment and the clinical utility of its assessment,” wrote Joan Jiménez-Balado of Vall d’Hebron Research Institute, Barcelona, and his associates.

However, deep white matter hyperintensity progression – as opposed to periventricular – was not linked to cognitive changes, except in the case of bilateral occipital deep white matter hyperintensity changes, which were linked to a significant worsening in the attention Z-score.

The authors noted that the different impacts of periventricular versus deep white matter hyperintensities may relate to a number of factors. The first was that deep white matter hyperintensities disrupt cortico-cortical connections but periventricular ones are more likely to affect long cortico-subcortical association fibers, which “would be an important variable to determine the impaired networks involved in cognition.”

They also suggested that periventricular and deep white matter hyperintensities may affect different neuromodulator systems; the periventricular white matter could be closer to ascending cholinergic bundles that may play a role in vascular cognitive impairment.

Periventricular white matter hyperintensities may also accelerate the deposition of amyloid because of their association with venous collagenosis, which is linked to ischemia and disruptions of the interstitial fluid circulation.

“On the other hand, [deep white matter hyperintensity] may be more related to hypoperfusion, as deep areas are particularly vulnerable to low [blood pressure],” the authors wrote, while stressing that the pathophysiology of white matter hyperintensities is not fully understood, so further research is needed.

Overall, the 345 patients with follow-up data had a median age of 65 years at baseline and mean blood pressure of 143/78.2 mm Hg at baseline and 146.5/75 mm Hg at follow-up. White matter hyperintensity changes occurred periventricularly in 22% and in deep white matter in 48%. The researchers saw new infarcts in 6.1% of patients, and 5.5% had incident cerebral microbleeds. While incident cerebral microbleeds were significantly associated with declines in the attention Z-score, they did not affect other cognitive functions, and incidental infarcts were also not associated with cognitive changes.

Baseline blood pressure and average blood pressure during follow-up were not associated with changes in cardiac small vessel disease lesions. However, diastolic – but not systolic – blood pressure at baseline and follow-up was positively correlated with total, attention, and executive function DRS-2 Z-scores at follow-up.

Three-quarters of patients showed cognitive changes associated with normal aging both at baseline and follow-up, 9.1% had stable MCI, and 9.1% of patients had incident MCI. However, 6.6% of subjects reverted back to normal aging after having MCI at baseline.

The authors noted that they did not examine markers of neurodegeneration, such as tau or amyloid-beta, which could also be linked to hypertension and cerebral small vessel disease lesions.

The study was supported by Instituto de Salud Carlos III, AGAUR (Agency for Management of University and Research Grants), the Secretary of Universities and Research of the Department of Economy and Knowledge, and the European Regional Development Fund. The authors said they have no conflicts of interest.

SOURCE: Jiménez-Balado J et al. Hypertension. 2019 Jan 4. doi: 10.1161/HYPERTENSIONAHA.118.12090

Patients with hypertension who show substantial progression of cerebral small vessel disease over time have sixfold higher odds of developing mild cognitive impairment than do those without signs of progression on brain MRI, new research has found.

American Heart Association

The results, published online Jan. 4 in Hypertension, come from a longitudinal, population-based study of 976 patients with hypertension but with no history of dementia or clinical stroke. Participants underwent a vascular risk assessment, brain MRI, cognitive evaluation, and blood sampling at baseline, and 345 patients were also retested after a mean of nearly 4 years.

Researchers saw significant sixfold higher odds of developing incident mild cognitive impairment (MCI) among individuals who showed marked progression of periventricular white matter hyperintensities – an imaging hallmark of cerebral small vessel disease – compared with individuals who did not show any progression (odds ratio = 6.184; 95% confidence interval, 1.506-25.370; P = .011).

Patients with greater progression of periventricular white matter hyperintensities also showed significantly greater decreases in global cognition scores – both in total DRS-2 Z-score and executive function Z-score – when compared against individuals without white matter hyperintensity progression.

“As MCI is one of the most important risk factors in the development of dementia, future research should investigate the mechanisms by which PVH [periventricular white matter hyperintensities] trigger cognitive impairment and the clinical utility of its assessment,” wrote Joan Jiménez-Balado of Vall d’Hebron Research Institute, Barcelona, and his associates.

