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Combo antifungal/corticosteroid creams contraindicated in children
Don’t use combination antifungal/corticosteroid medications in children or for treating diaper dermatitis, warned Chikoti M. Wheat, MD, of Johns Hopkins University, Baltimore, and her associates.
Lotrisone is a combination product with a high-potency topical corticosteroid, betamethasone dipropionate 0.05% cream, and a topical antifungal agent, clotrimazole 1% cream. The Food and Drug Administration does not recommend it for the population and indication mentioned above, yet it is often used so off-label, Dr. Wheat and her associates said. Mycolog-II, a combination antifungal/corticosteroid with nystatin, an antiyeast agent, and triamcinolone, a medium-potency topical steroid, was taken off the market in 2015, but patients may still have some that they are inclined to use (J Pediatr. 2017. doi: 0.1016/j.jpeds.2017.03.031).
In a study of 9,797 patients aged 0-14 years who were prescribed either Lotrisone or Mycolog-II creams from 2007 to 2014, pediatricians were most likely to prescribe the combination creams (mean, 810 patients), followed by family physicians (mean, 309 patients), and dermatologists (mean, 49 patients). No pediatric dermatologists prescribed either cream.
Why are these combination creams being used?
Sometimes a fungal infection induces an inflammatory dermatitis. In these cases the use of both an antifungal and a corticosteroid with careful monitoring can benefit the patient, the researchers said. “Research, however, has shown that when combination antifungal/corticosteroid agents are used for fungal infections, they not only result in high rates of recurrence of fungal infections but also have greater side effect profiles.”
Also, in 1984, Lotrisone was approved by the FDA for treating tinea corporis, tinea pedis, and tinea cruris in patients older than 12 years. However, lack of efficacy and severe adverse effects including hypothalamic-pituitary-adrenal axis suppression, Cushing syndrome, hyperglycemia, hirsutism, delayed growth, and skin atrophy led the FDA to recommend that Lotrisone not be prescribed for patients younger than 17 years and not be prescribed to treat diaper dermatitis.
So what should you do?
Dr. Wheat and her associates recommend a single-agent topical antifungal to treat superficial fungal infection. If there is intense itching due to infection-induced dermatitis, add a low- or medium-potency topical corticosteroid for just 7-10 days.
For diaper dermatitis with a confirmed secondary fungal infection, they recommend a topical antifungal agent in combination with a barrier cream. “If intense inflammatory changes are present, a low- to medium-potency topical corticosteroid can be used up to twice daily and tapered over 1-2 weeks with careful monitoring,” they said.
Dr. Wheat and her associates declared they had no conflicts of interest.
cnellist@frontlinemedcom.com
Don’t use combination antifungal/corticosteroid medications in children or for treating diaper dermatitis, warned Chikoti M. Wheat, MD, of Johns Hopkins University, Baltimore, and her associates.
Lotrisone is a combination product with a high-potency topical corticosteroid, betamethasone dipropionate 0.05% cream, and a topical antifungal agent, clotrimazole 1% cream. The Food and Drug Administration does not recommend it for the population and indication mentioned above, yet it is often used so off-label, Dr. Wheat and her associates said. Mycolog-II, a combination antifungal/corticosteroid with nystatin, an antiyeast agent, and triamcinolone, a medium-potency topical steroid, was taken off the market in 2015, but patients may still have some that they are inclined to use (J Pediatr. 2017. doi: 0.1016/j.jpeds.2017.03.031).
In a study of 9,797 patients aged 0-14 years who were prescribed either Lotrisone or Mycolog-II creams from 2007 to 2014, pediatricians were most likely to prescribe the combination creams (mean, 810 patients), followed by family physicians (mean, 309 patients), and dermatologists (mean, 49 patients). No pediatric dermatologists prescribed either cream.
Why are these combination creams being used?
Sometimes a fungal infection induces an inflammatory dermatitis. In these cases the use of both an antifungal and a corticosteroid with careful monitoring can benefit the patient, the researchers said. “Research, however, has shown that when combination antifungal/corticosteroid agents are used for fungal infections, they not only result in high rates of recurrence of fungal infections but also have greater side effect profiles.”
Also, in 1984, Lotrisone was approved by the FDA for treating tinea corporis, tinea pedis, and tinea cruris in patients older than 12 years. However, lack of efficacy and severe adverse effects including hypothalamic-pituitary-adrenal axis suppression, Cushing syndrome, hyperglycemia, hirsutism, delayed growth, and skin atrophy led the FDA to recommend that Lotrisone not be prescribed for patients younger than 17 years and not be prescribed to treat diaper dermatitis.
So what should you do?
Dr. Wheat and her associates recommend a single-agent topical antifungal to treat superficial fungal infection. If there is intense itching due to infection-induced dermatitis, add a low- or medium-potency topical corticosteroid for just 7-10 days.
For diaper dermatitis with a confirmed secondary fungal infection, they recommend a topical antifungal agent in combination with a barrier cream. “If intense inflammatory changes are present, a low- to medium-potency topical corticosteroid can be used up to twice daily and tapered over 1-2 weeks with careful monitoring,” they said.
Dr. Wheat and her associates declared they had no conflicts of interest.
cnellist@frontlinemedcom.com
Don’t use combination antifungal/corticosteroid medications in children or for treating diaper dermatitis, warned Chikoti M. Wheat, MD, of Johns Hopkins University, Baltimore, and her associates.
Lotrisone is a combination product with a high-potency topical corticosteroid, betamethasone dipropionate 0.05% cream, and a topical antifungal agent, clotrimazole 1% cream. The Food and Drug Administration does not recommend it for the population and indication mentioned above, yet it is often used so off-label, Dr. Wheat and her associates said. Mycolog-II, a combination antifungal/corticosteroid with nystatin, an antiyeast agent, and triamcinolone, a medium-potency topical steroid, was taken off the market in 2015, but patients may still have some that they are inclined to use (J Pediatr. 2017. doi: 0.1016/j.jpeds.2017.03.031).
In a study of 9,797 patients aged 0-14 years who were prescribed either Lotrisone or Mycolog-II creams from 2007 to 2014, pediatricians were most likely to prescribe the combination creams (mean, 810 patients), followed by family physicians (mean, 309 patients), and dermatologists (mean, 49 patients). No pediatric dermatologists prescribed either cream.
Why are these combination creams being used?
