User login
School-located influenza vaccination programs can be effective
School-located influenza vaccination (SLIV) increased seasonal influenza vaccination rates countywide and in both suburban and urban settings, a study found.
“Schools have a stake in influenza vaccination because immunization of schoolchildren can reduce absenteeism throughout the community. Nevertheless, only 6% of childhood influenza vaccinations occur at school. SLIV poses logistical challenges: obtaining parental consent, ordering and administering vaccine, and billing,” said Peter G. Szilagyi, MD, of Mattel Children’s Hospital, Los Angeles, and his associates.
From 2014 to 2015, 44 elementary schools were randomized in upstate New York in an organized cluster-randomized trial in which 19,776 children were eligible candidates. Seven percent of SLIV school students, 5% of suburban SLIV school students, and 9% of urban SLIV students were vaccinated at SLIV clinics. Children in SLIV schools had higher flu vaccination rates than did children in control schools countywide (54% vs. 47%, P less than .001) and in suburban (62% vs. 54%, P less than .001) and urban schools (44% vs. 39%; P less than .001).
SLIV did substitute for vaccination for urban settings serving more Vaccines for Children–covered students, but did not substitute for practice-based vaccination in the suburbs, where pediatricians often preorder influenza vaccine.
“SLIV, using Web-based consent, is a potential strategy to improve influenza vaccination coverage among large populations of children,” the researchers concluded.
Read the full story here: Pediatrics. 2016. doi: 10.1542/peds.2016-1746.
School-located influenza vaccination (SLIV) increased seasonal influenza vaccination rates countywide and in both suburban and urban settings, a study found.
“Schools have a stake in influenza vaccination because immunization of schoolchildren can reduce absenteeism throughout the community. Nevertheless, only 6% of childhood influenza vaccinations occur at school. SLIV poses logistical challenges: obtaining parental consent, ordering and administering vaccine, and billing,” said Peter G. Szilagyi, MD, of Mattel Children’s Hospital, Los Angeles, and his associates.
From 2014 to 2015, 44 elementary schools were randomized in upstate New York in an organized cluster-randomized trial in which 19,776 children were eligible candidates. Seven percent of SLIV school students, 5% of suburban SLIV school students, and 9% of urban SLIV students were vaccinated at SLIV clinics. Children in SLIV schools had higher flu vaccination rates than did children in control schools countywide (54% vs. 47%, P less than .001) and in suburban (62% vs. 54%, P less than .001) and urban schools (44% vs. 39%; P less than .001).
SLIV did substitute for vaccination for urban settings serving more Vaccines for Children–covered students, but did not substitute for practice-based vaccination in the suburbs, where pediatricians often preorder influenza vaccine.
“SLIV, using Web-based consent, is a potential strategy to improve influenza vaccination coverage among large populations of children,” the researchers concluded.
Read the full story here: Pediatrics. 2016. doi: 10.1542/peds.2016-1746.
School-located influenza vaccination (SLIV) increased seasonal influenza vaccination rates countywide and in both suburban and urban settings, a study found.
“Schools have a stake in influenza vaccination because immunization of schoolchildren can reduce absenteeism throughout the community. Nevertheless, only 6% of childhood influenza vaccinations occur at school. SLIV poses logistical challenges: obtaining parental consent, ordering and administering vaccine, and billing,” said Peter G. Szilagyi, MD, of Mattel Children’s Hospital, Los Angeles, and his associates.
From 2014 to 2015, 44 elementary schools were randomized in upstate New York in an organized cluster-randomized trial in which 19,776 children were eligible candidates. Seven percent of SLIV school students, 5% of suburban SLIV school students, and 9% of urban SLIV students were vaccinated at SLIV clinics. Children in SLIV schools had higher flu vaccination rates than did children in control schools countywide (54% vs. 47%, P less than .001) and in suburban (62% vs. 54%, P less than .001) and urban schools (44% vs. 39%; P less than .001).
SLIV did substitute for vaccination for urban settings serving more Vaccines for Children–covered students, but did not substitute for practice-based vaccination in the suburbs, where pediatricians often preorder influenza vaccine.
“SLIV, using Web-based consent, is a potential strategy to improve influenza vaccination coverage among large populations of children,” the researchers concluded.
Read the full story here: Pediatrics. 2016. doi: 10.1542/peds.2016-1746.
FROM PEDIATRICS
Another Zika vaccine heads to Phase I trials
Scientists with the U.S. Department of Defense have launched a Phase I clinical trial to test an investigational Zika vaccine that relies on inactivated virus.
The candidate vaccine is known as the Zika Purified Inactivated Virus (ZPIV) vaccine and contains whole but inactivated Zika virus particles to stimulate an immune system response without replicating and causing illness.
“We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a statement. “We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials.”
The NIAID helped support the preclinical development of the vaccine candidate and is part of a joint research agreement with the Department of Defense and other federal agencies to develop the vaccine for use in humans.
The trial at Walter Reed will enroll 75 individuals, ranging in age from 18-49 years, all of whom should have no history of a flavivirus infection. Twenty-five subjects will be given a pair of either intramuscular ZPIV injections, or a placebo (saline), with 28 days between injections.
The remaining 50 subjects will be divided into two groups of 25, with one group receiving two doses of a Japanese encephalitis virus vaccine and the other getting one dose of a yellow fever vaccine, before they both receive the two-dose ZPIV vaccine regimen.
A subgroup of 30 patients will then receive a third ZPIV dose 1 year later. Across all cohorts, the ZPIV dosage will be 5 micrograms.
In addition to the testing of the ZPIV vaccine, there are Phase I trials of a DNA-based Zika vaccine ongoing at the National Institutes of Health Clinical Center in Bethesda, Md., the Center for Vaccine Development at the University of Maryland in Baltimore, Md., and at Emory University in Atlanta, Ga. Those trials were launched in August 2016.
Scientists with the U.S. Department of Defense have launched a Phase I clinical trial to test an investigational Zika vaccine that relies on inactivated virus.
The candidate vaccine is known as the Zika Purified Inactivated Virus (ZPIV) vaccine and contains whole but inactivated Zika virus particles to stimulate an immune system response without replicating and causing illness.
“We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a statement. “We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials.”
The NIAID helped support the preclinical development of the vaccine candidate and is part of a joint research agreement with the Department of Defense and other federal agencies to develop the vaccine for use in humans.
The trial at Walter Reed will enroll 75 individuals, ranging in age from 18-49 years, all of whom should have no history of a flavivirus infection. Twenty-five subjects will be given a pair of either intramuscular ZPIV injections, or a placebo (saline), with 28 days between injections.
The remaining 50 subjects will be divided into two groups of 25, with one group receiving two doses of a Japanese encephalitis virus vaccine and the other getting one dose of a yellow fever vaccine, before they both receive the two-dose ZPIV vaccine regimen.
A subgroup of 30 patients will then receive a third ZPIV dose 1 year later. Across all cohorts, the ZPIV dosage will be 5 micrograms.
In addition to the testing of the ZPIV vaccine, there are Phase I trials of a DNA-based Zika vaccine ongoing at the National Institutes of Health Clinical Center in Bethesda, Md., the Center for Vaccine Development at the University of Maryland in Baltimore, Md., and at Emory University in Atlanta, Ga. Those trials were launched in August 2016.
Scientists with the U.S. Department of Defense have launched a Phase I clinical trial to test an investigational Zika vaccine that relies on inactivated virus.
The candidate vaccine is known as the Zika Purified Inactivated Virus (ZPIV) vaccine and contains whole but inactivated Zika virus particles to stimulate an immune system response without replicating and causing illness.
“We urgently need a safe and effective vaccine to protect people from Zika virus infection as the virus continues to spread and cause serious public health consequences, particularly for pregnant women and their babies,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said in a statement. “We are pleased to be part of the collaborative effort to advance this promising candidate vaccine into clinical trials.”
The NIAID helped support the preclinical development of the vaccine candidate and is part of a joint research agreement with the Department of Defense and other federal agencies to develop the vaccine for use in humans.
The trial at Walter Reed will enroll 75 individuals, ranging in age from 18-49 years, all of whom should have no history of a flavivirus infection. Twenty-five subjects will be given a pair of either intramuscular ZPIV injections, or a placebo (saline), with 28 days between injections.
The remaining 50 subjects will be divided into two groups of 25, with one group receiving two doses of a Japanese encephalitis virus vaccine and the other getting one dose of a yellow fever vaccine, before they both receive the two-dose ZPIV vaccine regimen.
A subgroup of 30 patients will then receive a third ZPIV dose 1 year later. Across all cohorts, the ZPIV dosage will be 5 micrograms.
In addition to the testing of the ZPIV vaccine, there are Phase I trials of a DNA-based Zika vaccine ongoing at the National Institutes of Health Clinical Center in Bethesda, Md., the Center for Vaccine Development at the University of Maryland in Baltimore, Md., and at Emory University in Atlanta, Ga. Those trials were launched in August 2016.
Low parental confidence in HPV vaccine stymies adolescent vaccination rates
More than a quarter of U.S. parents surveyed refused human papillomavirus (HPV) vaccination for their adolescents because of a lack of overall trust in adolescent vaccination programs and higher levels of perceived harm, a study found.
In an online survey of 1,484 U.S. parents, 28% of respondents reported they had refused the HPV vaccine on behalf of their children aged 11-17 years at least once. Another 8% responded they had elected to delay vaccination. The remaining two-thirds of respondents said they had neither refused nor delayed the vaccination, reported Melissa B. Gilkey, PhD, of Harvard Medical School, Boston, and her associates (Hum Vaccin Immunother. 2016. doi: 10.1080/21645515.2016.1247134).
Compared with parents who reported neither refusal nor delay, refusal was associated with lower confidence in adolescent vaccination (relative risk ratio = 0.66, 95% CI, 0.48-0.91), lower perceived HPV vaccine effectiveness (RRR = 0.68, 95% CI, 0.50-0.91), and higher perceived harms (RRR = 3.49, 95% CI, 2.65-4.60). Parents who reported delaying vaccination were more likely to endorse insufficient information as the reason (RRR = 1.76, 95% CI, 1.08-2.85). While 79% of parents who had delayed HPV vaccination said talking with a physician would help them with their decision, 61% of parents who refused the vaccination said it would. In addition, nearly half of parents who delayed vaccination said they did so out of a preference to wait until their children were older.
In adolescents whose parents had ever refused the vaccine, only 27% had received one HPV vaccine vs. 59% in those whose parents had elected to delay vaccination. Among adolescents whose parents responded they had neither refused nor delayed the vaccine, 56% had received one HPV vaccine.
Although the investigators did not find race, ethnicity, nor educational attainment were drivers of whether a parent chose to vaccinate, families with higher income levels tended to refuse the HPV vaccine more often than did other parents (RRR: 1.48, 95% confidence interval, 1.02-2.15).
Merck and the National Cancer Institute funded the study. Coauthor Noel T. Brewer, PhD, has received HPV vaccine-related grants from, or been on paid advisory boards for, Merck, GlaxoSmithKline, and Pfizer; he served on the National Vaccine Advisory Committee Working Group on HPV Vaccine and is chair of the National HPV Vaccination Roundtable.
More than a quarter of U.S. parents surveyed refused human papillomavirus (HPV) vaccination for their adolescents because of a lack of overall trust in adolescent vaccination programs and higher levels of perceived harm, a study found.
In an online survey of 1,484 U.S. parents, 28% of respondents reported they had refused the HPV vaccine on behalf of their children aged 11-17 years at least once. Another 8% responded they had elected to delay vaccination. The remaining two-thirds of respondents said they had neither refused nor delayed the vaccination, reported Melissa B. Gilkey, PhD, of Harvard Medical School, Boston, and her associates (Hum Vaccin Immunother. 2016. doi: 10.1080/21645515.2016.1247134).
Compared with parents who reported neither refusal nor delay, refusal was associated with lower confidence in adolescent vaccination (relative risk ratio = 0.66, 95% CI, 0.48-0.91), lower perceived HPV vaccine effectiveness (RRR = 0.68, 95% CI, 0.50-0.91), and higher perceived harms (RRR = 3.49, 95% CI, 2.65-4.60). Parents who reported delaying vaccination were more likely to endorse insufficient information as the reason (RRR = 1.76, 95% CI, 1.08-2.85). While 79% of parents who had delayed HPV vaccination said talking with a physician would help them with their decision, 61% of parents who refused the vaccination said it would. In addition, nearly half of parents who delayed vaccination said they did so out of a preference to wait until their children were older.
In adolescents whose parents had ever refused the vaccine, only 27% had received one HPV vaccine vs. 59% in those whose parents had elected to delay vaccination. Among adolescents whose parents responded they had neither refused nor delayed the vaccine, 56% had received one HPV vaccine.