However, deep white matter hyperintensity progression – as opposed to periventricular – was not linked to cognitive changes, except in the case of bilateral occipital deep white matter hyperintensity changes, which were linked to a significant worsening in the attention Z-score.

The authors noted that the different impacts of periventricular versus deep white matter hyperintensities may relate to a number of factors. The first was that deep white matter hyperintensities disrupt cortico-cortical connections but periventricular ones are more likely to affect long cortico-subcortical association fibers, which “would be an important variable to determine the impaired networks involved in cognition.”

They also suggested that periventricular and deep white matter hyperintensities may affect different neuromodulator systems; the periventricular white matter could be closer to ascending cholinergic bundles that may play a role in vascular cognitive impairment.

Periventricular white matter hyperintensities may also accelerate the deposition of amyloid because of their association with venous collagenosis, which is linked to ischemia and disruptions of the interstitial fluid circulation.

“On the other hand, [deep white matter hyperintensity] may be more related to hypoperfusion, as deep areas are particularly vulnerable to low [blood pressure],” the authors wrote, while stressing that the pathophysiology of white matter hyperintensities is not fully understood, so further research is needed.

Overall, the 345 patients with follow-up data had a median age of 65 years at baseline and mean blood pressure of 143/78.2 mm Hg at baseline and 146.5/75 mm Hg at follow-up. White matter hyperintensity changes occurred periventricularly in 22% and in deep white matter in 48%. The researchers saw new infarcts in 6.1% of patients, and 5.5% had incident cerebral microbleeds. While incident cerebral microbleeds were significantly associated with declines in the attention Z-score, they did not affect other cognitive functions, and incidental infarcts were also not associated with cognitive changes.

Baseline blood pressure and average blood pressure during follow-up were not associated with changes in cardiac small vessel disease lesions. However, diastolic – but not systolic – blood pressure at baseline and follow-up was positively correlated with total, attention, and executive function DRS-2 Z-scores at follow-up.

Three-quarters of patients showed cognitive changes associated with normal aging both at baseline and follow-up, 9.1% had stable MCI, and 9.1% of patients had incident MCI. However, 6.6% of subjects reverted back to normal aging after having MCI at baseline.

The authors noted that they did not examine markers of neurodegeneration, such as tau or amyloid-beta, which could also be linked to hypertension and cerebral small vessel disease lesions.

The study was supported by Instituto de Salud Carlos III, AGAUR (Agency for Management of University and Research Grants), the Secretary of Universities and Research of the Department of Economy and Knowledge, and the European Regional Development Fund. The authors said they have no conflicts of interest.

SOURCE: Jiménez-Balado J et al. Hypertension. 2019 Jan 4. doi: 10.1161/HYPERTENSIONAHA.118.12090

Patients with hypertension who show substantial progression of cerebral small vessel disease over time have sixfold higher odds of developing mild cognitive impairment than do those without signs of progression on brain MRI, new research has found.

American Heart Association

The results, published online Jan. 4 in Hypertension, come from a longitudinal, population-based study of 976 patients with hypertension but with no history of dementia or clinical stroke. Participants underwent a vascular risk assessment, brain MRI, cognitive evaluation, and blood sampling at baseline, and 345 patients were also retested after a mean of nearly 4 years.

Researchers saw significant sixfold higher odds of developing incident mild cognitive impairment (MCI) among individuals who showed marked progression of periventricular white matter hyperintensities – an imaging hallmark of cerebral small vessel disease – compared with individuals who did not show any progression (odds ratio = 6.184; 95% confidence interval, 1.506-25.370; P = .011).

Patients with greater progression of periventricular white matter hyperintensities also showed significantly greater decreases in global cognition scores – both in total DRS-2 Z-score and executive function Z-score – when compared against individuals without white matter hyperintensity progression.

“As MCI is one of the most important risk factors in the development of dementia, future research should investigate the mechanisms by which PVH [periventricular white matter hyperintensities] trigger cognitive impairment and the clinical utility of its assessment,” wrote Joan Jiménez-Balado of Vall d’Hebron Research Institute, Barcelona, and his associates.

However, deep white matter hyperintensity progression – as opposed to periventricular – was not linked to cognitive changes, except in the case of bilateral occipital deep white matter hyperintensity changes, which were linked to a significant worsening in the attention Z-score.