Sometimes a fungal infection induces an inflammatory dermatitis. In these cases the use of both an antifungal and a corticosteroid with careful monitoring can benefit the patient, the researchers said. “Research, however, has shown that when combination antifungal/corticosteroid agents are used for fungal infections, they not only result in high rates of recurrence of fungal infections but also have greater side effect profiles.”
Also, in 1984, Lotrisone was approved by the FDA for treating tinea corporis, tinea pedis, and tinea cruris in patients older than 12 years. However, lack of efficacy and severe adverse effects including hypothalamic-pituitary-adrenal axis suppression, Cushing syndrome, hyperglycemia, hirsutism, delayed growth, and skin atrophy led the FDA to recommend that Lotrisone not be prescribed for patients younger than 17 years and not be prescribed to treat diaper dermatitis.
So what should you do?
Dr. Wheat and her associates recommend a single-agent topical antifungal to treat superficial fungal infection. If there is intense itching due to infection-induced dermatitis, add a low- or medium-potency topical corticosteroid for just 7-10 days.
For diaper dermatitis with a confirmed secondary fungal infection, they recommend a topical antifungal agent in combination with a barrier cream. “If intense inflammatory changes are present, a low- to medium-potency topical corticosteroid can be used up to twice daily and tapered over 1-2 weeks with careful monitoring,” they said.
Dr. Wheat and her associates declared they had no conflicts of interest.
cnellist@frontlinemedcom.com
FROM THE JOURNAL OF PEDIATRICS
Key clinical point:
Major finding: Pediatricians were most likely to prescribe the combination creams (mean, 810 patients), followed by family physicians (mean, 309 patients), dermatologists (mean, 49 patients), and pediatric dermatologists (none).
Data source: A study of 9,797 patients aged 0-14 years who were prescribed either Lotrisone or Mycolog-II creams from 2007 to 2014.
Disclosures: Dr. Wheat and her associates declared they had no conflicts of interest.
Consider S. pyogenes in cases of pediatric intertrigo
Beefy-red, well demarcated lesions in skin folds without satellite lesions are the clinical signs of intertrigo, and Streptococcus pyogenes may be the cause, said Anca Chiriac, MD, PhD, of Apollonia University, Iasi, Romania, and her associates.
Intertrigo is frequently misdiagnosed in young children, and S. pyogenes skin infections often are misdiagnosed or overlooked. A case series of six children under 9 years of age was discussed in which the children presented with intense erythematous patches that often were pruritic occurring around the anus, in and around the umbilicus, on the vulva, in the intertriginous folds of the neck, in the toe web, and in the antecubital fossa.
The skin lesions often were misdiagnosed as contact dermatitis or atopic dermatitis or a fungal infection, and in several cases they were treated with potent corticosteroids, which aggravated the problem, or a topical antifungal, which had no effect. Swabs for bacterial culture identified S. pyogenes, and courses of oral antibiotics such as penicillin, amoxicillin, or ceftriaxone led to rapid improvement.
S. pyogenes skin infections complications include septicemia, arthritis, osteomyelitis, pneumonia, and toxic shock syndrome. “It is our practice to perform urinalysis because of the risk of poststreptococcal glomerulonephritis,” Dr. Chiriac and her associates said. They recommended penicillin or cephalosporin in age-related doses, or erythromycin or clindamycin if children are allergic to penicillin.
Read more at (J Pediatr. 2017 May;184:230-1).
cnellist@frontlinemedcom.com
Beefy-red, well demarcated lesions in skin folds without satellite lesions are the clinical signs of intertrigo, and Streptococcus pyogenes may be the cause, said Anca Chiriac, MD, PhD, of Apollonia University, Iasi, Romania, and her associates.
Intertrigo is frequently misdiagnosed in young children, and S. pyogenes skin infections often are misdiagnosed or overlooked. A case series of six children under 9 years of age was discussed in which the children presented with intense erythematous patches that often were pruritic occurring around the anus, in and around the umbilicus, on the vulva, in the intertriginous folds of the neck, in the toe web, and in the antecubital fossa.
The skin lesions often were misdiagnosed as contact dermatitis or atopic dermatitis or a fungal infection, and in several cases they were treated with potent corticosteroids, which aggravated the problem, or a topical antifungal, which had no effect. Swabs for bacterial culture identified S. pyogenes, and courses of oral antibiotics such as penicillin, amoxicillin, or ceftriaxone led to rapid improvement.
S. pyogenes skin infections complications include septicemia, arthritis, osteomyelitis, pneumonia, and toxic shock syndrome. “It is our practice to perform urinalysis because of the risk of poststreptococcal glomerulonephritis,” Dr. Chiriac and her associates said. They recommended penicillin or cephalosporin in age-related doses, or erythromycin or clindamycin if children are allergic to penicillin.
Read more at (J Pediatr. 2017 May;184:230-1).
cnellist@frontlinemedcom.com
Beefy-red, well demarcated lesions in skin folds without satellite lesions are the clinical signs of intertrigo, and Streptococcus pyogenes may be the cause, said Anca Chiriac, MD, PhD, of Apollonia University, Iasi, Romania, and her associates.
Intertrigo is frequently misdiagnosed in young children, and S. pyogenes skin infections often are misdiagnosed or overlooked. A case series of six children under 9 years of age was discussed in which the children presented with intense erythematous patches that often were pruritic occurring around the anus, in and around the umbilicus, on the vulva, in the intertriginous folds of the neck, in the toe web, and in the antecubital fossa.
The skin lesions often were misdiagnosed as contact dermatitis or atopic dermatitis or a fungal infection, and in several cases they were treated with potent corticosteroids, which aggravated the problem, or a topical antifungal, which had no effect. Swabs for bacterial culture identified S. pyogenes, and courses of oral antibiotics such as penicillin, amoxicillin, or ceftriaxone led to rapid improvement.
S. pyogenes skin infections complications include septicemia, arthritis, osteomyelitis, pneumonia, and toxic shock syndrome. “It is our practice to perform urinalysis because of the risk of poststreptococcal glomerulonephritis,” Dr. Chiriac and her associates said. They recommended penicillin or cephalosporin in age-related doses, or erythromycin or clindamycin if children are allergic to penicillin.
Read more at (J Pediatr. 2017 May;184:230-1).
cnellist@frontlinemedcom.com
FROM THE JOURNAL OF PEDIATRICS
HM17 session summary: Focus on POCUS – Introduction to Point-of-Care Ultrasound for pediatric hospitalists
Presenters
Nilam Soni, MD, FHM; Thomas Conlon, MD; Ria Dancel, MD, FAAP, FHM; Daniel Schnobrich, MD
Summary
Point-of-care ultrasound (POCUS) is rapidly gaining acceptance in the medical community as a goal-directed examination that answers a specific diagnostic question or guides a bedside invasive procedure. Adoption by pediatric hospitalists is increasing, aided by multiple training pathways, opportunities for scholarship, and organization development.