Although the investigators did not find race, ethnicity, nor educational attainment were drivers of whether a parent chose to vaccinate, families with higher income levels tended to refuse the HPV vaccine more often than did other parents (RRR: 1.48, 95% confidence interval, 1.02-2.15).
Merck and the National Cancer Institute funded the study. Coauthor Noel T. Brewer, PhD, has received HPV vaccine-related grants from, or been on paid advisory boards for, Merck, GlaxoSmithKline, and Pfizer; he served on the National Vaccine Advisory Committee Working Group on HPV Vaccine and is chair of the National HPV Vaccination Roundtable.
More than a quarter of U.S. parents surveyed refused human papillomavirus (HPV) vaccination for their adolescents because of a lack of overall trust in adolescent vaccination programs and higher levels of perceived harm, a study found.
In an online survey of 1,484 U.S. parents, 28% of respondents reported they had refused the HPV vaccine on behalf of their children aged 11-17 years at least once. Another 8% responded they had elected to delay vaccination. The remaining two-thirds of respondents said they had neither refused nor delayed the vaccination, reported Melissa B. Gilkey, PhD, of Harvard Medical School, Boston, and her associates (Hum Vaccin Immunother. 2016. doi: 10.1080/21645515.2016.1247134).
Compared with parents who reported neither refusal nor delay, refusal was associated with lower confidence in adolescent vaccination (relative risk ratio = 0.66, 95% CI, 0.48-0.91), lower perceived HPV vaccine effectiveness (RRR = 0.68, 95% CI, 0.50-0.91), and higher perceived harms (RRR = 3.49, 95% CI, 2.65-4.60). Parents who reported delaying vaccination were more likely to endorse insufficient information as the reason (RRR = 1.76, 95% CI, 1.08-2.85). While 79% of parents who had delayed HPV vaccination said talking with a physician would help them with their decision, 61% of parents who refused the vaccination said it would. In addition, nearly half of parents who delayed vaccination said they did so out of a preference to wait until their children were older.
In adolescents whose parents had ever refused the vaccine, only 27% had received one HPV vaccine vs. 59% in those whose parents had elected to delay vaccination. Among adolescents whose parents responded they had neither refused nor delayed the vaccine, 56% had received one HPV vaccine.
Although the investigators did not find race, ethnicity, nor educational attainment were drivers of whether a parent chose to vaccinate, families with higher income levels tended to refuse the HPV vaccine more often than did other parents (RRR: 1.48, 95% confidence interval, 1.02-2.15).
Merck and the National Cancer Institute funded the study. Coauthor Noel T. Brewer, PhD, has received HPV vaccine-related grants from, or been on paid advisory boards for, Merck, GlaxoSmithKline, and Pfizer; he served on the National Vaccine Advisory Committee Working Group on HPV Vaccine and is chair of the National HPV Vaccination Roundtable.
Key clinical point:
Major finding: HPV vaccine refusal rate was 28% in parents of teens and preteens; the rate of vaccine delay was 8%.
Data source: Online survey conducted in 2014-2015 of 1,484 U.S. parents with children between ages of 11 and 17 years.
Disclosures: Merck and the National Cancer Institute funded the study. Coauthor Noel T. Brewer, PhD, has received HPV vaccine-related grants from, or been on paid advisory boards for, Merck, GlaxoSmithKline, and Pfizer; he served on the National Vaccine Advisory Committee Working Group on HPV Vaccine and is chair of the National HPV Vaccination Roundtable.
Yes, pediatric practices can provide immunizations without going broke
SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.
He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.
His company has collected data suggesting that as of 2015, revenue from vaccine products made up fully 21% of all revenue in private pediatric practices, a near doubling from the value in 2003. As a consultant today, “I try to find out how practices manage the vaccines because, after staff, it’s your biggest expense,” he noted.
Spotting hidden costs
In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.
What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.
They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.
Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.
“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.
Doing the math
Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.
They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.
Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.
Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.
Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.
Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).
“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”
Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”
Striving for profitability
“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”
Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”
Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.
“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”
Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.
“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.
Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.
“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.
Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.
Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.
pdnews@frontlinemedcom.com
SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.
He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.
His company has collected data suggesting that as of 2015, revenue from vaccine products made up fully 21% of all revenue in private pediatric practices, a near doubling from the value in 2003. As a consultant today, “I try to find out how practices manage the vaccines because, after staff, it’s your biggest expense,” he noted.
Spotting hidden costs
In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.
What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.
They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.
Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.
“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.
Doing the math
Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.
They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.
Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.
Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.
Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.
Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).
“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”
Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”
Striving for profitability
“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”
Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”
Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.
“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”
Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.
“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.
Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.
“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.
Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.
Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.
pdnews@frontlinemedcom.com
SAN FRANCISCO – With a little number crunching and strategizing, pediatric practices can provide immunizations to their patients without getting financially soaked, according to Chip Hart, a pediatric practice management consultant.
He discussed various pitfalls and challenges when it comes to the business aspects of providing immunizations, and offered some solutions at the annual meeting of the American Academy of Pediatrics.
His company has collected data suggesting that as of 2015, revenue from vaccine products made up fully 21% of all revenue in private pediatric practices, a near doubling from the value in 2003. As a consultant today, “I try to find out how practices manage the vaccines because, after staff, it’s your biggest expense,” he noted.
Spotting hidden costs
In its business case, the AAP determined that direct and indirect expenses for vaccine product total to 17% to 28% of the cost. In other words, “if you buy a vaccine for $100, you need to collect somewhere between $117 and $128, on average, just to break even,” Mr. Hart explained.
What accounts for that extra expense? Carrying costs that are commonly overlooked, namely, those myriad costs of providing immunizations that accrue before a child is given any vaccine and that can add up quickly.
They include the costs of the refrigerator and examination table; the sharps and waste management; insurance to cover vaccine loss; vaccine wastage and denials; and opportunity cost, that is, the cost of not being able to invest the funds tied up in vaccine sitting in the fridge – some $75,000 to $100,000 for the average practice – elsewhere.
Add to those personnel costs; costs related to activities such as ordering, inventory and storage management, registry input, and temperature monitoring; and malpractice coverage. And not to be forgotten is the inability to collect payment for some vaccines.
“You’re not paid for carrying costs. Unfortunately, society or the American health care system has given pediatricians this burden,” Mr. Hart commented.
Doing the math
Pediatricians can get a handle on the true costs to their practice of providing immunizations by spending just an hour or two crunching some key numbers, according to Mr. Hart.
They should start by ascertaining those carrying costs. For example, assuming hazardous waste costs run $3,500 per year, vaccines account for 50% of the waste, and the practice gives 13,000 vaccines annually, it averages out to $0.13 per vaccine.
Similar calculations are done to determine the costs of administering the shot (preparing, administering, counseling, billing, recording, putting it in the registry, and so on), arriving at about $12 per vaccine. The largest share here comes from clinicians, so calculations focus on their hourly wages and the percent of their time spent on vaccines.
Next is a calculation of the cost of the vaccine product. This calculation starts with the hypothetical invoiced amount of $100, factors in units that are wasted or go unpaid (at least 5%, according to AAP data), and tacks on the distributed carrying costs, arriving finally at an actual cost to the practice of about $120.
Last, all of these data are loaded into a payer-specific spreadsheet. Commonly, payers go by Red Book values and will therefore cover, for example, only $98 of that $100 invoice cost of the vaccine. But they will pay roughly $27 for its administration.
Taken together, the math suggests the practice bears a total cost of $132 for this vaccine ($120 for the product and $12 for its administration) but will collect only $125 from this payer ($98 for the product and $27 for its administration).
“You see over and over again that the payers underpay for the vaccines and pay you well for the administration, and it very often makes up the difference,” Mr. Hart noted. “But even with that boost on the admin side, this practice is losing money on this vaccine – they get $125 for something that costs them $132.”
Practices strapped for time can use some estimates in their spreadsheets instead, he said. “If you use an assumption of 25% over your invoice” – roughly the midpoint between the AAP’s 17% and 28% – “and $12 to $15 on your administration” – based on the value found in a study using time-motion analysis (Pediatrics. 2009 Dec;124 Suppl 5:S492-8) – “for your costs, all you need is your fee schedule, and you can make a spreadsheet to find out whether it makes sense to continue giving immunizations to this payer’s kids.”
Striving for profitability
“In all honesty, from what I see nationally, pediatricians break even on vaccines. It’s a break-even situation, on average,” Mr. Hart commented. “But who wants to be average? No one. We want you to actually be profitable with vaccines because it’s the only way you can continue to give them.”
Practices can take a variety of steps toward that goal. First, they should negotiate payments with payers, using the AAP’s business case and other literature. “Don’t listen to anybody” who says you can’t negotiate, he stressed. “You can negotiate. I don’t care if you’re a solo practice or you’ve just opened. If a payer says they can’t negotiate, they are fibbing to you. The only payers who don’t negotiate are the state Medicaid and Medicare. Everyone else can and does.”
Second, practices should ensure that they are using proper Current Procedural Terminology codes when submitting claims to payers to maximize payment.
“I still see too many practices who don’t bill for these properly,” Mr. Hart commented. “If you have a typical pediatric practice and you use more 90471s and 90472s than 90460s and 90461s, and frankly, if [the latter] aren’t two to three to four to five times more common… you are losing a lot of money.”
Third, practices should join or confirm that they belong to an effective group purchasing organization (GPO) to reduce their vaccine costs, with data suggesting that doing so will save the practice $10,000 to $15,000 per physician each year.
“If you are solo, out on the furthest edge of Alaska, you can see Russia from your house, and you have no leverage whatsoever, you can sign up with one of these GPOs and you are as strong as any hospital,” he said. The AAP helps here as well, by maintaining a list of GPOs on its website.
Fourth, practices should review their vaccine delivery work flow to look for money leaks, Mr. Hart advised. For example, physicians who get caught up in tasks such as ordering and inventorying are losing revenue that could come in from seeing patients.
“This is the sort of thing that affects your bottom line substantially. And it’s exactly the sort of thing that is an invisible expense: the business owners don’t consider their time as part of the expense of doing this administration,” he said.
Additionally, legacy procedures should be re-evaluated to see if they can be streamlined. Gains also may be made here from investing in better technology, such as a refrigerator with a glass door that saves time by allowing ready identification of vaccines.
Finally, practices should join the AAP’s Section on Administration and Practice Management (SOAPM) as it’s an invaluable, interactive resource in this area when questions or challenges arise, Mr. Hart recommended.
pdnews@frontlinemedcom.com
AT AAP 16
Study finds no increase in microcephaly with Tdap vaccine in pregnancy
The combined tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is not associated with an increased risk of microcephaly and other structural birth defects when administered during pregnancy, according to findings from a large, retrospective cohort study.
The U.S. Advisory Committee on Immunization Practices currently recommends administration of the Tdap vaccine between 27 and 36 weeks’ gestation in every pregnancy. However, the overlap of the start of Brazil’s maternal Tdap immunization in November 2014 with the substantial increase in microcephaly cases in 2015 prompted concerns of an association between the vaccine and structural birth defects.
They found that Tdap immunization was not significantly associated with an increased risk for microcephaly during any week of pregnancy (adjusted prevalence ratio, 0.86; 95% CI, 0.60-1.24). They also saw no increased risk of microcephaly when vaccinations occurred before 14 weeks’ gestation (adjusted prevalence ratio, 0.96; 95% CI, 0.36-2.58), or when vaccinations were administered between 27 weeks’ and 36 weeks’ gestation (adjusted prevalence ratio, 1.01; 95% CI, 0.63-1.61). The findings were similar for other structural defects, including congenital heart defects, spina bifida, encephalocele, and anophthalmia (JAMA. 2016;316[17]:1823-5).
“These results expand upon what is known about maternal Tdap vaccination safety to include information about structural birth defects and microcephaly in offspring,” the investigators wrote. “The findings support recommendations for routine Tdap administration during pregnancy.”
However, they noted that the study findings may have been limited by incomplete data on women’s immunization status, birth defects, and defects that may have resulted in pregnancy loss or elective termination.
The study was funded by the Centers for Disease Control and Prevention. The investigators reported having no relevant financial disclosures.
The combined tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is not associated with an increased risk of microcephaly and other structural birth defects when administered during pregnancy, according to findings from a large, retrospective cohort study.
The U.S. Advisory Committee on Immunization Practices currently recommends administration of the Tdap vaccine between 27 and 36 weeks’ gestation in every pregnancy. However, the overlap of the start of Brazil’s maternal Tdap immunization in November 2014 with the substantial increase in microcephaly cases in 2015 prompted concerns of an association between the vaccine and structural birth defects.
