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peter doshi :: Article Creator New Research Reports On Financial Entanglements Between FDA Chiefs And The Drug Industry An investigation published by The BMJ today raises concerns about financial entanglements between US Food and Drug Administration (FDA) chiefs and the drug and medical device companies they are responsible for regulating. Regulations prohibit FDA employees from holding financial interests in any FDA "significantly regulated organization" and the FDA says it takes conflicts of interest seriously, but Peter Doshi, senior editor at The BMJ, finds that financial interests with the drug industry are common among its leaders. Doshi reports that nine of the FDA's past 10 commissioners went on to work for the drug industry or serve on the board of directors of a drug company. That includes Margaret Hamburg, who led FDA between 2009 and 2015, but whose story is less well known. Like her colleagues, Margaret Hamburg h

85% hepatitis B vaccine coverage for infants: 'It takes a lot to get there' - Healio

Photo of Katherine Pelts 

Katherine Pelts

Photo of Jina Park 

Jina Park

NEW ORLEANS — Quality improvement projects focused on education and multidisciplinary cooperation have been successful at improving hepatitis B vaccination rates among neonates, according to a pair of studies presented at the AAP National Conference & Exhibition.

In 2017, the AAP recommended that all medically stable infants should be given an HBV vaccine as routine prophylaxis within the first 24 hours after birth. Even though a vaccine has been available since 1982, approximately 1,000 perinatal HBV infections occur each year in the United States. These infections can have serious consequences — approximately 90% of babies infected at birth will go on to develop chronic disease, and one-quarter will die prematurely from complications, according to researchers.

At two separate institutions, clinicians launched QI projects to increase rates of the HBV vaccine birth dose to at least 85%, which is in line with a Healthy People 2020 goal. Both organizations focused heavily on educating providers and parents about the vaccine, and both stressed the importance of cooperation between physicians and nurses to ensure that babies are given the HBV vaccine within 24 hours of birth, if not earlier.

Katherine Pelts, MD , from the department of pediatrics at Richmond University Medical Center in Staten Island, New York, told Infectious Diseases in Children that before an initiative took place at her institution, the vaccination rate was at about 52% overall. The rate fluctuated throughout the next 3 years, but with “continued education of nursing and parents” it eventually held steady at round 70%, she said. The rate of vaccination within the first 12 hours of life — another target of their QI program — increased from 19% to 43%.

To boost the immunization rate even more, Pelts said that obstetricians are being asked to discuss the vaccine with parents before delivery.

“As crazy as it sounds, a lot of parents aren’t even aware of the vaccine,” she said.

Pelts explained that many parents come to the hospital ready with their own “birth plans,” which can interfere with the staff’s efforts to increase vaccination rates.

“A lot of parents come with plans already, and they have this notion that vaccines are bad, and there’s a lot of vaccine hesitancy at that point,” she said. “I think addressing their concerns, even though they have these plans, is a big step for us.”

Pelts and colleagues found that 98% of parents who refused vaccination for their infants followed up in a private pediatrician’s office after discharge rather than doing so at their hospital — another potential roadblock to improving rates.

To address vaccine hesitancy, Pelts’ institution created a health care provider toolkit, which includes accurate information about vaccines and research studies. Parents are also required to sign “vaccine refusal forms” if they opt out, and they must state their reasons for doing so.

“Our goal is 85%, and it takes a lot to get there,” Pelts said.

Jina Park, MD, a chief resident at Kaiser Permanente, and colleagues initiated a similar QI project in Northern California. Park told Infectious Diseases in Children that when she was a PGY-1 resident, she noticed an alarming pattern: many newborns were not receiving the HBV vaccine.

“When I asked parents why they declined the neonatal HepB vaccine during the newborn hospital admission, many parents had clear reasons why, and many did not. Some did not even remember that they declined,” she said.

Before the intervention, Park said monthly rates hovered around 70%. However, about 6 months after the QI project launched, rates approached 90%.

Park said vaccine hesitancy is a problem at her institution, too.

“We live in an area — Oakland, California — where vaccine hesitancy is a real issue,” she said. “We tried to address this by educating the nurses to present the vaccine as a statement rather than a question, as many studies have shown that when vaccination is presented as a statement, many more are likely to vaccinate their child.”

Park said the continued education of front-line health care providers will be essential to shore up the important gains they have made. Part of her QI project included question and answer sessions, supplying research articles, posting fliers about HBV vaccination in staff breakrooms and leaving reminders at all computer workstations to immunize infants against HBV.

The vaccination policy at Park’s hospital is likely similar to those of other institutions, so the results are generalizable.

“I think the strategies we used can most definitely be implemented in other institutions,” she said. “We are also hoping that by educating the bedside nurses with the evidence, they can educate other medical providers as well as parents about the importance of the neonatal HepB vaccine to help carry this improvement forward. Also, many of our bedside nurses are traveling nurses, and they work at other institutions; our hope is that they take the knowledge with them to other hospitals and apply it to future conversations.”

Park stressed that the biggest factor for success in boosting vaccination rates is multidisciplinary cooperation.

“The most difficult step was obtaining nursing leadership buy-in and support — and this was really the crucial turning point for success,” she said. – by John Schoen and Katherine Bortz

References:

AAP Committee on Infectious Diseases; AAP Committee on Fetus and Newborn. Pediatrics. 2017;doi:10.1542/peds.2017-1870.