The authors noted that the different impacts of periventricular versus deep white matter hyperintensities may relate to a number of factors. The first was that deep white matter hyperintensities disrupt cortico-cortical connections but periventricular ones are more likely to affect long cortico-subcortical association fibers, which “would be an important variable to determine the impaired networks involved in cognition.”

They also suggested that periventricular and deep white matter hyperintensities may affect different neuromodulator systems; the periventricular white matter could be closer to ascending cholinergic bundles that may play a role in vascular cognitive impairment.

Periventricular white matter hyperintensities may also accelerate the deposition of amyloid because of their association with venous collagenosis, which is linked to ischemia and disruptions of the interstitial fluid circulation.

“On the other hand, [deep white matter hyperintensity] may be more related to hypoperfusion, as deep areas are particularly vulnerable to low [blood pressure],” the authors wrote, while stressing that the pathophysiology of white matter hyperintensities is not fully understood, so further research is needed.

Overall, the 345 patients with follow-up data had a median age of 65 years at baseline and mean blood pressure of 143/78.2 mm Hg at baseline and 146.5/75 mm Hg at follow-up. White matter hyperintensity changes occurred periventricularly in 22% and in deep white matter in 48%. The researchers saw new infarcts in 6.1% of patients, and 5.5% had incident cerebral microbleeds. While incident cerebral microbleeds were significantly associated with declines in the attention Z-score, they did not affect other cognitive functions, and incidental infarcts were also not associated with cognitive changes.

Baseline blood pressure and average blood pressure during follow-up were not associated with changes in cardiac small vessel disease lesions. However, diastolic – but not systolic – blood pressure at baseline and follow-up was positively correlated with total, attention, and executive function DRS-2 Z-scores at follow-up.

Three-quarters of patients showed cognitive changes associated with normal aging both at baseline and follow-up, 9.1% had stable MCI, and 9.1% of patients had incident MCI. However, 6.6% of subjects reverted back to normal aging after having MCI at baseline.

The authors noted that they did not examine markers of neurodegeneration, such as tau or amyloid-beta, which could also be linked to hypertension and cerebral small vessel disease lesions.

The study was supported by Instituto de Salud Carlos III, AGAUR (Agency for Management of University and Research Grants), the Secretary of Universities and Research of the Department of Economy and Knowledge, and the European Regional Development Fund. The authors said they have no conflicts of interest.

SOURCE: Jiménez-Balado J et al. Hypertension. 2019 Jan 4. doi: 10.1161/HYPERTENSIONAHA.118.12090

Taking aspirin and omega-3 polyunsaturated fatty acid did not reduce the colorectal adenoma among high-risk patients. Also today, New data reveal that college students are at greater risk of meningococcal B infection, children who survive Hodgkin lymphoma face a massive increased risk for second cancers down the road, and the 2018/19 flu season shows high activity in nine states.

Amazon Alexa

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Spotify
 

Taking aspirin and omega-3 polyunsaturated fatty acid did not reduce the colorectal adenoma among high-risk patients. Also today, New data reveal that college students are at greater risk of meningococcal B infection, children who survive Hodgkin lymphoma face a massive increased risk for second cancers down the road, and the 2018/19 flu season shows high activity in nine states.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Taking aspirin and omega-3 polyunsaturated fatty acid did not reduce the colorectal adenoma among high-risk patients. Also today, New data reveal that college students are at greater risk of meningococcal B infection, children who survive Hodgkin lymphoma face a massive increased risk for second cancers down the road, and the 2018/19 flu season shows high activity in nine states.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

Raymond Barfield, MD, nearly left medicine altogether after experiencing burnout. Now, he joins the Postcall Podcast to discuss why he’s back, what he’s working on to prevent burnout, and how he wants to remake pre-med education. You can read more from Dr. Barfield’s story here.

Apple Podcasts

Google Podcasts

Spotify
 

Data security experts say three HIPAA violations that resulted in significant fines by the Office for Civil Rights (OCR) in 2018 hold important lessons for health professionals about safeguarding records and training staff in HIPAA compliance.

Read on to learn how the cases unfolded and what knowledge practices can gain from the common HIPAA mistakes.

Who? Allergy Associates of Hartford, Conn.