They found that Tdap immunization was not significantly associated with an increased risk for microcephaly during any week of pregnancy (adjusted prevalence ratio, 0.86; 95% CI, 0.60-1.24). They also saw no increased risk of microcephaly when vaccinations occurred before 14 weeks’ gestation (adjusted prevalence ratio, 0.96; 95% CI, 0.36-2.58), or when vaccinations were administered between 27 weeks’ and 36 weeks’ gestation (adjusted prevalence ratio, 1.01; 95% CI, 0.63-1.61). The findings were similar for other structural defects, including congenital heart defects, spina bifida, encephalocele, and anophthalmia (JAMA. 2016;316[17]:1823-5).
“These results expand upon what is known about maternal Tdap vaccination safety to include information about structural birth defects and microcephaly in offspring,” the investigators wrote. “The findings support recommendations for routine Tdap administration during pregnancy.”
However, they noted that the study findings may have been limited by incomplete data on women’s immunization status, birth defects, and defects that may have resulted in pregnancy loss or elective termination.
The study was funded by the Centers for Disease Control and Prevention. The investigators reported having no relevant financial disclosures.
The combined tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is not associated with an increased risk of microcephaly and other structural birth defects when administered during pregnancy, according to findings from a large, retrospective cohort study.
The U.S. Advisory Committee on Immunization Practices currently recommends administration of the Tdap vaccine between 27 and 36 weeks’ gestation in every pregnancy. However, the overlap of the start of Brazil’s maternal Tdap immunization in November 2014 with the substantial increase in microcephaly cases in 2015 prompted concerns of an association between the vaccine and structural birth defects.
They found that Tdap immunization was not significantly associated with an increased risk for microcephaly during any week of pregnancy (adjusted prevalence ratio, 0.86; 95% CI, 0.60-1.24). They also saw no increased risk of microcephaly when vaccinations occurred before 14 weeks’ gestation (adjusted prevalence ratio, 0.96; 95% CI, 0.36-2.58), or when vaccinations were administered between 27 weeks’ and 36 weeks’ gestation (adjusted prevalence ratio, 1.01; 95% CI, 0.63-1.61). The findings were similar for other structural defects, including congenital heart defects, spina bifida, encephalocele, and anophthalmia (JAMA. 2016;316[17]:1823-5).
“These results expand upon what is known about maternal Tdap vaccination safety to include information about structural birth defects and microcephaly in offspring,” the investigators wrote. “The findings support recommendations for routine Tdap administration during pregnancy.”
However, they noted that the study findings may have been limited by incomplete data on women’s immunization status, birth defects, and defects that may have resulted in pregnancy loss or elective termination.
The study was funded by the Centers for Disease Control and Prevention. The investigators reported having no relevant financial disclosures.
FROM JAMA
Key clinical point:
Major finding: Tdap immunization was not significantly associated with an increased risk for microcephaly during any week of pregnancy (adjusted prevalence ratio, 0.86; 95% CI, 0.60-1.24).
Data source: A retrospective cohort study in 41,654 singleton infants born to women who received Tdap during pregnancy and a control group of 282,809 babies born to unvaccinated women.
Disclosures: The study was funded by the Centers for Disease Control and Prevention. The investigators reported having no relevant financial disclosures.
Fatal measles complication occurs more often than realized
NEW ORLEANS – A fatal complication of measles known as subacute sclerosing panencephalitis (SSPE) can develop years after measles infection and appears to occur much more often than published reports suggest, according to a review of cases in California from 1998 to 2015.
The findings underscore the vital importance of herd immunity by vaccination, Kristen Wendorf, MD, reported at an annual scientific meeting on infectious diseases.
The incidence of postmeasles SSPE was previously thought be about 1 in 100,000, according to an IDWeek press release.
“There is no cure for SSPE, and the only way to prevent it is to vaccinate everyone against measles,” the release stated.
The cases in the current study were among children with a clinically compatible illness, and either measles IgG antibody detected in cerebrospinal fluid, a characteristic pattern on electroencephalography, typical histologic findings on brain biopsy, or medical record documentation of SSPE-related complications. They were identified based on death certificates, reports from the Centers for Diseases Control and Prevention, or through investigations for undiagnosed neurologic disease. Twelve of the 17 affected children had a clinical history of a febrile rash illness compatible with measles, and all 12 of those experienced illness before age 15 months and before measles vaccination.
Most (67%) were living in the United States when they had measles, Dr. Wendorf said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The median age at diagnosis of SSPE was 12 years, although the range was 3-35 years, and the mean latency period was 9.5 years. In many cases, long-standing cognitive or motor problems were experienced prior to diagnosis, she noted.
The findings suggest that SSPE is more common than previously recognized in unvaccinated children with measles during infancy, Dr. Wendorf said.
Protection of infants younger than 12-15 months of age – before the time when measles vaccine is routinely administered – and in those who can’t be vaccinated because of immune system disorders requires avoidance of travel to endemic areas. Parents also may consider early vaccination prior to such travel.
Further, clinicians should be aware of the risk of SSPE in patients with symptoms suggestive of the disease. This is true even among older patients in whom no specific history of measles infection is known, she said.
In the press release, coauthor James D. Cherry, MD, professor of pediatrics at the University of California, Los Angeles, further stressed the importance of protecting unvaccinated infants.
“Parents of infants who have not yet been vaccinated should avoid putting their children at risk. For example, they should postpone trips overseas – including to Europe – where measles is endemic and epidemic until after their baby has been vaccinated with two doses,” he said. “It’s just not worth the risk.”
The authors reported having no disclosures.
NEW ORLEANS – A fatal complication of measles known as subacute sclerosing panencephalitis (SSPE) can develop years after measles infection and appears to occur much more often than published reports suggest, according to a review of cases in California from 1998 to 2015.
The findings underscore the vital importance of herd immunity by vaccination, Kristen Wendorf, MD, reported at an annual scientific meeting on infectious diseases.
The incidence of postmeasles SSPE was previously thought be about 1 in 100,000, according to an IDWeek press release.
“There is no cure for SSPE, and the only way to prevent it is to vaccinate everyone against measles,” the release stated.
The cases in the current study were among children with a clinically compatible illness, and either measles IgG antibody detected in cerebrospinal fluid, a characteristic pattern on electroencephalography, typical histologic findings on brain biopsy, or medical record documentation of SSPE-related complications. They were identified based on death certificates, reports from the Centers for Diseases Control and Prevention, or through investigations for undiagnosed neurologic disease. Twelve of the 17 affected children had a clinical history of a febrile rash illness compatible with measles, and all 12 of those experienced illness before age 15 months and before measles vaccination.
Most (67%) were living in the United States when they had measles, Dr. Wendorf said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The median age at diagnosis of SSPE was 12 years, although the range was 3-35 years, and the mean latency period was 9.5 years. In many cases, long-standing cognitive or motor problems were experienced prior to diagnosis, she noted.
The findings suggest that SSPE is more common than previously recognized in unvaccinated children with measles during infancy, Dr. Wendorf said.
Protection of infants younger than 12-15 months of age – before the time when measles vaccine is routinely administered – and in those who can’t be vaccinated because of immune system disorders requires avoidance of travel to endemic areas. Parents also may consider early vaccination prior to such travel.
Further, clinicians should be aware of the risk of SSPE in patients with symptoms suggestive of the disease. This is true even among older patients in whom no specific history of measles infection is known, she said.
In the press release, coauthor James D. Cherry, MD, professor of pediatrics at the University of California, Los Angeles, further stressed the importance of protecting unvaccinated infants.
“Parents of infants who have not yet been vaccinated should avoid putting their children at risk. For example, they should postpone trips overseas – including to Europe – where measles is endemic and epidemic until after their baby has been vaccinated with two doses,” he said. “It’s just not worth the risk.”
The authors reported having no disclosures.
NEW ORLEANS – A fatal complication of measles known as subacute sclerosing panencephalitis (SSPE) can develop years after measles infection and appears to occur much more often than published reports suggest, according to a review of cases in California from 1998 to 2015.
The findings underscore the vital importance of herd immunity by vaccination, Kristen Wendorf, MD, reported at an annual scientific meeting on infectious diseases.
The incidence of postmeasles SSPE was previously thought be about 1 in 100,000, according to an IDWeek press release.
“There is no cure for SSPE, and the only way to prevent it is to vaccinate everyone against measles,” the release stated.
The cases in the current study were among children with a clinically compatible illness, and either measles IgG antibody detected in cerebrospinal fluid, a characteristic pattern on electroencephalography, typical histologic findings on brain biopsy, or medical record documentation of SSPE-related complications. They were identified based on death certificates, reports from the Centers for Diseases Control and Prevention, or through investigations for undiagnosed neurologic disease. Twelve of the 17 affected children had a clinical history of a febrile rash illness compatible with measles, and all 12 of those experienced illness before age 15 months and before measles vaccination.
Most (67%) were living in the United States when they had measles, Dr. Wendorf said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The median age at diagnosis of SSPE was 12 years, although the range was 3-35 years, and the mean latency period was 9.5 years. In many cases, long-standing cognitive or motor problems were experienced prior to diagnosis, she noted.
The findings suggest that SSPE is more common than previously recognized in unvaccinated children with measles during infancy, Dr. Wendorf said.
Protection of infants younger than 12-15 months of age – before the time when measles vaccine is routinely administered – and in those who can’t be vaccinated because of immune system disorders requires avoidance of travel to endemic areas. Parents also may consider early vaccination prior to such travel.
Further, clinicians should be aware of the risk of SSPE in patients with symptoms suggestive of the disease. This is true even among older patients in whom no specific history of measles infection is known, she said.
In the press release, coauthor James D. Cherry, MD, professor of pediatrics at the University of California, Los Angeles, further stressed the importance of protecting unvaccinated infants.
“Parents of infants who have not yet been vaccinated should avoid putting their children at risk. For example, they should postpone trips overseas – including to Europe – where measles is endemic and epidemic until after their baby has been vaccinated with two doses,” he said. “It’s just not worth the risk.”
The authors reported having no disclosures.
AT IDWEEK 2016
Key clinical point:
Major finding: The incidence of SSPE among measles cases was 1 in 1,367 children under age 5 years and 1 in 609 children under age 12 months at the time of measles disease.
Data source: A review of records and 17 cases of SSPE.
Disclosures: The authors reported having no disclosures.
Influenza: Still more important than Zika virus
The mass media and the medical literature have been saturated in the last few years by concerns about a variety of emerging viral epidemics such as Ebola and Zika. We must always remember that influenza will continue to affect many more patients worldwide.
The Cleveland Clinic Journal of Medicine periodically publishes updates on influenza, a topic befitting the large proportion of internists and internal medicine subspecialists who regularly read the Journal. This series began in 1975 with an article by Steven R. Mostow, MD,1 which followed three pandemics that changed the world’s attitude about influenza.
A lot has changed since then, including another pandemic in 2009–2010. Here, I review recent information relevant to daily practice.
NO REASON FOR COMPLACENCY
The relatively mild 2015–2016 influenza season is no reason for complacency this season.
Influenza activity in 2015–2016 was milder than in most seasons in the last decade.2 Activity peaked in mid-March and resulted in fewer outpatient visits, hospitalizations, and deaths than in previous seasons. Influenza A (H1N1)pdm09 has remained the predominant circulating virus since 2009. Although the overall rate of influenza-related hospitalization was less than half that in previous years, the hospitalization rate of middle-aged adults was relatively high (16.8 per 100,000 population). Importantly, 92% of adults with influenza illness that required hospitalization had at least one underlying medical condition, alerting us as healthcare providers that there is plenty of room for improvement in preventing such hospitalizations.
We should remain vigilant. We should put forth our best efforts in vaccinating all individuals above the age of 6 months and in diagnosing influenza early in the course of the illness in order to prescribe antiviral therapy within 48 hours of onset of symptoms. These actions not only shorten the illness and prevent hospitalization and secondary bacterial infection, but also reduce contagion and thus reduce overall healthcare costs.
School closure as a measure to halt epidemics has been lately called into question,3 since there are not enough data to support doing this routinely. School closure in Western Kentucky during the 2013 influenza epidemic did not reduce transmission but caused additional economic and social difficulties for certain households.4
STUDIES REINFORCE EARLIER DATA THAT INFLUENZA VACCINE WORKS
In the several decades since influenza vaccine became available, hundreds of studies have demonstrated the value of the “flu shot.” A few recent papers that support these well-established data:
- In adults who sought medical care for acute respiratory illness, influenza vaccine was 58.4% effective in preventing laboratory-confirmed influenza illness in adults age 50 and older.5
- In the same age group, influenza vaccine was 56.8% effective in preventing laboratory-confirmed influenza hospitalizations.6
- Influenza vaccination in patients with heart failure reduced all-cause hospitalizations, particularly cardiovascular hospitalizations (30% reduction) and hospitalizations for respiratory infections (16% reduction).7 This effect lasted up to 4 months after influenza vaccination.