The use of POCUS is increasing among nonradiologist physicians due to the expectation for perfection, desire for improved patient experience, and increased availability of ultrasound machines. POCUS is rapid and safe, and can be used serially to monitor, provide procedural guidance, and lead to initiation of appropriate therapies.
Training in POCUS in limited applications is possible in short periods of time. One recent study showed that approximately 40% of POCUS cases led to new findings or alteration of treatment. However, POCUS requires training, monitoring for competence, transparency of training/competence, and a QA process that supports the training. One solution at Children’s Hospital of Philadelphia was to use American College of Emergency Physician guidelines for POCUS training.
Pediatric applications include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia and associated parapneumonic effusion, and IV placement. More advanced applications include diagnosis of appendicitis, intussusception, and increased intracranial pressure. Novel applications conceived by nonradiologist physicians have included sinus ultrasound.
Initial training can be provided by “in-house experts,” such as pediatric ED physicians and PICU physicians. Alternatively, an on-site commercial course can be arranged for larger groups. Consideration should be given to mentorship, with comparison to formal imaging and/or clinical progression. Relationships with traditional imagers should be cultivated, as POCUS can potentially be misunderstood. In fact, formal US utilization has been found to increase once clinicals begin to use POCUS.
Key takeaways for HM
- Point-of-care ultrasound (POCUS) is rapidly being adopted by pediatric hospitalists.
- Pediatric applications are still being developed, but include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia/associated effusions, and IV placement.
- Initial training can be provided by pediatric ED physicians/PICU physicians or an on-site commercial course can be arranged for larger groups.
- Relationships with radiologists should be established at the outset to avoid misunderstanding of POCUS.
Dr. Chang is a pediatric hospitalist at Baystate Children’s Hospital and is the pediatric editor of The Hospitalist.
Presenters
Nilam Soni, MD, FHM; Thomas Conlon, MD; Ria Dancel, MD, FAAP, FHM; Daniel Schnobrich, MD
Summary
Point-of-care ultrasound (POCUS) is rapidly gaining acceptance in the medical community as a goal-directed examination that answers a specific diagnostic question or guides a bedside invasive procedure. Adoption by pediatric hospitalists is increasing, aided by multiple training pathways, opportunities for scholarship, and organization development.
The use of POCUS is increasing among nonradiologist physicians due to the expectation for perfection, desire for improved patient experience, and increased availability of ultrasound machines. POCUS is rapid and safe, and can be used serially to monitor, provide procedural guidance, and lead to initiation of appropriate therapies.
Training in POCUS in limited applications is possible in short periods of time. One recent study showed that approximately 40% of POCUS cases led to new findings or alteration of treatment. However, POCUS requires training, monitoring for competence, transparency of training/competence, and a QA process that supports the training. One solution at Children’s Hospital of Philadelphia was to use American College of Emergency Physician guidelines for POCUS training.
Pediatric applications include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia and associated parapneumonic effusion, and IV placement. More advanced applications include diagnosis of appendicitis, intussusception, and increased intracranial pressure. Novel applications conceived by nonradiologist physicians have included sinus ultrasound.
Initial training can be provided by “in-house experts,” such as pediatric ED physicians and PICU physicians. Alternatively, an on-site commercial course can be arranged for larger groups. Consideration should be given to mentorship, with comparison to formal imaging and/or clinical progression. Relationships with traditional imagers should be cultivated, as POCUS can potentially be misunderstood. In fact, formal US utilization has been found to increase once clinicals begin to use POCUS.
Key takeaways for HM
- Point-of-care ultrasound (POCUS) is rapidly being adopted by pediatric hospitalists.
- Pediatric applications are still being developed, but include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia/associated effusions, and IV placement.
- Initial training can be provided by pediatric ED physicians/PICU physicians or an on-site commercial course can be arranged for larger groups.
- Relationships with radiologists should be established at the outset to avoid misunderstanding of POCUS.
Dr. Chang is a pediatric hospitalist at Baystate Children’s Hospital and is the pediatric editor of The Hospitalist.
Presenters
Nilam Soni, MD, FHM; Thomas Conlon, MD; Ria Dancel, MD, FAAP, FHM; Daniel Schnobrich, MD
Summary
Point-of-care ultrasound (POCUS) is rapidly gaining acceptance in the medical community as a goal-directed examination that answers a specific diagnostic question or guides a bedside invasive procedure. Adoption by pediatric hospitalists is increasing, aided by multiple training pathways, opportunities for scholarship, and organization development.
The use of POCUS is increasing among nonradiologist physicians due to the expectation for perfection, desire for improved patient experience, and increased availability of ultrasound machines. POCUS is rapid and safe, and can be used serially to monitor, provide procedural guidance, and lead to initiation of appropriate therapies.
Training in POCUS in limited applications is possible in short periods of time. One recent study showed that approximately 40% of POCUS cases led to new findings or alteration of treatment. However, POCUS requires training, monitoring for competence, transparency of training/competence, and a QA process that supports the training. One solution at Children’s Hospital of Philadelphia was to use American College of Emergency Physician guidelines for POCUS training.
Pediatric applications include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia and associated parapneumonic effusion, and IV placement. More advanced applications include diagnosis of appendicitis, intussusception, and increased intracranial pressure. Novel applications conceived by nonradiologist physicians have included sinus ultrasound.
Initial training can be provided by “in-house experts,” such as pediatric ED physicians and PICU physicians. Alternatively, an on-site commercial course can be arranged for larger groups. Consideration should be given to mentorship, with comparison to formal imaging and/or clinical progression. Relationships with traditional imagers should be cultivated, as POCUS can potentially be misunderstood. In fact, formal US utilization has been found to increase once clinicals begin to use POCUS.
Key takeaways for HM
- Point-of-care ultrasound (POCUS) is rapidly being adopted by pediatric hospitalists.
- Pediatric applications are still being developed, but include guidance of bladder catheterization, identifying occult abscesses, diagnosis of pneumonia/associated effusions, and IV placement.
- Initial training can be provided by pediatric ED physicians/PICU physicians or an on-site commercial course can be arranged for larger groups.