Pelts K, et al. 2020 Hepatitis B birth dose and timely vaccination goals: Are we there yet? Presented at: AAP National Conference & Exhibition; Oct. 25-29, 2019; New Orleans.

Park J, et al. Improving the neonatal hepatitis B vaccination rate through an interdisciplinary, multi-pronged approach. Presented at: AAP National Conference & Exhibition; Oct. 25-29, 2019; New Orleans.

Disclosures: Pelts and Park report no relevant financial disclosures.

Photo of Katherine Pelts 

Katherine Pelts

Photo of Jina Park 

Jina Park

NEW ORLEANS — Quality improvement projects focused on education and multidisciplinary cooperation have been successful at improving hepatitis B vaccination rates among neonates, according to a pair of studies presented at the AAP National Conference & Exhibition.

In 2017, the AAP recommended that all medically stable infants should be given an HBV vaccine as routine prophylaxis within the first 24 hours after birth. Even though a vaccine has been available since 1982, approximately 1,000 perinatal HBV infections occur each year in the United States. These infections can have serious consequences — approximately 90% of babies infected at birth will go on to develop chronic disease, and one-quarter will die prematurely from complications, according to researchers.

At two separate institutions, clinicians launched QI projects to increase rates of the HBV vaccine birth dose to at least 85%, which is in line with a Healthy People 2020 goal. Both organizations focused heavily on educating providers and parents about the vaccine, and both stressed the importance of cooperation between physicians and nurses to ensure that babies are given the HBV vaccine within 24 hours of birth, if not earlier.

Katherine Pelts, MD , from the department of pediatrics at Richmond University Medical Center in Staten Island, New York, told Infectious Diseases in Children that before an initiative took place at her institution, the vaccination rate was at about 52% overall. The rate fluctuated throughout the next 3 years, but with “continued education of nursing and parents” it eventually held steady at round 70%, she said. The rate of vaccination within the first 12 hours of life — another target of their QI program — increased from 19% to 43%.

To boost the immunization rate even more, Pelts said that obstetricians are being asked to discuss the vaccine with parents before delivery.

“As crazy as it sounds, a lot of parents aren’t even aware of the vaccine,” she said.

Pelts explained that many parents come to the hospital ready with their own “birth plans,” which can interfere with the staff’s efforts to increase vaccination rates.

“A lot of parents come with plans already, and they have this notion that vaccines are bad, and there’s a lot of vaccine hesitancy at that point,” she said. “I think addressing their concerns, even though they have these plans, is a big step for us.”

Pelts and colleagues found that 98% of parents who refused vaccination for their infants followed up in a private pediatrician’s office after discharge rather than doing so at their hospital — another potential roadblock to improving rates.

To address vaccine hesitancy, Pelts’ institution created a health care provider toolkit, which includes accurate information about vaccines and research studies. Parents are also required to sign “vaccine refusal forms” if they opt out, and they must state their reasons for doing so.

“Our goal is 85%, and it takes a lot to get there,” Pelts said.

Jina Park, MD, a chief resident at Kaiser Permanente, and colleagues initiated a similar QI project in Northern California. Park told Infectious Diseases in Children that when she was a PGY-1 resident, she noticed an alarming pattern: many newborns were not receiving the HBV vaccine.

PAGE BREAK

“When I asked parents why they declined the neonatal HepB vaccine during the newborn hospital admission, many parents had clear reasons why, and many did not. Some did not even remember that they declined,” she said.

Before the intervention, Park said monthly rates hovered around 70%. However, about 6 months after the QI project launched, rates approached 90%.

Park said vaccine hesitancy is a problem at her institution, too.

“We live in an area — Oakland, California — where vaccine hesitancy is a real issue,” she said. “We tried to address this by educating the nurses to present the vaccine as a statement rather than a question, as many studies have shown that when vaccination is presented as a statement, many more are likely to vaccinate their child.”

Park said the continued education of front-line health care providers will be essential to shore up the important gains they have made. Part of her QI project included question and answer sessions, supplying research articles, posting fliers about HBV vaccination in staff breakrooms and leaving reminders at all computer workstations to immunize infants against HBV.

The vaccination policy at Park’s hospital is likely similar to those of other institutions, so the results are generalizable.

“I think the strategies we used can most definitely be implemented in other institutions,” she said. “We are also hoping that by educating the bedside nurses with the evidence, they can educate other medical providers as well as parents about the importance of the neonatal HepB vaccine to help carry this improvement forward. Also, many of our bedside nurses are traveling nurses, and they work at other institutions; our hope is that they take the knowledge with them to other hospitals and apply it to future conversations.”

Park stressed that the biggest factor for success in boosting vaccination rates is multidisciplinary cooperation.

“The most difficult step was obtaining nursing leadership buy-in and support — and this was really the crucial turning point for success,” she said. – by John Schoen and Katherine Bortz

PAGE BREAK

References:

AAP Committee on Infectious Diseases; AAP Committee on Fetus and Newborn. Pediatrics. 2017;doi:10.1542/peds.2017-1870.

Pelts K, et al. 2020 Hepatitis B birth dose and timely vaccination goals: Are we there yet? Presented at: AAP National Conference & Exhibition; Oct. 25-29, 2019; New Orleans.

Park J, et al. Improving the neonatal hepatitis B vaccination rate through an interdisciplinary, multi-pronged approach. Presented at: AAP National Conference & Exhibition; Oct. 25-29, 2019; New Orleans.

Disclosures: Pelts and Park report no relevant financial disclosures.



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