- Patients who were hospitalized with community-acquired, laboratory-confirmed influenza pneumonia were 43% less likely to have received the influenza vaccine than patients hospitalized with community-acquired pneumonia due to other pathogens.8
INFLUENZA VACCINE IS EVEN MORE VALUABLE DURING PREGNANCY
Influenza vaccination during pregnancy prevented one in five preterm deliveries in a developing country9 and reduced the risk of stillbirth by 50% in Australia.10
An interesting collateral benefit was demonstrated in a survey conducted in Minnesota, where children of mothers who self-reported prenatal influenza vaccination were more likely to complete their routine childhood vaccination series.11
ADDITIONAL BENEFITS OF INFLUENZA VACCINATION
A recently appreciated benefit is that influenza vaccine induces cross-reactive protective immune responses (“heterologous immunity”) to viral strains not included in the vaccine, even in immunosuppressed individuals such as kidney transplant recipients.12 Interestingly, patients were more likely to seroconvert for a cross-reactive “heterologous” antigen if they also seroconverted for the vaccine-specific “homologous” antigen.
In a study in mice, an influenza vaccine with an adjuvant protected mice not only from influenza virus challenge, but also from a Staphylococcus aureus superinfection challenge.13 This novel idea suggests that influenza vaccine protects not only against influenza virus infection, but also against a potentially fatal secondary bacterial infection. This has significant implications for curbing antibacterial use, with an expected reduction in antimicrobial resistance.
Another important benefit of influenza vaccination was recently demonstrated when ferrets were intranasally inoculated with the highly pathogenic influenza A(H5N1) strain and then received either influenza vaccine or prophylactic oseltamivir. Ferrets that received the vaccine were less likely to develop severe meningoencephalitis.14 Since influenza A(H5N1) is much more virulent than the current circulating influenza strains, and since it may be the cause of the next pandemic, preventing such a serious complication of influenza would be lifesaving.
SAFETY OF INFLUENZA VACCINATION
Hundreds of studies involving thousands of people have established the safety of influenza vaccination.
Issues related to Guillain-Barré syndrome have long been put to rest. A large retrospective study found no evidence of increased risk of Guillain-Barré syndrome following vaccination of any kind, including influenza vaccination.15
Local reactions after vaccination are transient and do not interfere with the ability to perform daily activities.
In this era of utilization review, it is reassuring to know that giving influenza vaccine to hospitalized surgical patients was not associated with an increased rate of postdischarge fever or other clinical concern for infection requiring emergency room visits or rehospitalization.16
WHY INFLUENZA VACCINE MAY NOT PREVENT ALL CASES OF INFLUENZA
Whether neutralizing antibodies to influenza virus hemagglutinin antigen should be the main immune correlate of protection for influenza vaccines remains in question. Although prepandemic avian influenza vaccines are poorly immunogenic in inducing neutralizing antibodies, they confer considerable protection. A recent study showed that antibody-dependent cell-mediated cytotoxicity to hemagglutinin antigen in an avian influenza vaccine was a better predictor of protective capacity than neutralizing antibodies.17
Patterns of immunity induced by the live-attenuated influenza vaccine and the inactivated influenza vaccine are different.18 In fact, no single cytokine or chemokine measurement predicts protection.
Even though adults age 50 and older mount statistically significant humoral and cell-mediated immune responses to the inactivated vaccine, two-thirds do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H1N1), and one-fifth do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H3N2).19 While age had some negative effect on vaccine responsiveness, prevaccination titers were much better at predicting postvaccination antibody levels.
ONGOING DEBATE OVER LIVE-ATTENUATED INFLUENZA VACCINE
Several studies had shown that the live-attenuated influenza vaccine, given intranasally, was not only more protective in vaccinated children, but also provided herd protection in unvaccinated contacts. However, a recently published study conducted in Canadian Hutterite children showed that the live-attenuated vaccine did not result in herd immunity when compared to the inactivated influenza vaccine.20
On June 22, 2016, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended against the use of the live-attenuated vaccine for the 2016–2017 season,21 based on data showing negligible protection conferred by the live-attenuated influenza vaccine in the three preceding influenza seasons.
This decision created significant debate among experts in the field. It is unclear why the live-attenuated influenza vaccine was much less protective in the last three seasons than in prior seasons. Recommending against its use in the United States will essentially eliminate any possibility of reassessing its efficacy in this country. Of note, the quadrivalent live-attenuated influenza vaccine had recently replaced the previous trivalent live-attenuated vaccine, which may have introduced some “competition” among the vaccine strains to infect enough cells to allow viral replication and subsequent immune response. Another potential explanation is that consistent annual vaccination may have resulted in a cumulative immunity that could hamper response to subsequent doses.
COMPOSITION OF THE 2016–2017 INFLUENZA VACCINE
The 2016–2017 quadrivalent inactivated influenza vaccine will contain22:
- A/California/7/2009 (H1N1)pdm09-like virus
- A/Hong Kong/4801/2014 (H3N2)-like virus
- B/Brisbane/60/2008-like virus (B/Victoria lineage)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage).
This represents a change in the A (H3N2) component compared with the 2015–2016 vaccine.
Influenza vaccine manufacturers estimated they would produce 170 million doses for distribution in the United States for the upcoming influenza season. The previously mentioned recommendation against the use of the live-attenuated vaccine, which accounts for approximately 8% of the influenza vaccine supply, may affect vaccine uptake, particularly in children.
NEW ANTI-INFLUENZA AGENTS AND UPDATE ON EXISTING AGENTS
Neuraminidase inhibitors are the only class of antiviral drugs currently recommended for prevention and treatment of influenza. The three products currently available in the United States are oseltamivir, zanamivir, and peramivir. Oseltamivir is administered orally, and the first generic version was approved by the US Food and Drug Administration on August 3, 2016. Zanamivir is administered by oral inhalation. Both oseltamivir and zanamivir are approved for treatment and prevention of influenza. Peramivir is administered intravenously as a single dose and is approved only for the treatment of acute influenza, not prevention.
Unfortunately, the influenza vaccination rate during pregnancy in the United States remains only around 50%.23 Physicians’ recommendations are strongly associated with vaccine uptake, particularly when they emphasize protective effect on the newborn. Influenza during pregnancy carries higher mortality than in the general population, with collateral fetal loss.
Early initiation of antiviral therapy is particularly imperative during pregnancy. A recent study showed that starting antiviral therapy within 2 days of onset of illness in pregnant women hospitalized with severe influenza reduced length of stay by 5.6 days compared with those in whom therapy was started more than 2 days after illness onset.24
A single dose of laninamivir octanoate, a long-acting neuraminidase inhibitor currently approved in Japan for treating influenza, was recently shown to be effective as postexposure prophylaxis.25 This option may be convenient for people who prefer not to take a daily medication for several days, or in an outbreak in a healthcare facility.
- Mostow SR. Current perspectives of influenza. Cleve Clin J Med 1975; 42:63–70.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity — United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Sasaki A, Hoen AG, Al Ozonoff A, et al. Evidence-based tool for triggering school closures during influenza outbreaks, Japan. Emerg Infect Dis 2009; 15:1841–1843.
- Russell ES, Zheteyeva Y, Gao H, et al. Reactive school closure during increased influenza-like Illness (ILI) activity in Western Kentucky, 2013: a field evaluation of effect on ILI incidence and economic and social consequences for families. Open Forum Infect Dis (Summer 2016) 3 (3): first published online May 25, 2016. doi:10.1093/ofid/ofw113.
- Chen Q, Griffin MR, Nian H, et al. Influenza vaccine prevents medically attended influenza-associated acute respiratory illness in adults aged ≥ 50 years. J Infect Dis 2015, 211:1045–1050.
- Havers FP, Sokolow L, Shay DK, et al. Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010–11. Clin Infect Dis 2016. [Epub ahead of print.].
- Influenza vaccination linked to fewer CV, respiratory hospitalizations in patients with HF. Helio Cardiology Today, May 25, 2016. www.healio.com/cardiology/hf-transplantation/news/online/%7B5292db4f-fc81-43f2-a28d-c124f2a6331b%7D/influenza-vaccination-linked-to-fewer-cv-respiratory-hospitalizations-in-patients-with-hf. Accessed October 6, 2016.
- Grijalva CG, Zhu Y, Williams DJ, et al. Association between hospitalization with community-acquired laboratory-confirmed influenza pneumonia and prior receipt of influenza vaccination. JAMA 2015, 314:1488–1497.
- Olsen SJ, Mirza SA, Vonglokham P, et al. The effect of influenza vaccination on birth outcomes in a cohort of pregnant women in Lao PDR, 2014–2015. Clin Infect Dis 2016; 63:487–494.
- Regan AK, Moore HC, de Klerk N, et al. Seasonal trivalent influenza vaccination during pregnancy and the incidence of stillbirth: population-based retrospective cohort study. Clin Infect Dis 2016; 62:1221–1227.
- Fuchs EL. Self-reported prenatal influenza vaccination and early childhood vaccine series completion. Prev Med 2016; 88:8–12.
- Kumar D, Ferreira VH, Campbell P, Hoschler K, Humar A. Heterologous immune responses to influenza vaccine in kidney transplant recipients. Am J Transplant 2016; accepted manuscript online: 12 Jul 2016; doi: 10.1111/ajt.13960. [Epub ahead of print.]
- Zurli V, Gallotta M, Taccone M, et al. Positive contribution of adjuvanted influenza vaccines to the resolution of bacterial superinfections. J Infect Dis 2016; 213:1876–1885.
- Siegers JY, van den Brand JM, Leijten LM, et al. Vaccination is more effective than prophylactic oseltamivir in preventing CNS invasion by H5N1 virus via the olfactory nerve. J Infect Dis 2016; 214:516–524.
- Baxter R, Bakshi N, Fireman B, et al. Lack of association of Guillain-Barré syndrome with vaccinations. Clin Infect Dis 2013; 57:197–204.
- Tartof SY, Qian L, Rieg G, et al. Safety of seasonal Influenza vaccination in hospitalized surgical patients: a cohort study. Ann Intern Med 2016; 213:1876–1885.
- Zhong W, Liu F, Wilson JR, et al. Antibody-dependent cell-mediated cytotoxicity to hemagglutinin of influenza A viruses after influenza vaccination in humans. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw102.
- Wright PF, Hoen AG, Ilyushina NA, et al. Correlates of immunity to influenza as determined by challenge of children with live, attenuated influenza vaccine. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw108.
- Reber AJ, Kim JH, Biber R, et al. Preexisting immunity, more than aging, influences influenza vaccine responses. Open Forum Infect Dis 2015; 2 doi:10.1093/ofid/ofv052.
- Loeb M, Russell ML, Manning V, et al. Live attenuated versus inactivated influenza vaccine in Hutterite children: a cluster randomized blinded trial. Ann Intern Med published online August 16, 2016. doi:10.7326/M16-0513.
- CDC Newsroom. ACIP votes down use of LAIV for 2016-2017 flu season. June 22, 2016. www.cdc.gov/media/releases/2016/s0622-laiv-flu.html. Accessed October 6, 2016.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity—United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Goodman K, Mossad SB, Taksler GB, et al. Impact of video education on influenza vaccination in pregnancy. J Reprod Med 2015; 60:471–479.
- Oboho IK, Reed C, Gargiullo P, et al. Benefit of early initiation of influenza antiviral treatment to pregnant women hospitalized with laboratory-confirmed influenza. J Infect Dis 2016; 214:507–515.
- Kashiwagi S, Watanabe A, Ikematsu H, Uemori M, Awamura S, for the Laninamivir Prophylaxis Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate as post-exposure prophylaxis for influenza. Clin Infect Dis 2016; 63:330–337.
The mass media and the medical literature have been saturated in the last few years by concerns about a variety of emerging viral epidemics such as Ebola and Zika. We must always remember that influenza will continue to affect many more patients worldwide.
The Cleveland Clinic Journal of Medicine periodically publishes updates on influenza, a topic befitting the large proportion of internists and internal medicine subspecialists who regularly read the Journal. This series began in 1975 with an article by Steven R. Mostow, MD,1 which followed three pandemics that changed the world’s attitude about influenza.
A lot has changed since then, including another pandemic in 2009–2010. Here, I review recent information relevant to daily practice.
NO REASON FOR COMPLACENCY
The relatively mild 2015–2016 influenza season is no reason for complacency this season.
Influenza activity in 2015–2016 was milder than in most seasons in the last decade.2 Activity peaked in mid-March and resulted in fewer outpatient visits, hospitalizations, and deaths than in previous seasons. Influenza A (H1N1)pdm09 has remained the predominant circulating virus since 2009. Although the overall rate of influenza-related hospitalization was less than half that in previous years, the hospitalization rate of middle-aged adults was relatively high (16.8 per 100,000 population). Importantly, 92% of adults with influenza illness that required hospitalization had at least one underlying medical condition, alerting us as healthcare providers that there is plenty of room for improvement in preventing such hospitalizations.