- Relationships with radiologists should be established at the outset to avoid misunderstanding of POCUS.
Dr. Chang is a pediatric hospitalist at Baystate Children’s Hospital and is the pediatric editor of The Hospitalist.
New device that treats esophageal atresia in infants has been authorized
The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.
The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.
Cook Medical provided data on 16 patients implanted with Flourish devices. All patients had successful joining of their esophagus within 3-10 days after receiving the device. A total of 13 of the 16 patients developed anastomotic stricture that required a balloon dilation procedure, a stent, or both to repair. Such strictures also occur with traditional surgery.
The Flourish device should not be used in patients older than 1 year. Other potential complications that may occur include stomach or mouth irritation near the catheter insertion sites and gastroesophageal reflux.
Learn more about the study at www.fda.gov/newsevents/newsroom/pressannouncements/ucm558241.htm.
The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.
The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.
Cook Medical provided data on 16 patients implanted with Flourish devices. All patients had successful joining of their esophagus within 3-10 days after receiving the device. A total of 13 of the 16 patients developed anastomotic stricture that required a balloon dilation procedure, a stent, or both to repair. Such strictures also occur with traditional surgery.
The Flourish device should not be used in patients older than 1 year. Other potential complications that may occur include stomach or mouth irritation near the catheter insertion sites and gastroesophageal reflux.
Learn more about the study at www.fda.gov/newsevents/newsroom/pressannouncements/ucm558241.htm.
The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.
The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.
Cook Medical provided data on 16 patients implanted with Flourish devices. All patients had successful joining of their esophagus within 3-10 days after receiving the device. A total of 13 of the 16 patients developed anastomotic stricture that required a balloon dilation procedure, a stent, or both to repair. Such strictures also occur with traditional surgery.
The Flourish device should not be used in patients older than 1 year. Other potential complications that may occur include stomach or mouth irritation near the catheter insertion sites and gastroesophageal reflux.
Learn more about the study at www.fda.gov/newsevents/newsroom/pressannouncements/ucm558241.htm.
Key clinical point:
Major finding: All of the 16 patients implanted with the Flourish device were successfully treated for esophageal atresia.
Data source: Data was provided by Cook Medical under a humanitarian device exemption. A total of 16 patients were implanted with the Flourish device.
Disclosures: This study was sponsored by Cook Medical.
Marijuana-related visits to Colorado ED steadily increasing
SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.
The state legalized medical marijuana use in 2000 and recreational marijuana use in 2014.
“Adolescents with psychiatric illness comprised a large proportion of marijuana exposures,” said lead author George Sam Wang, MD, of the University of Colorado at Denver in Aurora. “Coingestants were common and included ethanol, amphetamines, and opiates,” he said at the Pediatric Academic Societies meeting.
However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.
Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).
During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.
A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.
The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.
Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.
Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.
“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.
Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.
The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.
The state legalized medical marijuana use in 2000 and recreational marijuana use in 2014.
“Adolescents with psychiatric illness comprised a large proportion of marijuana exposures,” said lead author George Sam Wang, MD, of the University of Colorado at Denver in Aurora. “Coingestants were common and included ethanol, amphetamines, and opiates,” he said at the Pediatric Academic Societies meeting.
However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.
Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).
During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.
A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.
The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.
Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.
Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.
“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.
Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.
The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.
The state legalized medical marijuana use in 2000 and recreational marijuana use in 2014.
“Adolescents with psychiatric illness comprised a large proportion of marijuana exposures,” said lead author George Sam Wang, MD, of the University of Colorado at Denver in Aurora. “Coingestants were common and included ethanol, amphetamines, and opiates,” he said at the Pediatric Academic Societies meeting.
However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.
Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).
During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.
A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.
The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.
Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.
Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.
“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.
Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.
The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
FROM PAS 2017
Key clinical point: Visits to the ED and urgent care have steadily increased among adolescents using marijuana in a state with legal recreational marijuana.
Major finding: Visits related to cannabis increased from 2/1,000 ED and urgent care visits in 2009 to 4/1,000 in 2015.
Data source: A retrospective study from 2005 to 2015 of 3,844 Colorado ED and urgent care visits involving adolescents who used marijuana.
Disclosures: The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
Preterm infants at high risk for RSV morbidity without immunoprophylaxis
SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.
Across two RSV seasons at more than 40 study sites, nearly half of preterm infants admitted for lab-confirmed RSV required ICU admission, and one in five required invasive mechanical ventilation.
“Severity of illness and resource utilization are greatest in infants aged less than 3 months,” said John DeVincenzo, MD, professor in the pediatric infectious diseases division at the University of Tennessee, Memphis. “The results from the two seasons were consistent with one another and with previous and recent studies,” he said at the annual Pediatric Academic Societies meeting.
Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.
Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).
New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).
This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.
Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.
Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.
The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.
Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.
A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.
AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.
Across two RSV seasons at more than 40 study sites, nearly half of preterm infants admitted for lab-confirmed RSV required ICU admission, and one in five required invasive mechanical ventilation.
“Severity of illness and resource utilization are greatest in infants aged less than 3 months,” said John DeVincenzo, MD, professor in the pediatric infectious diseases division at the University of Tennessee, Memphis. “The results from the two seasons were consistent with one another and with previous and recent studies,” he said at the annual Pediatric Academic Societies meeting.
Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.
Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).
New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).
This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.
Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.
Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.
The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.
Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.
A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.
AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.
Across two RSV seasons at more than 40 study sites, nearly half of preterm infants admitted for lab-confirmed RSV required ICU admission, and one in five required invasive mechanical ventilation.
“Severity of illness and resource utilization are greatest in infants aged less than 3 months,” said John DeVincenzo, MD, professor in the pediatric infectious diseases division at the University of Tennessee, Memphis. “The results from the two seasons were consistent with one another and with previous and recent studies,” he said at the annual Pediatric Academic Societies meeting.
Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.
Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).
New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).
This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.
Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.
Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.
The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.
Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.
A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.
AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
AT PAS 17
Key clinical point: Preterm infants, particularly those younger than 3 months, can experience severe respiratory syncytial virus (RSV) illness without immunoprophylaxis.
Major finding: Of the 702 preterm infants hospitalized during 2014-2015, 42% went to the ICU and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during 2015-2016 went to the ICU and 19% required mechanical ventilation.
Data source: An analysis of 1,378 preterm infants born at 29-35 weeks’ gestation and hospitalized at under 1 year for lab-confirmed RSV during the 2014-2015 and 2015-2016 RSV seasons.