What happened? A patient contacted a local television station to complain about a dispute between herself and a physician at Allergy Associates in Hartford, Conn. The disagreement stemmed from the office turning away the patient because she allegedly brought her service animal, according to a Nov. 26 announcement by the Department of Health & Human Services. The reporter contacted the doctor in question for a news story and, in responding, the physician disclosed protected patient information to the reporter.

razihusin/iStock/Getty Images Plus

Lessons learned: Had the practice disciplined the physician or taken corrective action after the disclosure, the OCR may not have penalized the group so severely, according to Jennifer Mitchell, a Cincinnati-based health law attorney and vice chair of the American Bar Association eHealth, Privacy, & Security Interest Group.

“In my opinion, the government levied these penalties because the provider did not sanction the doctor,” Ms. Mitchell said in an interview. “Health care entities need to take proper steps to remediate and, at a minimum, hold their workforce responsible for their behavior and ensure that it won’t happen again.”

The case emphasizes the need to train team members on media protocols and to ensure that protected health information is not mistakenly released. In addition to implementing policies and procedures, practices must also be willing to discipline health professionals when violations occur.

“A health care provider’s natural inclination is to defend themselves if they are being accused by a patient,” she said. “However, under the HIPAA rules, health care providers have to understand that they are prohibited from making such public statements about any patient.”

Who? Advanced Care Hospitalists of Lakeland, Fla.
 

What happened? Advanced Care Hospitalists (ACH) received billing services from an individual who represented himself to be affiliated with a Florida-based company named Doctor’s First Choice Billing. A local hospital later notified ACH that patient information, including names and Social Security numbers, were viewable on the First Choice website. ACH identified at least 400 patients affected by the breach and reported the breach to the OCR. However, ACH later determined that an additional 8,855 patients may have been affected and revised its OCR notification.

Kameleon007/iStock/Getty Images Plus

Under HIPAA, a business associate is defined as a person or entity, other than a member of the workforce of a covered entity, who “performs functions or activities on behalf of, or provides certain services to, a covered entity that involve access by the business associate to protected health information.”

HIPAA requires that covered entities enter into contracts with business associates to ensure appropriate safeguarding of protected health information.

“If your business associate has a breach, your practice must report the breach to OCR and your patients,” Mr. Mikel said in an interview. “The OCR will then investigate your practice and your relationship with the business associate. Just because the breach and fault clearly happened elsewhere, you will still be investigated, and could face a penalty if HIPAA requirements weren’t met.”

Who? Filefax of Northbrook, Ill.
 

What happened? The OCR opened an investigation after receiving an anonymous complaint that medical records obtained from Filefax, a company that provided storage, maintenance, and delivery of medical records for health professionals, were left unmonitored at a shredding and recycling facility. OCR’s investigation revealed that a person left the records of 2,150 patients at the recycling plant and that the records contained protected health information, according to an HHS announcement. It is unclear if the person worked for Filefax.

MarkLevant/iStock/Getty Images Plus

“[Such a case is] ripe for a patient to complain to OCR,” he said. “OCR doesn’t care if you’re closed or retired, they’re going to look.”

HIPAA requires thatcovered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information in any form when moving or closing. The safeguards must prevent prohibited uses and disclosures of protected health information in connection with the disposal of such information, according to the rule. The HHS provides guidance for the disposing of medical records; further, the American Academy of Family Physicians has created a checklist on closing a practice that addresses the transferring of medical records.

Without taking the correct measures, doctors may end up drawing scrutiny from OCR and face a potential fine if violations are found, experts said.

“Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them,” Mr. Severino of the OCR said in a statement. “HIPAA still applies.”

Data security experts say three HIPAA violations that resulted in significant fines by the Office for Civil Rights (OCR) in 2018 hold important lessons for health professionals about safeguarding records and training staff in HIPAA compliance.

Read on to learn how the cases unfolded and what knowledge practices can gain from the common HIPAA mistakes.

Who? Allergy Associates of Hartford, Conn.