We should remain vigilant. We should put forth our best efforts in vaccinating all individuals above the age of 6 months and in diagnosing influenza early in the course of the illness in order to prescribe antiviral therapy within 48 hours of onset of symptoms. These actions not only shorten the illness and prevent hospitalization and secondary bacterial infection, but also reduce contagion and thus reduce overall healthcare costs.
School closure as a measure to halt epidemics has been lately called into question,3 since there are not enough data to support doing this routinely. School closure in Western Kentucky during the 2013 influenza epidemic did not reduce transmission but caused additional economic and social difficulties for certain households.4
STUDIES REINFORCE EARLIER DATA THAT INFLUENZA VACCINE WORKS
In the several decades since influenza vaccine became available, hundreds of studies have demonstrated the value of the “flu shot.” A few recent papers that support these well-established data:
- In adults who sought medical care for acute respiratory illness, influenza vaccine was 58.4% effective in preventing laboratory-confirmed influenza illness in adults age 50 and older.5
- In the same age group, influenza vaccine was 56.8% effective in preventing laboratory-confirmed influenza hospitalizations.6
- Influenza vaccination in patients with heart failure reduced all-cause hospitalizations, particularly cardiovascular hospitalizations (30% reduction) and hospitalizations for respiratory infections (16% reduction).7 This effect lasted up to 4 months after influenza vaccination.
- Patients who were hospitalized with community-acquired, laboratory-confirmed influenza pneumonia were 43% less likely to have received the influenza vaccine than patients hospitalized with community-acquired pneumonia due to other pathogens.8
INFLUENZA VACCINE IS EVEN MORE VALUABLE DURING PREGNANCY
Influenza vaccination during pregnancy prevented one in five preterm deliveries in a developing country9 and reduced the risk of stillbirth by 50% in Australia.10
An interesting collateral benefit was demonstrated in a survey conducted in Minnesota, where children of mothers who self-reported prenatal influenza vaccination were more likely to complete their routine childhood vaccination series.11
ADDITIONAL BENEFITS OF INFLUENZA VACCINATION
A recently appreciated benefit is that influenza vaccine induces cross-reactive protective immune responses (“heterologous immunity”) to viral strains not included in the vaccine, even in immunosuppressed individuals such as kidney transplant recipients.12 Interestingly, patients were more likely to seroconvert for a cross-reactive “heterologous” antigen if they also seroconverted for the vaccine-specific “homologous” antigen.
In a study in mice, an influenza vaccine with an adjuvant protected mice not only from influenza virus challenge, but also from a Staphylococcus aureus superinfection challenge.13 This novel idea suggests that influenza vaccine protects not only against influenza virus infection, but also against a potentially fatal secondary bacterial infection. This has significant implications for curbing antibacterial use, with an expected reduction in antimicrobial resistance.
Another important benefit of influenza vaccination was recently demonstrated when ferrets were intranasally inoculated with the highly pathogenic influenza A(H5N1) strain and then received either influenza vaccine or prophylactic oseltamivir. Ferrets that received the vaccine were less likely to develop severe meningoencephalitis.14 Since influenza A(H5N1) is much more virulent than the current circulating influenza strains, and since it may be the cause of the next pandemic, preventing such a serious complication of influenza would be lifesaving.
SAFETY OF INFLUENZA VACCINATION
Hundreds of studies involving thousands of people have established the safety of influenza vaccination.
Issues related to Guillain-Barré syndrome have long been put to rest. A large retrospective study found no evidence of increased risk of Guillain-Barré syndrome following vaccination of any kind, including influenza vaccination.15
Local reactions after vaccination are transient and do not interfere with the ability to perform daily activities.
In this era of utilization review, it is reassuring to know that giving influenza vaccine to hospitalized surgical patients was not associated with an increased rate of postdischarge fever or other clinical concern for infection requiring emergency room visits or rehospitalization.16
WHY INFLUENZA VACCINE MAY NOT PREVENT ALL CASES OF INFLUENZA
Whether neutralizing antibodies to influenza virus hemagglutinin antigen should be the main immune correlate of protection for influenza vaccines remains in question. Although prepandemic avian influenza vaccines are poorly immunogenic in inducing neutralizing antibodies, they confer considerable protection. A recent study showed that antibody-dependent cell-mediated cytotoxicity to hemagglutinin antigen in an avian influenza vaccine was a better predictor of protective capacity than neutralizing antibodies.17
Patterns of immunity induced by the live-attenuated influenza vaccine and the inactivated influenza vaccine are different.18 In fact, no single cytokine or chemokine measurement predicts protection.
Even though adults age 50 and older mount statistically significant humoral and cell-mediated immune responses to the inactivated vaccine, two-thirds do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H1N1), and one-fifth do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H3N2).19 While age had some negative effect on vaccine responsiveness, prevaccination titers were much better at predicting postvaccination antibody levels.
ONGOING DEBATE OVER LIVE-ATTENUATED INFLUENZA VACCINE
Several studies had shown that the live-attenuated influenza vaccine, given intranasally, was not only more protective in vaccinated children, but also provided herd protection in unvaccinated contacts. However, a recently published study conducted in Canadian Hutterite children showed that the live-attenuated vaccine did not result in herd immunity when compared to the inactivated influenza vaccine.20
On June 22, 2016, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended against the use of the live-attenuated vaccine for the 2016–2017 season,21 based on data showing negligible protection conferred by the live-attenuated influenza vaccine in the three preceding influenza seasons.
This decision created significant debate among experts in the field. It is unclear why the live-attenuated influenza vaccine was much less protective in the last three seasons than in prior seasons. Recommending against its use in the United States will essentially eliminate any possibility of reassessing its efficacy in this country. Of note, the quadrivalent live-attenuated influenza vaccine had recently replaced the previous trivalent live-attenuated vaccine, which may have introduced some “competition” among the vaccine strains to infect enough cells to allow viral replication and subsequent immune response. Another potential explanation is that consistent annual vaccination may have resulted in a cumulative immunity that could hamper response to subsequent doses.
COMPOSITION OF THE 2016–2017 INFLUENZA VACCINE
The 2016–2017 quadrivalent inactivated influenza vaccine will contain22:
- A/California/7/2009 (H1N1)pdm09-like virus
- A/Hong Kong/4801/2014 (H3N2)-like virus
- B/Brisbane/60/2008-like virus (B/Victoria lineage)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage).
This represents a change in the A (H3N2) component compared with the 2015–2016 vaccine.
Influenza vaccine manufacturers estimated they would produce 170 million doses for distribution in the United States for the upcoming influenza season. The previously mentioned recommendation against the use of the live-attenuated vaccine, which accounts for approximately 8% of the influenza vaccine supply, may affect vaccine uptake, particularly in children.
NEW ANTI-INFLUENZA AGENTS AND UPDATE ON EXISTING AGENTS
Neuraminidase inhibitors are the only class of antiviral drugs currently recommended for prevention and treatment of influenza. The three products currently available in the United States are oseltamivir, zanamivir, and peramivir. Oseltamivir is administered orally, and the first generic version was approved by the US Food and Drug Administration on August 3, 2016. Zanamivir is administered by oral inhalation. Both oseltamivir and zanamivir are approved for treatment and prevention of influenza. Peramivir is administered intravenously as a single dose and is approved only for the treatment of acute influenza, not prevention.
Unfortunately, the influenza vaccination rate during pregnancy in the United States remains only around 50%.23 Physicians’ recommendations are strongly associated with vaccine uptake, particularly when they emphasize protective effect on the newborn. Influenza during pregnancy carries higher mortality than in the general population, with collateral fetal loss.
Early initiation of antiviral therapy is particularly imperative during pregnancy. A recent study showed that starting antiviral therapy within 2 days of onset of illness in pregnant women hospitalized with severe influenza reduced length of stay by 5.6 days compared with those in whom therapy was started more than 2 days after illness onset.24
A single dose of laninamivir octanoate, a long-acting neuraminidase inhibitor currently approved in Japan for treating influenza, was recently shown to be effective as postexposure prophylaxis.25 This option may be convenient for people who prefer not to take a daily medication for several days, or in an outbreak in a healthcare facility.
The mass media and the medical literature have been saturated in the last few years by concerns about a variety of emerging viral epidemics such as Ebola and Zika. We must always remember that influenza will continue to affect many more patients worldwide.
The Cleveland Clinic Journal of Medicine periodically publishes updates on influenza, a topic befitting the large proportion of internists and internal medicine subspecialists who regularly read the Journal. This series began in 1975 with an article by Steven R. Mostow, MD,1 which followed three pandemics that changed the world’s attitude about influenza.
A lot has changed since then, including another pandemic in 2009–2010. Here, I review recent information relevant to daily practice.
NO REASON FOR COMPLACENCY
The relatively mild 2015–2016 influenza season is no reason for complacency this season.
Influenza activity in 2015–2016 was milder than in most seasons in the last decade.2 Activity peaked in mid-March and resulted in fewer outpatient visits, hospitalizations, and deaths than in previous seasons. Influenza A (H1N1)pdm09 has remained the predominant circulating virus since 2009. Although the overall rate of influenza-related hospitalization was less than half that in previous years, the hospitalization rate of middle-aged adults was relatively high (16.8 per 100,000 population). Importantly, 92% of adults with influenza illness that required hospitalization had at least one underlying medical condition, alerting us as healthcare providers that there is plenty of room for improvement in preventing such hospitalizations.
We should remain vigilant. We should put forth our best efforts in vaccinating all individuals above the age of 6 months and in diagnosing influenza early in the course of the illness in order to prescribe antiviral therapy within 48 hours of onset of symptoms. These actions not only shorten the illness and prevent hospitalization and secondary bacterial infection, but also reduce contagion and thus reduce overall healthcare costs.
School closure as a measure to halt epidemics has been lately called into question,3 since there are not enough data to support doing this routinely. School closure in Western Kentucky during the 2013 influenza epidemic did not reduce transmission but caused additional economic and social difficulties for certain households.4
STUDIES REINFORCE EARLIER DATA THAT INFLUENZA VACCINE WORKS
In the several decades since influenza vaccine became available, hundreds of studies have demonstrated the value of the “flu shot.” A few recent papers that support these well-established data:
- In adults who sought medical care for acute respiratory illness, influenza vaccine was 58.4% effective in preventing laboratory-confirmed influenza illness in adults age 50 and older.5
- In the same age group, influenza vaccine was 56.8% effective in preventing laboratory-confirmed influenza hospitalizations.6
- Influenza vaccination in patients with heart failure reduced all-cause hospitalizations, particularly cardiovascular hospitalizations (30% reduction) and hospitalizations for respiratory infections (16% reduction).7 This effect lasted up to 4 months after influenza vaccination.
- Patients who were hospitalized with community-acquired, laboratory-confirmed influenza pneumonia were 43% less likely to have received the influenza vaccine than patients hospitalized with community-acquired pneumonia due to other pathogens.8
INFLUENZA VACCINE IS EVEN MORE VALUABLE DURING PREGNANCY
Influenza vaccination during pregnancy prevented one in five preterm deliveries in a developing country9 and reduced the risk of stillbirth by 50% in Australia.10
An interesting collateral benefit was demonstrated in a survey conducted in Minnesota, where children of mothers who self-reported prenatal influenza vaccination were more likely to complete their routine childhood vaccination series.11
ADDITIONAL BENEFITS OF INFLUENZA VACCINATION
A recently appreciated benefit is that influenza vaccine induces cross-reactive protective immune responses (“heterologous immunity”) to viral strains not included in the vaccine, even in immunosuppressed individuals such as kidney transplant recipients.12 Interestingly, patients were more likely to seroconvert for a cross-reactive “heterologous” antigen if they also seroconverted for the vaccine-specific “homologous” antigen.
In a study in mice, an influenza vaccine with an adjuvant protected mice not only from influenza virus challenge, but also from a Staphylococcus aureus superinfection challenge.13 This novel idea suggests that influenza vaccine protects not only against influenza virus infection, but also against a potentially fatal secondary bacterial infection. This has significant implications for curbing antibacterial use, with an expected reduction in antimicrobial resistance.
Another important benefit of influenza vaccination was recently demonstrated when ferrets were intranasally inoculated with the highly pathogenic influenza A(H5N1) strain and then received either influenza vaccine or prophylactic oseltamivir. Ferrets that received the vaccine were less likely to develop severe meningoencephalitis.14 Since influenza A(H5N1) is much more virulent than the current circulating influenza strains, and since it may be the cause of the next pandemic, preventing such a serious complication of influenza would be lifesaving.
SAFETY OF INFLUENZA VACCINATION
Hundreds of studies involving thousands of people have established the safety of influenza vaccination.
Issues related to Guillain-Barré syndrome have long been put to rest. A large retrospective study found no evidence of increased risk of Guillain-Barré syndrome following vaccination of any kind, including influenza vaccination.15
Local reactions after vaccination are transient and do not interfere with the ability to perform daily activities.