Disclosures: AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
First generic version of clofarabine available in US
Clofarabine Injection, the first-to-market generic version of Sanofi Genzyme’s Clolar, is now available in the US.
The generic, a product of Fresenius Kabi, is available as a single dose vial containing 20 mg per 20 mL clofarabine.
Clofarabine is a purine nucleoside metabolic inhibitor indicated for the treatment of patients ages 1 to 21 with relapsed or refractory acute lymphoblastic leukemia (ALL) who received at least 2 prior treatment regimens.
Clolar was granted accelerated approval for this indication in the US in 2004.
The approval was based on response rates observed in ALL patients. There are no trials verifying that clofarabine confers improvement in survival or disease-related symptoms in ALL patients.
Clofarabine was assessed in a single-arm, phase 2 trial of 61 pediatric patients with relapsed/refractory ALL.
The patients’ median age was 12 (range, 1 to 20 years), and their median number of prior treatment regimens was 3 (range, 2 to 6).
The patients received clofarabine at 52 mg/m2 intravenously over 2 hours daily for 5 days, every 2 to 6 weeks.
The overall response rate was 30%. Seven patient achieved a complete response (CR), 5 had a CR without platelet recovery, and 6 patients had a partial response.
The median duration of CR in patients who did not go on to hematopoietic stem cell transplant was 6 weeks.
The most common grade 3 or higher adverse events were febrile neutropenia, anorexia, hypotension, and nausea.
These results were published in the Journal of Clinical Oncology in 2006. 
Clofarabine Injection, the first-to-market generic version of Sanofi Genzyme’s Clolar, is now available in the US.
The generic, a product of Fresenius Kabi, is available as a single dose vial containing 20 mg per 20 mL clofarabine.
Clofarabine is a purine nucleoside metabolic inhibitor indicated for the treatment of patients ages 1 to 21 with relapsed or refractory acute lymphoblastic leukemia (ALL) who received at least 2 prior treatment regimens.
Clolar was granted accelerated approval for this indication in the US in 2004.
The approval was based on response rates observed in ALL patients. There are no trials verifying that clofarabine confers improvement in survival or disease-related symptoms in ALL patients.
Clofarabine was assessed in a single-arm, phase 2 trial of 61 pediatric patients with relapsed/refractory ALL.
The patients’ median age was 12 (range, 1 to 20 years), and their median number of prior treatment regimens was 3 (range, 2 to 6).
The patients received clofarabine at 52 mg/m2 intravenously over 2 hours daily for 5 days, every 2 to 6 weeks.
The overall response rate was 30%. Seven patient achieved a complete response (CR), 5 had a CR without platelet recovery, and 6 patients had a partial response.
The median duration of CR in patients who did not go on to hematopoietic stem cell transplant was 6 weeks.
The most common grade 3 or higher adverse events were febrile neutropenia, anorexia, hypotension, and nausea.
These results were published in the Journal of Clinical Oncology in 2006.
Clofarabine Injection, the first-to-market generic version of Sanofi Genzyme’s Clolar, is now available in the US.
The generic, a product of Fresenius Kabi, is available as a single dose vial containing 20 mg per 20 mL clofarabine.
Clofarabine is a purine nucleoside metabolic inhibitor indicated for the treatment of patients ages 1 to 21 with relapsed or refractory acute lymphoblastic leukemia (ALL) who received at least 2 prior treatment regimens.
Clolar was granted accelerated approval for this indication in the US in 2004.
The approval was based on response rates observed in ALL patients. There are no trials verifying that clofarabine confers improvement in survival or disease-related symptoms in ALL patients.
Clofarabine was assessed in a single-arm, phase 2 trial of 61 pediatric patients with relapsed/refractory ALL.
The patients’ median age was 12 (range, 1 to 20 years), and their median number of prior treatment regimens was 3 (range, 2 to 6).
The patients received clofarabine at 52 mg/m2 intravenously over 2 hours daily for 5 days, every 2 to 6 weeks.
The overall response rate was 30%. Seven patient achieved a complete response (CR), 5 had a CR without platelet recovery, and 6 patients had a partial response.
The median duration of CR in patients who did not go on to hematopoietic stem cell transplant was 6 weeks.
The most common grade 3 or higher adverse events were febrile neutropenia, anorexia, hypotension, and nausea.
These results were published in the Journal of Clinical Oncology in 2006.
Adalimumab outperforms methotrexate in treating severe pediatric plaque psoriasis
Adalimumab appears to be a safe and effective treatment option for severe plaque psoriasis in children, outperforming methotrexate, based on the results of a phase III study, said Kim Papp, MD, PhD, of Probity Medical Research, Waterloo, Ont., and his associates.
“To our knowledge, this is the first randomized controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis,” the researchers said, noting that the study did not include a placebo group because of ethical issues related to treating children with a severe chronic disorder.
At week 16 of the initial treatment period, an improvement of at least 75% in the Psoriasis Area and Severity Index (PASI75) score was reached by significantly more of the patients in the 0.8 mg/kg adalimumab group – 22 (58%) – than in the methotrexate group – 12 (32%). In the 0.4-mg/kg adalimumab group, 17 (44%) of patients reached a PASI75. The PASI75 response was rapid in the 0.8 mg/kg adalimumab group, a significant difference, compared with the methotrexate group. It was reached by week 4 (P = .002).
“At week 16, the 26% difference between adalimumab 0.8 mg/kg and methotrexate in the proportion of patients who achieved PASI75 was significant and clinically relevant,” Dr. Papp and his associates concluded.
At week 16 of treatment, the proportion of patients who achieved a physician global assessment (PGA) score of 0 or 1 (clear or minimal) was higher in the adalimumab 0.8 mg/kg group (23 of 38 [61%]) than in the methotrexate group (15 of 37 [41%]) or in the adalimumab 0.4-mg/kg group (16 of 39 [41%]) (P = .083). At week 16, the difference between the adalimumab 0.8-mg/kg and methotrexate groups was not significant, the investigators said (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31189-3).
After the withdrawal period, PASI75 was achieved in 15 of 19 (79%) patients who were initial responders to adalimumab 0.8 mg/kg and 6 of 11 (55%) patients who were initial responders to adalimumab 0.4 mg/kg. PASI75 was achieved in six of eight (75%) patients who had responded to methotrexate treatment in the initial treatment period and who had loss of disease control in the withdrawal period.