What happened? A patient contacted a local television station to complain about a dispute between herself and a physician at Allergy Associates in Hartford, Conn. The disagreement stemmed from the office turning away the patient because she allegedly brought her service animal, according to a Nov. 26 announcement by the Department of Health & Human Services. The reporter contacted the doctor in question for a news story and, in responding, the physician disclosed protected patient information to the reporter.

razihusin/iStock/Getty Images Plus

Lessons learned: Had the practice disciplined the physician or taken corrective action after the disclosure, the OCR may not have penalized the group so severely, according to Jennifer Mitchell, a Cincinnati-based health law attorney and vice chair of the American Bar Association eHealth, Privacy, & Security Interest Group.

“In my opinion, the government levied these penalties because the provider did not sanction the doctor,” Ms. Mitchell said in an interview. “Health care entities need to take proper steps to remediate and, at a minimum, hold their workforce responsible for their behavior and ensure that it won’t happen again.”

The case emphasizes the need to train team members on media protocols and to ensure that protected health information is not mistakenly released. In addition to implementing policies and procedures, practices must also be willing to discipline health professionals when violations occur.

“A health care provider’s natural inclination is to defend themselves if they are being accused by a patient,” she said. “However, under the HIPAA rules, health care providers have to understand that they are prohibited from making such public statements about any patient.”

Who? Advanced Care Hospitalists of Lakeland, Fla.
 

What happened? Advanced Care Hospitalists (ACH) received billing services from an individual who represented himself to be affiliated with a Florida-based company named Doctor’s First Choice Billing. A local hospital later notified ACH that patient information, including names and Social Security numbers, were viewable on the First Choice website. ACH identified at least 400 patients affected by the breach and reported the breach to the OCR. However, ACH later determined that an additional 8,855 patients may have been affected and revised its OCR notification.

Kameleon007/iStock/Getty Images Plus

Under HIPAA, a business associate is defined as a person or entity, other than a member of the workforce of a covered entity, who “performs functions or activities on behalf of, or provides certain services to, a covered entity that involve access by the business associate to protected health information.”

HIPAA requires that covered entities enter into contracts with business associates to ensure appropriate safeguarding of protected health information.

“If your business associate has a breach, your practice must report the breach to OCR and your patients,” Mr. Mikel said in an interview. “The OCR will then investigate your practice and your relationship with the business associate. Just because the breach and fault clearly happened elsewhere, you will still be investigated, and could face a penalty if HIPAA requirements weren’t met.”

Who? Filefax of Northbrook, Ill.
 

What happened? The OCR opened an investigation after receiving an anonymous complaint that medical records obtained from Filefax, a company that provided storage, maintenance, and delivery of medical records for health professionals, were left unmonitored at a shredding and recycling facility. OCR’s investigation revealed that a person left the records of 2,150 patients at the recycling plant and that the records contained protected health information, according to an HHS announcement. It is unclear if the person worked for Filefax.

MarkLevant/iStock/Getty Images Plus

“[Such a case is] ripe for a patient to complain to OCR,” he said. “OCR doesn’t care if you’re closed or retired, they’re going to look.”

HIPAA requires thatcovered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information in any form when moving or closing. The safeguards must prevent prohibited uses and disclosures of protected health information in connection with the disposal of such information, according to the rule. The HHS provides guidance for the disposing of medical records; further, the American Academy of Family Physicians has created a checklist on closing a practice that addresses the transferring of medical records.

Without taking the correct measures, doctors may end up drawing scrutiny from OCR and face a potential fine if violations are found, experts said.

“Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them,” Mr. Severino of the OCR said in a statement. “HIPAA still applies.”

Data security experts say three HIPAA violations that resulted in significant fines by the Office for Civil Rights (OCR) in 2018 hold important lessons for health professionals about safeguarding records and training staff in HIPAA compliance.

Read on to learn how the cases unfolded and what knowledge practices can gain from the common HIPAA mistakes.

Who? Allergy Associates of Hartford, Conn.

What happened? A patient contacted a local television station to complain about a dispute between herself and a physician at Allergy Associates in Hartford, Conn. The disagreement stemmed from the office turning away the patient because she allegedly brought her service animal, according to a Nov. 26 announcement by the Department of Health & Human Services. The reporter contacted the doctor in question for a news story and, in responding, the physician disclosed protected patient information to the reporter.

razihusin/iStock/Getty Images Plus

Lessons learned: Had the practice disciplined the physician or taken corrective action after the disclosure, the OCR may not have penalized the group so severely, according to Jennifer Mitchell, a Cincinnati-based health law attorney and vice chair of the American Bar Association eHealth, Privacy, & Security Interest Group.