In this era of utilization review, it is reassuring to know that giving influenza vaccine to hospitalized surgical patients was not associated with an increased rate of postdischarge fever or other clinical concern for infection requiring emergency room visits or rehospitalization.16
WHY INFLUENZA VACCINE MAY NOT PREVENT ALL CASES OF INFLUENZA
Whether neutralizing antibodies to influenza virus hemagglutinin antigen should be the main immune correlate of protection for influenza vaccines remains in question. Although prepandemic avian influenza vaccines are poorly immunogenic in inducing neutralizing antibodies, they confer considerable protection. A recent study showed that antibody-dependent cell-mediated cytotoxicity to hemagglutinin antigen in an avian influenza vaccine was a better predictor of protective capacity than neutralizing antibodies.17
Patterns of immunity induced by the live-attenuated influenza vaccine and the inactivated influenza vaccine are different.18 In fact, no single cytokine or chemokine measurement predicts protection.
Even though adults age 50 and older mount statistically significant humoral and cell-mediated immune responses to the inactivated vaccine, two-thirds do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H1N1), and one-fifth do not reach hemagglutination inhibition antibody titers of 40 or higher for influenza A(H3N2).19 While age had some negative effect on vaccine responsiveness, prevaccination titers were much better at predicting postvaccination antibody levels.
ONGOING DEBATE OVER LIVE-ATTENUATED INFLUENZA VACCINE
Several studies had shown that the live-attenuated influenza vaccine, given intranasally, was not only more protective in vaccinated children, but also provided herd protection in unvaccinated contacts. However, a recently published study conducted in Canadian Hutterite children showed that the live-attenuated vaccine did not result in herd immunity when compared to the inactivated influenza vaccine.20
On June 22, 2016, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended against the use of the live-attenuated vaccine for the 2016–2017 season,21 based on data showing negligible protection conferred by the live-attenuated influenza vaccine in the three preceding influenza seasons.
This decision created significant debate among experts in the field. It is unclear why the live-attenuated influenza vaccine was much less protective in the last three seasons than in prior seasons. Recommending against its use in the United States will essentially eliminate any possibility of reassessing its efficacy in this country. Of note, the quadrivalent live-attenuated influenza vaccine had recently replaced the previous trivalent live-attenuated vaccine, which may have introduced some “competition” among the vaccine strains to infect enough cells to allow viral replication and subsequent immune response. Another potential explanation is that consistent annual vaccination may have resulted in a cumulative immunity that could hamper response to subsequent doses.
COMPOSITION OF THE 2016–2017 INFLUENZA VACCINE
The 2016–2017 quadrivalent inactivated influenza vaccine will contain22:
- A/California/7/2009 (H1N1)pdm09-like virus
- A/Hong Kong/4801/2014 (H3N2)-like virus
- B/Brisbane/60/2008-like virus (B/Victoria lineage)
- B/Phuket/3073/2013-like virus (B/Yamagata lineage).
This represents a change in the A (H3N2) component compared with the 2015–2016 vaccine.
Influenza vaccine manufacturers estimated they would produce 170 million doses for distribution in the United States for the upcoming influenza season. The previously mentioned recommendation against the use of the live-attenuated vaccine, which accounts for approximately 8% of the influenza vaccine supply, may affect vaccine uptake, particularly in children.
NEW ANTI-INFLUENZA AGENTS AND UPDATE ON EXISTING AGENTS
Neuraminidase inhibitors are the only class of antiviral drugs currently recommended for prevention and treatment of influenza. The three products currently available in the United States are oseltamivir, zanamivir, and peramivir. Oseltamivir is administered orally, and the first generic version was approved by the US Food and Drug Administration on August 3, 2016. Zanamivir is administered by oral inhalation. Both oseltamivir and zanamivir are approved for treatment and prevention of influenza. Peramivir is administered intravenously as a single dose and is approved only for the treatment of acute influenza, not prevention.
Unfortunately, the influenza vaccination rate during pregnancy in the United States remains only around 50%.23 Physicians’ recommendations are strongly associated with vaccine uptake, particularly when they emphasize protective effect on the newborn. Influenza during pregnancy carries higher mortality than in the general population, with collateral fetal loss.
Early initiation of antiviral therapy is particularly imperative during pregnancy. A recent study showed that starting antiviral therapy within 2 days of onset of illness in pregnant women hospitalized with severe influenza reduced length of stay by 5.6 days compared with those in whom therapy was started more than 2 days after illness onset.24
A single dose of laninamivir octanoate, a long-acting neuraminidase inhibitor currently approved in Japan for treating influenza, was recently shown to be effective as postexposure prophylaxis.25 This option may be convenient for people who prefer not to take a daily medication for several days, or in an outbreak in a healthcare facility.
- Mostow SR. Current perspectives of influenza. Cleve Clin J Med 1975; 42:63–70.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity — United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Sasaki A, Hoen AG, Al Ozonoff A, et al. Evidence-based tool for triggering school closures during influenza outbreaks, Japan. Emerg Infect Dis 2009; 15:1841–1843.
- Russell ES, Zheteyeva Y, Gao H, et al. Reactive school closure during increased influenza-like Illness (ILI) activity in Western Kentucky, 2013: a field evaluation of effect on ILI incidence and economic and social consequences for families. Open Forum Infect Dis (Summer 2016) 3 (3): first published online May 25, 2016. doi:10.1093/ofid/ofw113.
- Chen Q, Griffin MR, Nian H, et al. Influenza vaccine prevents medically attended influenza-associated acute respiratory illness in adults aged ≥ 50 years. J Infect Dis 2015, 211:1045–1050.
- Havers FP, Sokolow L, Shay DK, et al. Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010–11. Clin Infect Dis 2016. [Epub ahead of print.].
- Influenza vaccination linked to fewer CV, respiratory hospitalizations in patients with HF. Helio Cardiology Today, May 25, 2016. www.healio.com/cardiology/hf-transplantation/news/online/%7B5292db4f-fc81-43f2-a28d-c124f2a6331b%7D/influenza-vaccination-linked-to-fewer-cv-respiratory-hospitalizations-in-patients-with-hf. Accessed October 6, 2016.
- Grijalva CG, Zhu Y, Williams DJ, et al. Association between hospitalization with community-acquired laboratory-confirmed influenza pneumonia and prior receipt of influenza vaccination. JAMA 2015, 314:1488–1497.
- Olsen SJ, Mirza SA, Vonglokham P, et al. The effect of influenza vaccination on birth outcomes in a cohort of pregnant women in Lao PDR, 2014–2015. Clin Infect Dis 2016; 63:487–494.
- Regan AK, Moore HC, de Klerk N, et al. Seasonal trivalent influenza vaccination during pregnancy and the incidence of stillbirth: population-based retrospective cohort study. Clin Infect Dis 2016; 62:1221–1227.
- Fuchs EL. Self-reported prenatal influenza vaccination and early childhood vaccine series completion. Prev Med 2016; 88:8–12.
- Kumar D, Ferreira VH, Campbell P, Hoschler K, Humar A. Heterologous immune responses to influenza vaccine in kidney transplant recipients. Am J Transplant 2016; accepted manuscript online: 12 Jul 2016; doi: 10.1111/ajt.13960. [Epub ahead of print.]
- Zurli V, Gallotta M, Taccone M, et al. Positive contribution of adjuvanted influenza vaccines to the resolution of bacterial superinfections. J Infect Dis 2016; 213:1876–1885.
- Siegers JY, van den Brand JM, Leijten LM, et al. Vaccination is more effective than prophylactic oseltamivir in preventing CNS invasion by H5N1 virus via the olfactory nerve. J Infect Dis 2016; 214:516–524.
- Baxter R, Bakshi N, Fireman B, et al. Lack of association of Guillain-Barré syndrome with vaccinations. Clin Infect Dis 2013; 57:197–204.
- Tartof SY, Qian L, Rieg G, et al. Safety of seasonal Influenza vaccination in hospitalized surgical patients: a cohort study. Ann Intern Med 2016; 213:1876–1885.
- Zhong W, Liu F, Wilson JR, et al. Antibody-dependent cell-mediated cytotoxicity to hemagglutinin of influenza A viruses after influenza vaccination in humans. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw102.
- Wright PF, Hoen AG, Ilyushina NA, et al. Correlates of immunity to influenza as determined by challenge of children with live, attenuated influenza vaccine. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw108.
- Reber AJ, Kim JH, Biber R, et al. Preexisting immunity, more than aging, influences influenza vaccine responses. Open Forum Infect Dis 2015; 2 doi:10.1093/ofid/ofv052.
- Loeb M, Russell ML, Manning V, et al. Live attenuated versus inactivated influenza vaccine in Hutterite children: a cluster randomized blinded trial. Ann Intern Med published online August 16, 2016. doi:10.7326/M16-0513.
- CDC Newsroom. ACIP votes down use of LAIV for 2016-2017 flu season. June 22, 2016. www.cdc.gov/media/releases/2016/s0622-laiv-flu.html. Accessed October 6, 2016.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity—United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Goodman K, Mossad SB, Taksler GB, et al. Impact of video education on influenza vaccination in pregnancy. J Reprod Med 2015; 60:471–479.
- Oboho IK, Reed C, Gargiullo P, et al. Benefit of early initiation of influenza antiviral treatment to pregnant women hospitalized with laboratory-confirmed influenza. J Infect Dis 2016; 214:507–515.
- Kashiwagi S, Watanabe A, Ikematsu H, Uemori M, Awamura S, for the Laninamivir Prophylaxis Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate as post-exposure prophylaxis for influenza. Clin Infect Dis 2016; 63:330–337.
- Mostow SR. Current perspectives of influenza. Cleve Clin J Med 1975; 42:63–70.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity — United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Sasaki A, Hoen AG, Al Ozonoff A, et al. Evidence-based tool for triggering school closures during influenza outbreaks, Japan. Emerg Infect Dis 2009; 15:1841–1843.
- Russell ES, Zheteyeva Y, Gao H, et al. Reactive school closure during increased influenza-like Illness (ILI) activity in Western Kentucky, 2013: a field evaluation of effect on ILI incidence and economic and social consequences for families. Open Forum Infect Dis (Summer 2016) 3 (3): first published online May 25, 2016. doi:10.1093/ofid/ofw113.
- Chen Q, Griffin MR, Nian H, et al. Influenza vaccine prevents medically attended influenza-associated acute respiratory illness in adults aged ≥ 50 years. J Infect Dis 2015, 211:1045–1050.
- Havers FP, Sokolow L, Shay DK, et al. Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010–11. Clin Infect Dis 2016. [Epub ahead of print.].
- Influenza vaccination linked to fewer CV, respiratory hospitalizations in patients with HF. Helio Cardiology Today, May 25, 2016. www.healio.com/cardiology/hf-transplantation/news/online/%7B5292db4f-fc81-43f2-a28d-c124f2a6331b%7D/influenza-vaccination-linked-to-fewer-cv-respiratory-hospitalizations-in-patients-with-hf. Accessed October 6, 2016.
- Grijalva CG, Zhu Y, Williams DJ, et al. Association between hospitalization with community-acquired laboratory-confirmed influenza pneumonia and prior receipt of influenza vaccination. JAMA 2015, 314:1488–1497.
- Olsen SJ, Mirza SA, Vonglokham P, et al. The effect of influenza vaccination on birth outcomes in a cohort of pregnant women in Lao PDR, 2014–2015. Clin Infect Dis 2016; 63:487–494.
- Regan AK, Moore HC, de Klerk N, et al. Seasonal trivalent influenza vaccination during pregnancy and the incidence of stillbirth: population-based retrospective cohort study. Clin Infect Dis 2016; 62:1221–1227.
- Fuchs EL. Self-reported prenatal influenza vaccination and early childhood vaccine series completion. Prev Med 2016; 88:8–12.
- Kumar D, Ferreira VH, Campbell P, Hoschler K, Humar A. Heterologous immune responses to influenza vaccine in kidney transplant recipients. Am J Transplant 2016; accepted manuscript online: 12 Jul 2016; doi: 10.1111/ajt.13960. [Epub ahead of print.]
- Zurli V, Gallotta M, Taccone M, et al. Positive contribution of adjuvanted influenza vaccines to the resolution of bacterial superinfections. J Infect Dis 2016; 213:1876–1885.
- Siegers JY, van den Brand JM, Leijten LM, et al. Vaccination is more effective than prophylactic oseltamivir in preventing CNS invasion by H5N1 virus via the olfactory nerve. J Infect Dis 2016; 214:516–524.
- Baxter R, Bakshi N, Fireman B, et al. Lack of association of Guillain-Barré syndrome with vaccinations. Clin Infect Dis 2013; 57:197–204.
- Tartof SY, Qian L, Rieg G, et al. Safety of seasonal Influenza vaccination in hospitalized surgical patients: a cohort study. Ann Intern Med 2016; 213:1876–1885.