During the initial treatment period, adverse events were reported by 26 of 38 (68%) in the adalimumab 0.8-mg/kg group, 30 of 39 (77%) in the adalimumab 0.4-mg/kg group, and 28 of 37 (76%) in the methotrexate group. Infections were the most frequently reported adverse events. Serious adverse events were infrequent, reported by three patients in the adalimumab 0.4-mg/kg group, and were not considered to be related to the study drug, the researchers said. Eleven severe adverse events were reported by 8 of the 114 (7%) children. Of these, headache was the most common. A case of urticaria during retreatment that led to discontinuation of adalimumab in the patient (who had received methotrexate in the first treatment period), was considered by the investigator as “probably related” to adalimumab.
“No new safety risks were identified in our study; however, longer-term data are needed to fully assess the safety profile of adalimumab in the pediatric population,” Dr. Papp and his associates commented.
“Our results showed better quality of life outcomes in children and adolescents treated with adalimumab compared with methotrexate. The mean 10.8-point change in PedsQL [pediatric quality of life inventory] from baseline to week 16 in the adalimumab 0.8-mg/kg group exceeded the minimal clinically important difference of 4.36, whereas the 1.9-point change in the methotrexate group did not,” they noted.
The study was funded by AbbVie, the manufacturer of adalimumab (Humira). Dr. Papp has served as a consultant for AbbVie and a number of other pharmaceutical companies, for which he has served as consultant or speaker or on advisory boards. His associates listed numerous similar disclosures. Two authors were AbbVie employees.
The initial treatment response to adalimumab was quick with “significant clinical difference compared with methotrexate seen as early as 4 weeks.” Improvement in the pediatric quality of life inventory (PedsQL) score from baseline “was significantly greater” in children in the adalimumab 0.8-mg/kg group than in children in the methotrexate group. Adalimumab provided “several clinically and statistically significant improvements” in children with severe plaque psoriasis, compared with methotrexate.
However, further studies are needed to determine both the short-term and long-term effectiveness and the safety of systemic treatments in children and adolescents with psoriasis.
Dario Kivelevitch, MD, is a third year dermatology resident, and Alan Menter, MD, is chief of dermatology at Baylor University Medical Center, Dallas. These comments are from an editorial that accompanied the study (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31190-X). Dr. Kivelevitch said he had no relevant financial disclosures. Dr. Menter disclosed grants and personal fees from AbbVie and other pharmaceutical companies, all outside the submitted work.
The initial treatment response to adalimumab was quick with “significant clinical difference compared with methotrexate seen as early as 4 weeks.” Improvement in the pediatric quality of life inventory (PedsQL) score from baseline “was significantly greater” in children in the adalimumab 0.8-mg/kg group than in children in the methotrexate group. Adalimumab provided “several clinically and statistically significant improvements” in children with severe plaque psoriasis, compared with methotrexate.
However, further studies are needed to determine both the short-term and long-term effectiveness and the safety of systemic treatments in children and adolescents with psoriasis.
Dario Kivelevitch, MD, is a third year dermatology resident, and Alan Menter, MD, is chief of dermatology at Baylor University Medical Center, Dallas. These comments are from an editorial that accompanied the study (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31190-X). Dr. Kivelevitch said he had no relevant financial disclosures. Dr. Menter disclosed grants and personal fees from AbbVie and other pharmaceutical companies, all outside the submitted work.
The initial treatment response to adalimumab was quick with “significant clinical difference compared with methotrexate seen as early as 4 weeks.” Improvement in the pediatric quality of life inventory (PedsQL) score from baseline “was significantly greater” in children in the adalimumab 0.8-mg/kg group than in children in the methotrexate group. Adalimumab provided “several clinically and statistically significant improvements” in children with severe plaque psoriasis, compared with methotrexate.
However, further studies are needed to determine both the short-term and long-term effectiveness and the safety of systemic treatments in children and adolescents with psoriasis.
Dario Kivelevitch, MD, is a third year dermatology resident, and Alan Menter, MD, is chief of dermatology at Baylor University Medical Center, Dallas. These comments are from an editorial that accompanied the study (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31190-X). Dr. Kivelevitch said he had no relevant financial disclosures. Dr. Menter disclosed grants and personal fees from AbbVie and other pharmaceutical companies, all outside the submitted work.
Adalimumab appears to be a safe and effective treatment option for severe plaque psoriasis in children, outperforming methotrexate, based on the results of a phase III study, said Kim Papp, MD, PhD, of Probity Medical Research, Waterloo, Ont., and his associates.
“To our knowledge, this is the first randomized controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis,” the researchers said, noting that the study did not include a placebo group because of ethical issues related to treating children with a severe chronic disorder.
At week 16 of the initial treatment period, an improvement of at least 75% in the Psoriasis Area and Severity Index (PASI75) score was reached by significantly more of the patients in the 0.8 mg/kg adalimumab group – 22 (58%) – than in the methotrexate group – 12 (32%). In the 0.4-mg/kg adalimumab group, 17 (44%) of patients reached a PASI75. The PASI75 response was rapid in the 0.8 mg/kg adalimumab group, a significant difference, compared with the methotrexate group. It was reached by week 4 (P = .002).
“At week 16, the 26% difference between adalimumab 0.8 mg/kg and methotrexate in the proportion of patients who achieved PASI75 was significant and clinically relevant,” Dr. Papp and his associates concluded.
At week 16 of treatment, the proportion of patients who achieved a physician global assessment (PGA) score of 0 or 1 (clear or minimal) was higher in the adalimumab 0.8 mg/kg group (23 of 38 [61%]) than in the methotrexate group (15 of 37 [41%]) or in the adalimumab 0.4-mg/kg group (16 of 39 [41%]) (P = .083). At week 16, the difference between the adalimumab 0.8-mg/kg and methotrexate groups was not significant, the investigators said (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31189-3).
After the withdrawal period, PASI75 was achieved in 15 of 19 (79%) patients who were initial responders to adalimumab 0.8 mg/kg and 6 of 11 (55%) patients who were initial responders to adalimumab 0.4 mg/kg. PASI75 was achieved in six of eight (75%) patients who had responded to methotrexate treatment in the initial treatment period and who had loss of disease control in the withdrawal period.
During the initial treatment period, adverse events were reported by 26 of 38 (68%) in the adalimumab 0.8-mg/kg group, 30 of 39 (77%) in the adalimumab 0.4-mg/kg group, and 28 of 37 (76%) in the methotrexate group. Infections were the most frequently reported adverse events. Serious adverse events were infrequent, reported by three patients in the adalimumab 0.4-mg/kg group, and were not considered to be related to the study drug, the researchers said. Eleven severe adverse events were reported by 8 of the 114 (7%) children. Of these, headache was the most common. A case of urticaria during retreatment that led to discontinuation of adalimumab in the patient (who had received methotrexate in the first treatment period), was considered by the investigator as “probably related” to adalimumab.