“In my opinion, the government levied these penalties because the provider did not sanction the doctor,” Ms. Mitchell said in an interview. “Health care entities need to take proper steps to remediate and, at a minimum, hold their workforce responsible for their behavior and ensure that it won’t happen again.”

The case emphasizes the need to train team members on media protocols and to ensure that protected health information is not mistakenly released. In addition to implementing policies and procedures, practices must also be willing to discipline health professionals when violations occur.

“A health care provider’s natural inclination is to defend themselves if they are being accused by a patient,” she said. “However, under the HIPAA rules, health care providers have to understand that they are prohibited from making such public statements about any patient.”

Who? Advanced Care Hospitalists of Lakeland, Fla.
 

What happened? Advanced Care Hospitalists (ACH) received billing services from an individual who represented himself to be affiliated with a Florida-based company named Doctor’s First Choice Billing. A local hospital later notified ACH that patient information, including names and Social Security numbers, were viewable on the First Choice website. ACH identified at least 400 patients affected by the breach and reported the breach to the OCR. However, ACH later determined that an additional 8,855 patients may have been affected and revised its OCR notification.

Kameleon007/iStock/Getty Images Plus

Under HIPAA, a business associate is defined as a person or entity, other than a member of the workforce of a covered entity, who “performs functions or activities on behalf of, or provides certain services to, a covered entity that involve access by the business associate to protected health information.”

HIPAA requires that covered entities enter into contracts with business associates to ensure appropriate safeguarding of protected health information.

“If your business associate has a breach, your practice must report the breach to OCR and your patients,” Mr. Mikel said in an interview. “The OCR will then investigate your practice and your relationship with the business associate. Just because the breach and fault clearly happened elsewhere, you will still be investigated, and could face a penalty if HIPAA requirements weren’t met.”

Who? Filefax of Northbrook, Ill.
 

What happened? The OCR opened an investigation after receiving an anonymous complaint that medical records obtained from Filefax, a company that provided storage, maintenance, and delivery of medical records for health professionals, were left unmonitored at a shredding and recycling facility. OCR’s investigation revealed that a person left the records of 2,150 patients at the recycling plant and that the records contained protected health information, according to an HHS announcement. It is unclear if the person worked for Filefax.

MarkLevant/iStock/Getty Images Plus

“[Such a case is] ripe for a patient to complain to OCR,” he said. “OCR doesn’t care if you’re closed or retired, they’re going to look.”

HIPAA requires thatcovered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information in any form when moving or closing. The safeguards must prevent prohibited uses and disclosures of protected health information in connection with the disposal of such information, according to the rule. The HHS provides guidance for the disposing of medical records; further, the American Academy of Family Physicians has created a checklist on closing a practice that addresses the transferring of medical records.

Without taking the correct measures, doctors may end up drawing scrutiny from OCR and face a potential fine if violations are found, experts said.

“Covered entities and business associates need to be aware that OCR is committed to enforcing HIPAA regardless of whether a covered entity is opening its doors or closing them,” Mr. Severino of the OCR said in a statement. “HIPAA still applies.”

I’ll put up with a lot in this practice, but I will not tolerate mistreatment of my staff.

ALLVISIONN/Thinkstock

Rudeness, while never pleasant, is generally tolerated. Some people just have that sort of personality. Others may be having a crappy day for unrelated reasons. We all have those.

But those who are intentionally abusive of my hardworking assistants aren’t going to get very far here. I have no problem telling them to go elsewhere. (This doesn’t include those with neurologic reasons for such behavior.)

Some doctors are more willing to put up with this than I am. I once shared space with one who routinely told his staff to ignore abusive behaviors. He didn’t want to turn away any potential revenue or risk angering a referring doctor.

I take another view. Life is short, and medical practice is, by nature, hectic. I have little enough time to care for the patients who genuinely appreciate what my staff and I are trying to do for them. People who are abusive and belligerent can find another doctor who’s willing to put up with it. I won’t.

My staff and I don’t expect to be thanked. We all signed up to work here. But we also try to treat patients with concern and respect, and ask the same courtesy in return. Isn’t that the golden rule?