- Zhong W, Liu F, Wilson JR, et al. Antibody-dependent cell-mediated cytotoxicity to hemagglutinin of influenza A viruses after influenza vaccination in humans. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw102.
- Wright PF, Hoen AG, Ilyushina NA, et al. Correlates of immunity to influenza as determined by challenge of children with live, attenuated influenza vaccine. Open Forum Infect Dis 2016; 3: doi:10.1093/ofid/ofw108.
- Reber AJ, Kim JH, Biber R, et al. Preexisting immunity, more than aging, influences influenza vaccine responses. Open Forum Infect Dis 2015; 2 doi:10.1093/ofid/ofv052.
- Loeb M, Russell ML, Manning V, et al. Live attenuated versus inactivated influenza vaccine in Hutterite children: a cluster randomized blinded trial. Ann Intern Med published online August 16, 2016. doi:10.7326/M16-0513.
- CDC Newsroom. ACIP votes down use of LAIV for 2016-2017 flu season. June 22, 2016. www.cdc.gov/media/releases/2016/s0622-laiv-flu.html. Accessed October 6, 2016.
- Davlin SL, Blanton L, Kniss K, et al. Influenza activity—United States, 2015–16 season and composition of the 2016–17 influenza vaccine. MMWR Morb Mortal Wkly Rep 2016; 65:567–575.
- Goodman K, Mossad SB, Taksler GB, et al. Impact of video education on influenza vaccination in pregnancy. J Reprod Med 2015; 60:471–479.
- Oboho IK, Reed C, Gargiullo P, et al. Benefit of early initiation of influenza antiviral treatment to pregnant women hospitalized with laboratory-confirmed influenza. J Infect Dis 2016; 214:507–515.
- Kashiwagi S, Watanabe A, Ikematsu H, Uemori M, Awamura S, for the Laninamivir Prophylaxis Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate as post-exposure prophylaxis for influenza. Clin Infect Dis 2016; 63:330–337.
KEY POINTS
- Influenza vaccine remains the most effective way to prevent influenza. Healthcare providers should continue to vaccinate all people older than 6 months.
- For the 2016–2017 influenza season, only the inactivated influenza vaccine, not the live-attenuated vaccine, is recommended, regardless of age group or underlying disease.
- Early initiation of a neuraminidase inhibitor is advised for an influenza-like illness while awaiting a confirmatory diagnostic test.
2014-2015 influenza vaccine ineffective against predominant strain
The 2014-2015 influenza vaccines offered little protection against the predominant influenza A/H3N2 virus, but were effective against influenza B, according to the vaccine effectiveness estimates provided by the U.S. Flu Vaccine Effectiveness Network.
Preferential use of the live attenuated influenza vaccine (LAIV) among young children, a recommendation previously published by the Advisory Committee on Immunization Practices, was not supported.
During the 2014-2015 influenza season, a total of 9,710 patients seeking outpatient medical treatment for acute respiratory infection with cough were enrolled into the U.S. Flu Vaccine Effectiveness study, reported Richard Zimmerman, MD, of the University of Pittsburgh, and his colleagues (Clin Infect Dis. 2016 Oct 4. doi: 10.1093/cid/ciw635).
Of these, 9,311 participants had complete data, and 7,078 (76%) tested negative for influenza. A total of 1,840 participants tested positive for influenza A – 99% of these cases were strain A/H3N2 – and 395 participants tested positive for influenza B.
Of the 4,360 vaccinated participants with known vaccine type, 39.7% received standard dose trivalent, 1.6% received high dose trivalent, 46.8% received standard dose quadrivalent, and 11.9% received quadrivalent live-attenuated vaccines.
For influenza A and B combined, the overall adjusted vaccine effectiveness was 19% (95% Confidence Interval, 10-27%) against all medically attended influenza and was statistically significant in all age groups except 18-49 years.
Across all vaccine types, the vaccine effectiveness for the A/H3N2 strain was 6% (95% CI, -5-17%), estimates were similar across all age groups, and all vaccine types were similarly ineffective. These estimates were “consistent with a mismatch between the vaccine and circulating viruses,” the researchers noted.
Overall vaccine effectiveness for influenza B/Yamagata was 55% (95% CI, 43% to 65%) and was similarly significant in all age strata except 50-64 year olds. Trivalent vaccines were more effective at preventing influenza B and, of note, no cases of influenza B occurred among those who received a high dose trivalent flu vaccine.
The study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Zimmerman and four other investigators reported receiving research funding from several pharmaceutical companies.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
The 2014-2015 influenza vaccines offered little protection against the predominant influenza A/H3N2 virus, but were effective against influenza B, according to the vaccine effectiveness estimates provided by the U.S. Flu Vaccine Effectiveness Network.
Preferential use of the live attenuated influenza vaccine (LAIV) among young children, a recommendation previously published by the Advisory Committee on Immunization Practices, was not supported.
During the 2014-2015 influenza season, a total of 9,710 patients seeking outpatient medical treatment for acute respiratory infection with cough were enrolled into the U.S. Flu Vaccine Effectiveness study, reported Richard Zimmerman, MD, of the University of Pittsburgh, and his colleagues (Clin Infect Dis. 2016 Oct 4. doi: 10.1093/cid/ciw635).
Of these, 9,311 participants had complete data, and 7,078 (76%) tested negative for influenza. A total of 1,840 participants tested positive for influenza A – 99% of these cases were strain A/H3N2 – and 395 participants tested positive for influenza B.
Of the 4,360 vaccinated participants with known vaccine type, 39.7% received standard dose trivalent, 1.6% received high dose trivalent, 46.8% received standard dose quadrivalent, and 11.9% received quadrivalent live-attenuated vaccines.
For influenza A and B combined, the overall adjusted vaccine effectiveness was 19% (95% Confidence Interval, 10-27%) against all medically attended influenza and was statistically significant in all age groups except 18-49 years.
Across all vaccine types, the vaccine effectiveness for the A/H3N2 strain was 6% (95% CI, -5-17%), estimates were similar across all age groups, and all vaccine types were similarly ineffective. These estimates were “consistent with a mismatch between the vaccine and circulating viruses,” the researchers noted.
Overall vaccine effectiveness for influenza B/Yamagata was 55% (95% CI, 43% to 65%) and was similarly significant in all age strata except 50-64 year olds. Trivalent vaccines were more effective at preventing influenza B and, of note, no cases of influenza B occurred among those who received a high dose trivalent flu vaccine.
The study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Zimmerman and four other investigators reported receiving research funding from several pharmaceutical companies.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
The 2014-2015 influenza vaccines offered little protection against the predominant influenza A/H3N2 virus, but were effective against influenza B, according to the vaccine effectiveness estimates provided by the U.S. Flu Vaccine Effectiveness Network.
Preferential use of the live attenuated influenza vaccine (LAIV) among young children, a recommendation previously published by the Advisory Committee on Immunization Practices, was not supported.
During the 2014-2015 influenza season, a total of 9,710 patients seeking outpatient medical treatment for acute respiratory infection with cough were enrolled into the U.S. Flu Vaccine Effectiveness study, reported Richard Zimmerman, MD, of the University of Pittsburgh, and his colleagues (Clin Infect Dis. 2016 Oct 4. doi: 10.1093/cid/ciw635).
Of these, 9,311 participants had complete data, and 7,078 (76%) tested negative for influenza. A total of 1,840 participants tested positive for influenza A – 99% of these cases were strain A/H3N2 – and 395 participants tested positive for influenza B.
Of the 4,360 vaccinated participants with known vaccine type, 39.7% received standard dose trivalent, 1.6% received high dose trivalent, 46.8% received standard dose quadrivalent, and 11.9% received quadrivalent live-attenuated vaccines.
For influenza A and B combined, the overall adjusted vaccine effectiveness was 19% (95% Confidence Interval, 10-27%) against all medically attended influenza and was statistically significant in all age groups except 18-49 years.
Across all vaccine types, the vaccine effectiveness for the A/H3N2 strain was 6% (95% CI, -5-17%), estimates were similar across all age groups, and all vaccine types were similarly ineffective. These estimates were “consistent with a mismatch between the vaccine and circulating viruses,” the researchers noted.
Overall vaccine effectiveness for influenza B/Yamagata was 55% (95% CI, 43% to 65%) and was similarly significant in all age strata except 50-64 year olds. Trivalent vaccines were more effective at preventing influenza B and, of note, no cases of influenza B occurred among those who received a high dose trivalent flu vaccine.
The study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Zimmerman and four other investigators reported receiving research funding from several pharmaceutical companies.
jcraig@frontlinemedcom.com
On Twitter @jessnicolecraig
Key clinical point:
Major finding: Across all vaccine types, the vaccine effectiveness for the A/H3N2 strain was 6%.
Data source: Retrospective analysis of 9,710 patients who sought outpatient medical treatment during the 2014-2015 influenza season.
Disclosures: The study was supported by the Centers for Disease Control and Prevention and the National Institutes of Health. Dr. Zimmerman and four other investigators reported receiving research funding from several pharmaceutical companies.
ACIP approves changes to HPV, Tdap, DTaP, MenB vaccination guidance
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose.
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose.
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices approved a series of minor changes to the current guidance for meningococcal, Tdap, DTaP, and human papillomavirus vaccination schedules.
Regarding meningococcal vaccinations, the committee voted to change the recommendations to state that individuals who are at an increased risk of contracting the disease should receive a three-dose regimen of Trumenba at 0 months, 1-2 months, and 6 months. The same regimen also should apply during any outbreaks of serogroup B meningococcal virus. In addition, a two-dose regimen at 0 and 6 months should be given to adolescents who are not considered high risk, and if the second dose is given fewer than 6 months following the first, then a third dose must be given within 6 months of the initial dose.
“This new recommendation enables flexible vaccination dosing intervals depending on one’s risk of exposure to meningococcal group B disease, also known as MenB, which makes it easier for health care providers to help protect adolescents and young adults from this uncommon but life-threatening disease,” the CDC announced in a statement.
For Tdap and DTaP vaccines, changes to the language of the recommendations were approved unanimously by the committee. These changes will contain the routine recommendations for DTaP, Tdap, and TB, which previously were published as separate statements, along with Tdap recommendations made after the 2005 recommendations and published in Morbidity and Mortality Weekly Report policy notes.
“This statement also contains updates, such as DTaP vaccines that became available after the 1997 DTaP statement, and updates to the label indications on various DTaP and Tdap products,” Jennifer Liang, DVM, of the CDC’s National Center for Immunization and Respiratory Diseases, explained at the ACIP meeting. “Also included in the statement are the following updates: mention of the discontinuation of monovalent tetanus toxoid vaccine, the contraindications and precautions for DTaP are now consistent with the [American Academy of Pediatrics’] Red Book, and for persons aged 7-10 years who received a dose of Tdap as part of the catchup series, an adolescent Tdap dose may be given at age 11-12 years.”
Dr. Liang added that these updated changes would bring the guidance in line with the recommendations for children who are administered Tdap inadvertently.
With one recusal, changes to the HPV vaccination guidance also were unanimously approved. No changes were proposed to the routine and catch-up age groups for HPV vaccination, and for contraindications and precautions. Major additions were made, however, to the sections on dosing schedules, and people with prior vaccination. Clarifying language was added for the sections on interrupted schedules, special populations, and medical conditions.
For individuals initiating vaccination before the 15th birthday, the recommended immunization schedule is two doses of HPV vaccine. The second dose should be administered 6-12 months after the first dose (0 months, 6-12 months schedule). For people initiating vaccination on or after the 15th birthday, the recommendations remain the same as before: three doses of HPV vaccine, with the second dose administered 1-2 months after the first dose, and the third dose administered within 6 months of the first dose.
Those with prior vaccinations who initiated with 9-valent HPV, 4-valent HPV, or 2-valent HPV before their 15th birthday and received either two or three doses at the recommended dosing schedule should be considered adequately vaccinated. Those who initiated any of those three HPV vaccinations on or after their 15th birthday and received three doses at the currently recommended dosing schedule should be considered adequately vaccinated, too.
With regard to the minimum intervals, the proposed change was to add a footnote defining minimum intervals: in a two-dose series of HPV vaccines, the minimum interval is 5 months between the first and second dose, and in a three-dose series, 5 months between the first and third dose. All other language remains as is. Special population language also was changed to “gay, bisexual, and other” men rather than simply men who have sex with men, to broaden the scope of the language. Language also will be amended to include transgender patients.
Finally, for those with other medical conditions, ACIP still recommends that all immunocompromised males and females aged 9-26 years get a three-dose HPV vaccination at 0, 1-2, and 6 months, but now the language change will read that “Persons who should receive three doses are those with primary or secondary immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasm, transplantation, autoimmune disease, or immunosuppressive therapy, since response to vaccination may be attenuated.”