“No new safety risks were identified in our study; however, longer-term data are needed to fully assess the safety profile of adalimumab in the pediatric population,” Dr. Papp and his associates commented.
“Our results showed better quality of life outcomes in children and adolescents treated with adalimumab compared with methotrexate. The mean 10.8-point change in PedsQL [pediatric quality of life inventory] from baseline to week 16 in the adalimumab 0.8-mg/kg group exceeded the minimal clinically important difference of 4.36, whereas the 1.9-point change in the methotrexate group did not,” they noted.
The study was funded by AbbVie, the manufacturer of adalimumab (Humira). Dr. Papp has served as a consultant for AbbVie and a number of other pharmaceutical companies, for which he has served as consultant or speaker or on advisory boards. His associates listed numerous similar disclosures. Two authors were AbbVie employees.
Adalimumab appears to be a safe and effective treatment option for severe plaque psoriasis in children, outperforming methotrexate, based on the results of a phase III study, said Kim Papp, MD, PhD, of Probity Medical Research, Waterloo, Ont., and his associates.
“To our knowledge, this is the first randomized controlled study of either adalimumab or methotrexate in children and adolescents with psoriasis,” the researchers said, noting that the study did not include a placebo group because of ethical issues related to treating children with a severe chronic disorder.
At week 16 of the initial treatment period, an improvement of at least 75% in the Psoriasis Area and Severity Index (PASI75) score was reached by significantly more of the patients in the 0.8 mg/kg adalimumab group – 22 (58%) – than in the methotrexate group – 12 (32%). In the 0.4-mg/kg adalimumab group, 17 (44%) of patients reached a PASI75. The PASI75 response was rapid in the 0.8 mg/kg adalimumab group, a significant difference, compared with the methotrexate group. It was reached by week 4 (P = .002).
“At week 16, the 26% difference between adalimumab 0.8 mg/kg and methotrexate in the proportion of patients who achieved PASI75 was significant and clinically relevant,” Dr. Papp and his associates concluded.
At week 16 of treatment, the proportion of patients who achieved a physician global assessment (PGA) score of 0 or 1 (clear or minimal) was higher in the adalimumab 0.8 mg/kg group (23 of 38 [61%]) than in the methotrexate group (15 of 37 [41%]) or in the adalimumab 0.4-mg/kg group (16 of 39 [41%]) (P = .083). At week 16, the difference between the adalimumab 0.8-mg/kg and methotrexate groups was not significant, the investigators said (Lancet. 2017. doi: 10.1016/ S0140-6736[17]31189-3).
After the withdrawal period, PASI75 was achieved in 15 of 19 (79%) patients who were initial responders to adalimumab 0.8 mg/kg and 6 of 11 (55%) patients who were initial responders to adalimumab 0.4 mg/kg. PASI75 was achieved in six of eight (75%) patients who had responded to methotrexate treatment in the initial treatment period and who had loss of disease control in the withdrawal period.
During the initial treatment period, adverse events were reported by 26 of 38 (68%) in the adalimumab 0.8-mg/kg group, 30 of 39 (77%) in the adalimumab 0.4-mg/kg group, and 28 of 37 (76%) in the methotrexate group. Infections were the most frequently reported adverse events. Serious adverse events were infrequent, reported by three patients in the adalimumab 0.4-mg/kg group, and were not considered to be related to the study drug, the researchers said. Eleven severe adverse events were reported by 8 of the 114 (7%) children. Of these, headache was the most common. A case of urticaria during retreatment that led to discontinuation of adalimumab in the patient (who had received methotrexate in the first treatment period), was considered by the investigator as “probably related” to adalimumab.
“No new safety risks were identified in our study; however, longer-term data are needed to fully assess the safety profile of adalimumab in the pediatric population,” Dr. Papp and his associates commented.
“Our results showed better quality of life outcomes in children and adolescents treated with adalimumab compared with methotrexate. The mean 10.8-point change in PedsQL [pediatric quality of life inventory] from baseline to week 16 in the adalimumab 0.8-mg/kg group exceeded the minimal clinically important difference of 4.36, whereas the 1.9-point change in the methotrexate group did not,” they noted.
The study was funded by AbbVie, the manufacturer of adalimumab (Humira). Dr. Papp has served as a consultant for AbbVie and a number of other pharmaceutical companies, for which he has served as consultant or speaker or on advisory boards. His associates listed numerous similar disclosures. Two authors were AbbVie employees.
FROM THE LANCET
Key clinical point:
Major finding: At week 16 of the initial treatment period, Psoriasis Area and Severity Index (PASI)175 was reached by significantly more of the patients in the 0.8 mg/kg adalimumab group (22 of 38 [58%]) than in the methotrexate group (12 of 37 [32%]).
Data source: A double-blind, phase III trial was done at 38 clinics in 13 countries with 114 children aged 4-17 years, with severe plaque psoriasis that had not responded to topical therapy.
Disclosures: The study was funded by AbbVie. Dr. Papp has served as a consultant for adalimumab manufacturer AbbVie and a number of other pharmaceutical companies for which he has served as consultant or speaker or on advisory boards. His associates listed numerous similar disclosures. Two authors were AbbVie employees.
HPV vaccine training video improved provider knowledge, confidence
SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.
“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.
Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.
“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.
She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.
The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.
The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.
Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.
Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).
Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).
The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.
Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).
Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.
Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
• Making a strong recommendation for the HPV vaccine.
• Discussing HPV vaccination again with a family who has previously declined it.
• Facilitating completion of a three-dose vaccine series once initiated.
• Presenting the HPV vaccine as a cancer-prevention vaccine.
• Addressing parental concerns about safety and side effects.
• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.
• Counseling about the need to routinely vaccinate boys against HPV.
• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.
“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.
She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.
The study was funded by an American Academy of Pediatrics Adolescent Vaccinations and Wellness Education Grant, supported by Merck. Dr. Kumar had no relevant financial disclosures.
SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.
“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.
Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.
“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.
She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.
The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.
The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.
Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.
Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).
Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).
The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.
Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).
Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.
Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
• Making a strong recommendation for the HPV vaccine.
• Discussing HPV vaccination again with a family who has previously declined it.