Abusive patients are difficult to deal with, time consuming, and contribute to staff burnout. The two awesome women who work here deserve better than that. If they’re not happy, I’m not happy. All it takes is one bad person to throw the day off kilter and sometimes affect the care of the next patient in line. That person deserves better, too.

Some will argue that, as a doctor, I should care for all who need my help. In the hospital, I do. I understand that people there generally are scared and hurting and do not want to be there. But in my office I expect at least some degree of civility. We have to be at our best for each person who comes in, and having patients we can work with on a polite level helps.

There’s enough insanity in this job on a good day. People who intentionally try to make it worse aren’t welcome in my little world.

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

I’ll put up with a lot in this practice, but I will not tolerate mistreatment of my staff.

ALLVISIONN/Thinkstock

Rudeness, while never pleasant, is generally tolerated. Some people just have that sort of personality. Others may be having a crappy day for unrelated reasons. We all have those.

But those who are intentionally abusive of my hardworking assistants aren’t going to get very far here. I have no problem telling them to go elsewhere. (This doesn’t include those with neurologic reasons for such behavior.)

Some doctors are more willing to put up with this than I am. I once shared space with one who routinely told his staff to ignore abusive behaviors. He didn’t want to turn away any potential revenue or risk angering a referring doctor.

I take another view. Life is short, and medical practice is, by nature, hectic. I have little enough time to care for the patients who genuinely appreciate what my staff and I are trying to do for them. People who are abusive and belligerent can find another doctor who’s willing to put up with it. I won’t.

My staff and I don’t expect to be thanked. We all signed up to work here. But we also try to treat patients with concern and respect, and ask the same courtesy in return. Isn’t that the golden rule?

Abusive patients are difficult to deal with, time consuming, and contribute to staff burnout. The two awesome women who work here deserve better than that. If they’re not happy, I’m not happy. All it takes is one bad person to throw the day off kilter and sometimes affect the care of the next patient in line. That person deserves better, too.

Some will argue that, as a doctor, I should care for all who need my help. In the hospital, I do. I understand that people there generally are scared and hurting and do not want to be there. But in my office I expect at least some degree of civility. We have to be at our best for each person who comes in, and having patients we can work with on a polite level helps.

There’s enough insanity in this job on a good day. People who intentionally try to make it worse aren’t welcome in my little world.

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

I’ll put up with a lot in this practice, but I will not tolerate mistreatment of my staff.

ALLVISIONN/Thinkstock

Rudeness, while never pleasant, is generally tolerated. Some people just have that sort of personality. Others may be having a crappy day for unrelated reasons. We all have those.

But those who are intentionally abusive of my hardworking assistants aren’t going to get very far here. I have no problem telling them to go elsewhere. (This doesn’t include those with neurologic reasons for such behavior.)

Some doctors are more willing to put up with this than I am. I once shared space with one who routinely told his staff to ignore abusive behaviors. He didn’t want to turn away any potential revenue or risk angering a referring doctor.

I take another view. Life is short, and medical practice is, by nature, hectic. I have little enough time to care for the patients who genuinely appreciate what my staff and I are trying to do for them. People who are abusive and belligerent can find another doctor who’s willing to put up with it. I won’t.

My staff and I don’t expect to be thanked. We all signed up to work here. But we also try to treat patients with concern and respect, and ask the same courtesy in return. Isn’t that the golden rule?

Abusive patients are difficult to deal with, time consuming, and contribute to staff burnout. The two awesome women who work here deserve better than that. If they’re not happy, I’m not happy. All it takes is one bad person to throw the day off kilter and sometimes affect the care of the next patient in line. That person deserves better, too.

Some will argue that, as a doctor, I should care for all who need my help. In the hospital, I do. I understand that people there generally are scared and hurting and do not want to be there. But in my office I expect at least some degree of civility. We have to be at our best for each person who comes in, and having patients we can work with on a polite level helps.

There’s enough insanity in this job on a good day. People who intentionally try to make it worse aren’t welcome in my little world.

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

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify
 

Electronic health records predict physician burnout. Also today, a new risk-prediction model for diabetes under development, firibastat is looking good for difficult-to-treat hypertension, and differences in gut bacteria can distinguish IBD from IBS.

Amazon Alexa
Apple Podcasts
Google Podcasts
Spotify