• Facilitating completion of a three-dose vaccine series once initiated.
• Presenting the HPV vaccine as a cancer-prevention vaccine.
• Addressing parental concerns about safety and side effects.
• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.
• Counseling about the need to routinely vaccinate boys against HPV.
• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.
“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.
She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.
The study was funded by an American Academy of Pediatrics Adolescent Vaccinations and Wellness Education Grant, supported by Merck. Dr. Kumar had no relevant financial disclosures.
SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.
“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.
Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.
“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.
She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.
The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.
The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.
Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.
Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).
Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).
The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.
Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).
Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.
Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
• Making a strong recommendation for the HPV vaccine.
• Discussing HPV vaccination again with a family who has previously declined it.
• Facilitating completion of a three-dose vaccine series once initiated.
• Presenting the HPV vaccine as a cancer-prevention vaccine.
• Addressing parental concerns about safety and side effects.
• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.
• Counseling about the need to routinely vaccinate boys against HPV.
• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.
“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.
She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.
The study was funded by an American Academy of Pediatrics Adolescent Vaccinations and Wellness Education Grant, supported by Merck. Dr. Kumar had no relevant financial disclosures.
Key clinical point:
Major finding: Statistically significant improvements occurred among providers for five questions on HPV vaccine knowledge, six questions about attitudes toward the vaccine, and all eight questions concerning self-assessed skills in counseling families about the vaccine.
Data source: The findings are based on a cohort of 109 California pediatric providers whose knowledge, attitudes, and self-reported skills were assessed before and after the intervention.
Disclosures: The study was funded by an American Academy of Pediatrics Adolescent Vaccinations and Wellness Education Grant, supported by Merck. Dr. Kumar had no relevant financial disclosures.
FDA: Some blood lead tests have reported falsely low levels since 2014
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal
The Food and Drug Administration is recommending repeat lead testing of young children and at-risk women who were tested via a venous blood sample. The recommendation was issued May 17 after the agency discovered a probable 3-year history of inaccurate tests by the nation’s largest lead test distributor.
The tests should be repeated with a capillary sample in children younger than 6 years of age as of May 17, and all pregnant or breastfeeding women who had a lead level of 10 mcg/dL or lower in a venous blood draw tested with any system made by Magellan Diagnostics, FDA representatives said during at a press briefing.
“We do have evidence of a problem with falsely lower lead reading with venous blood,” said Dr. Shuren, director of the FDA Center for Devices and Radiological Health. “Based on the information we have now, we don’t know how often we see this inaccuracy in samples, or how much lower it is. There is a wide variation and a small amount of data. We need to do further testing to see how big the problem is and the root cause. However, we do have enough data to be confident that we don’t have the problem in capillary blood.”
The warning includes all tests run on four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. All LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system – one found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not now believed to be affected.
At this point, Magellan isn’t required to pay for any retesting. Tim Hill, acting director of the Center for Medicaid and CHIP Services, who was also on the call, confirmed that retesting will be covered for Medicaid and CHIP recipients. Patients with private insurance will have to contact their insurance companies to ascertain coverage, he said.
“Our first priority is to be sure folks get retested through our programs,” Mr. Hill said during the briefing. “We don’t want reimbursement to hold up the retesting. My understanding is that talks with Magellan with regard to their liability are ongoing.”
Regulators discovered the extent of the problem in March, after Magellan submitted a 510(k) premarket notification for a new iteration of its point-of-care test, FDA spokesperson Tara Goodin said in an interview. The new product was based on a kit approved in 2013, so all tests run on venous blood since then are in question.
During the data review, FDA discovered that customers began complaining to Magellan about inaccurate results on venous blood in 2014. Magellan issued three customer notifications letters (primarily to laboratories) alerting them to testing inaccuracies and recommending mitigations designed to address them. These customer notifications were issued on Nov. 24, 2014; Nov. 4, 2016; and April 28, 2017. In these, the company indicated that about 2.5% of patients whose tests were below the level of medical concern could actually have enough lead to warrant intervention. Magellan suggested that the problem could be solved by holding all samples for 24 hours before mixing them with the reagent – a step the company said would reduce risk of a misread to zero.
Regulators disagreed, Ms. Goodin said.
“Based on available information, the FDA believes that Magellan should have determined that the risk of an inaccurate test result and the number of people that could be adversely affected was much higher than they estimated and that their mitigation might not be adequate to address the increased risk. Instead, the company submitted a malfunction report in 2015 related to an observed increased frequency of falsely low test results in the LeadCare Ultra system that the firm indicated it first identified through the August 2014 complaint.”
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The scope of the problem became apparent only after Magellan submitted its 510(k) paperwork in March, Ms. Goodin said.
“After reviewing initial data available from Magellan on these inaccuracies and their mitigations, the FDA was unable to identify the root cause of the inaccuracies, the frequency and extent of the inaccuracies, or to confirm that the mitigations are effective. While the FDA’s investigation is in its early stages, we did not want to delay warning health care professionals and laboratories about the risk of testing inaccuracies and encouraging parents and at-risk adults to follow the CDC’s recommendations.”
As soon as FDA identified the issue as a potential public health risk, it began working with the Centers for Medicare & Medicaid Services to issue recommendations for laboratories, health care professionals, and at-risk individuals.
“The FDA prioritized communicating to the public about this issue but is also aggressively investigating this issue to determine the cause of the inaccurate results and will provide updates as more is learned,” Ms. Goodin said. “This includes reviewing data provided by the company, requesting additional information from Magellan regarding the issue, and inspecting the company’s facility. The FDA has also requested an independent analysis of the test. We are aggressively investigating this issue and have already sent staff to inspect Magellan’s facility.”
Phone calls to Magellan for clarification on its mitigation procedures, the potential impact on customers, and the history of the LeadCare series’ approvals were not returned at press time, and the company had no prepared statement. A safety communication was posted to its website.
Since 2014, Magellan has run 8 million blood lead tests. Based on the company’s 2.5% estimate of misreads, 200,000 patients tested with the kit could have dangerously high blood lead levels. Currently, the FDA has no official estimate of how many tests were run on venous blood, how many of those returned inaccurate results, or even what caused the tests to read out with falsely low levels, Dr. Shuren said.
“We are investigating the cause, however when [Magellan’s prior test kits] came on the market, there was data supporting their accuracy. The root cause of this, we don’t know. It may not be specific to the test; it may have to do with the tubes, the reactions with chemicals, the way it’s processed. We are looking into all [of] these.”
On Twitter @Alz_gal