In addition, there will be a footnote stating that these recommendations for a three-dose schedule do not apply to children under the age of 15 years with asplenia, asthma, chronic granulomatous disease, chronic heart/liver/lung/renal disease, central nervous system anatomic barrier defects, complement deficiency, diabetes, or sickle cell disease.”
The recommendations agreed upon will be submitted for approval to CDC Director Tom Frieden, MD. If approved, the recommendations will be published by Jan. 1, 2017, at which point, they will go into effect.
FROM AN ACIP MEETING
Use of 2D bar coding with vaccines may be the future in pediatric practice
ATLANTA – Since the first bar coded consumer product, a pack of gum, was scanned in June of 1974, the soon widespread use of bar codes changed little until 2D bar codes arrived toward the end of last century. Today, the increasing use of 2D bar code technology with vaccines offers practices the potential for greater accuracy and efficiency with vaccine administration and data entry – if they have the resources to take the plunge.
An overview of 2D bar code use with vaccines, presented at a conference sponsored by the Centers for Disease Control and Prevention, provided a glimpse into both the types of changes practices might see with adoption of the technology and the way some clinics have made the transition.
Ken Gerlach, MPH, of the Immunization Services Division at the CDC in Atlanta, outlined the history of bar code use in immunizations, starting with a November 1999 Institute of Medicine report that identified the contribution of human error to disease and led the Food and Drug Administration to begin requiring linear bar codes on pharmaceutical unit-of-use products to reduce errors.
Then, a meeting organized by the American Academy of Pediatrics in January 2009 with the FDA, CDC, vaccine manufacturers, and other stakeholders led to a bar code rule change by the FDA in August 2011 that allowed alternatives to the traditional linear bar codes on vaccine vials and syringes.
“They essentially indicated to the pharmaceutical companies that it’s okay to add 2D bar codes, and this is essentially the point where things began to take off,” Mr. Gerlach explained. Until then, there had been no 2D bar codes on vaccines, but today the majority of vaccine products have them, as do all Vaccine Information Statements. In addition to the standard information included on traditional bar codes – Global Trade Item Number (GTIN), lot and serial numbers, and the expiration date – 2D bar codes also can include most relevant patient information that would go into the EMR except the injection site and immunization route. But a practice cannot simply jump over to scanning the 2D bar codes without ensuring that its EMR system is configured to accept the scanning.
Mr. Gerlach described a three-part project by the CDC, from 2011 through 2017, that assesses the impact of 2D coding on vaccination data quality and work flow, facilitates the adoption of 2D bar code scanning in health care practices, and then assesses the potential for expanding 2D bar code use in a large health care system. The first part of the project, which ran from 2011 to 2014, involved two vaccine manufacturers and 217 health care practices with more than 1.4 million de-identified vaccination records, 18.1% of which had been 2D bar coded.
Analysis of data quality from that pilot revealed an 8% increase in the correctness of lot numbers and 11% increase for expiration dates, with a time savings of 3.4 seconds per vaccine administration. Among the 116 staff users who completed surveys, 86% agreed that 2D bar coding improves accuracy and completeness, and 60% agreed it was easy to integrate the bar coding into their usual data recording process.
The pilot revealed challenges as well, however: not all individuals units of vaccines were 2D bar coded, users did not always consistently scan the bar codes, and some bar codes were difficult to read, such as one that was brown and wouldn’t scan. Another obstacle was having different lot numbers on the unit of use versus the unit of sale with 10% of the vaccines. Further, because inventory management typically involves unit of sale, it does not always match well with scanning unit of use.
Clinicians’ beliefs and attitudes toward 2D bar coding
As more practices consider adopting the technology, buy-in will important. At the conference, Sharon Humiston, MD, and Jill Hernandez, MPH, of Children’s Mercy Hospital in Kansas City, Mo., shared the findings of an online questionnaire about 2D bar coding and practices’ current systems for vaccine inventory and recording patient immunization information. The researchers distributed the questionnaire link to various AAP sections and committees in listservs and emails. Those eligible to complete the 15-minute survey were primary care personnel who used EMRs but not 2D bar code scanning for vaccines. They also needed to be key decision makers in the process of purchasing technology for the practice, and their practice needed to be enrolled in the Vaccines for Children program.
Among the 77 respondents who met all the inclusion criteria (61% of all who started the survey), 1 in 5 were private practices with one or two physicians, just over a third (36%) were private practices with more than two physicians, and a quarter were multispecialty group practices. Overall, respondents administered an average 116 doses of DTaP and 50 doses of Tdap each month.
Protocols for immunization management varied considerably across the respondents. For recording vaccine information, 49% reported that an administrator pre-entered it into an EMR, but 43% reported that staff manually enter it into an EMR. About 55% of practices entered the information before vaccine administration, and 42% entered it afterward. Although 57% of respondents’ practices upload the vaccination information directly from the EMR to their state’s Immunization Information System (IIS), 30% must enter it both into the EMR and into the state IIS separately, and 11% don’t enter it into a state IIS.
More than half (56%) of the respondents were extremely interested in having a bar code scanner system, and 31% were moderately to strongly interested, rating a 6 to 9 on a scale of 1 to 10. If provided evidence that 2D bar codes reduced errors in vaccine documentation, 56% of respondents said it would greatly increase their interest, and 32% said it would somewhat increase it. Only 23% said their interest would greatly increase if the bar code technology allowed the vaccine information statement to be scanned into EMRs.
Nearly all the respondents agreed that 2D bar code scanning technology would improve efficiency and accuracy of entering vaccine information into medical records and tracking vaccine inventory. Further, 81% believed it would reduce medical malpractice liability, and 85% believed it would reduce risk of harm to patients. However, 23% thought bar code technology would disrupt office work flow, and a quarter believed the technology’s costs would exceeds its benefits.
Despite the strong interest overall, respondents reported a number of barriers to adopting 2D bar code technology. The greatest barrier, reported by more than 70%, was the upfront cost of purchasing software for the EMR interface, followed by the cost of the bar code scanners. Other barriers, reported by 25%-45% of respondents, were the need for staff training, the need to service and maintain electronics for the technology, and the purchase of additional computers for scanner sites. If a bar code system cost less than $5,000, then 80% of the respondents would definitely or probably adopt such a system. Few would adopt it if the system cost $10,000 or more, but 42% probably would if it cost between $5,000 and $9,999. Even this small survey of self-selected volunteers, however, suggested strong interest in using 2D bar code technology for vaccines – although initial costs for a system presented a significant barrier to most practices.
One influenza vaccine clinic’s experience
Interest based on hypothetical questions is one thing. The process of actually implementing a 2D bar code scanning system into a health care center is another. In a separate presentation, Jane Glaser, MSN, RN, executive director of Campbell County Public Health in Gillette, Wyo., reviewed how such a system was implemented for mass influenza vaccination.
Campbell County, in the northeast corner of Wyoming, covers more than 4,800 square miles, has a population base of nearly 50,000 people, and also serves individuals from Montana, South Dakota, and North Dakota. Although the community as a whole works 24/7 in the county because of the oil, mining, and farming industries, the mass flu clinic is open 7 a.m. to 7 p.m., during which it provides an estimated 700 to 1,500 flu vaccines daily. Personnel comprises 13 public health nurses, 5 administrative assistants, and 3-4 community volunteers.
After 20 years of using an IIS, the clinic’s leadership decided to begin using 2D bar code scanners in October 2011 after observing it at a state immunization conference. Their goals in changing systems were to increase clinic flow, decrease registration time, and decrease overtime due to data entry. The new work flow went as follows: Those with Wyoming driver licenses or state ID cards have the linear bar code on their ID scanned in the immunization registry, which automatically populates the patient’s record. Then the staff member enters the vaccine information directly into the IIS registry in real time after the client receives the vaccine.
Ms. Glaser describes a number of improvements that resulted from use of the bar code scanning system, starting with reduced time for clinic registration and improved clinic flow. They also found that using bar code scanning reduced manual entry errors and improved the efficiency of assessing vaccination status and needed vaccines. Entering data in real time at point of care reduced time spent on data entry later on, thereby leading to a decrease in overtime and subsequent cost savings.
For providers and practices interested in learning more about 2D bar coding, the CDC offers a current list of 2D bar coded vaccines, data from the pilot program, training materials, and AAP guidance about 2D bar code use.
None of three presentations noted external funding, and all the researchers reported no financial relationships with companies that profit from bar code scanning technology. Deloitte Consulting, was involved in the three-part project conducted by the CDC.
ATLANTA – Since the first bar coded consumer product, a pack of gum, was scanned in June of 1974, the soon widespread use of bar codes changed little until 2D bar codes arrived toward the end of last century. Today, the increasing use of 2D bar code technology with vaccines offers practices the potential for greater accuracy and efficiency with vaccine administration and data entry – if they have the resources to take the plunge.
An overview of 2D bar code use with vaccines, presented at a conference sponsored by the Centers for Disease Control and Prevention, provided a glimpse into both the types of changes practices might see with adoption of the technology and the way some clinics have made the transition.
Ken Gerlach, MPH, of the Immunization Services Division at the CDC in Atlanta, outlined the history of bar code use in immunizations, starting with a November 1999 Institute of Medicine report that identified the contribution of human error to disease and led the Food and Drug Administration to begin requiring linear bar codes on pharmaceutical unit-of-use products to reduce errors.
Then, a meeting organized by the American Academy of Pediatrics in January 2009 with the FDA, CDC, vaccine manufacturers, and other stakeholders led to a bar code rule change by the FDA in August 2011 that allowed alternatives to the traditional linear bar codes on vaccine vials and syringes.
“They essentially indicated to the pharmaceutical companies that it’s okay to add 2D bar codes, and this is essentially the point where things began to take off,” Mr. Gerlach explained. Until then, there had been no 2D bar codes on vaccines, but today the majority of vaccine products have them, as do all Vaccine Information Statements. In addition to the standard information included on traditional bar codes – Global Trade Item Number (GTIN), lot and serial numbers, and the expiration date – 2D bar codes also can include most relevant patient information that would go into the EMR except the injection site and immunization route. But a practice cannot simply jump over to scanning the 2D bar codes without ensuring that its EMR system is configured to accept the scanning.
Mr. Gerlach described a three-part project by the CDC, from 2011 through 2017, that assesses the impact of 2D coding on vaccination data quality and work flow, facilitates the adoption of 2D bar code scanning in health care practices, and then assesses the potential for expanding 2D bar code use in a large health care system. The first part of the project, which ran from 2011 to 2014, involved two vaccine manufacturers and 217 health care practices with more than 1.4 million de-identified vaccination records, 18.1% of which had been 2D bar coded.
Analysis of data quality from that pilot revealed an 8% increase in the correctness of lot numbers and 11% increase for expiration dates, with a time savings of 3.4 seconds per vaccine administration. Among the 116 staff users who completed surveys, 86% agreed that 2D bar coding improves accuracy and completeness, and 60% agreed it was easy to integrate the bar coding into their usual data recording process.
The pilot revealed challenges as well, however: not all individuals units of vaccines were 2D bar coded, users did not always consistently scan the bar codes, and some bar codes were difficult to read, such as one that was brown and wouldn’t scan. Another obstacle was having different lot numbers on the unit of use versus the unit of sale with 10% of the vaccines. Further, because inventory management typically involves unit of sale, it does not always match well with scanning unit of use.
Clinicians’ beliefs and attitudes toward 2D bar coding
As more practices consider adopting the technology, buy-in will important. At the conference, Sharon Humiston, MD, and Jill Hernandez, MPH, of Children’s Mercy Hospital in Kansas City, Mo., shared the findings of an online questionnaire about 2D bar coding and practices’ current systems for vaccine inventory and recording patient immunization information. The researchers distributed the questionnaire link to various AAP sections and committees in listservs and emails. Those eligible to complete the 15-minute survey were primary care personnel who used EMRs but not 2D bar code scanning for vaccines. They also needed to be key decision makers in the process of purchasing technology for the practice, and their practice needed to be enrolled in the Vaccines for Children program.
Among the 77 respondents who met all the inclusion criteria (61% of all who started the survey), 1 in 5 were private practices with one or two physicians, just over a third (36%) were private practices with more than two physicians, and a quarter were multispecialty group practices. Overall, respondents administered an average 116 doses of DTaP and 50 doses of Tdap each month.
Protocols for immunization management varied considerably across the respondents. For recording vaccine information, 49% reported that an administrator pre-entered it into an EMR, but 43% reported that staff manually enter it into an EMR. About 55% of practices entered the information before vaccine administration, and 42% entered it afterward. Although 57% of respondents’ practices upload the vaccination information directly from the EMR to their state’s Immunization Information System (IIS), 30% must enter it both into the EMR and into the state IIS separately, and 11% don’t enter it into a state IIS.
More than half (56%) of the respondents were extremely interested in having a bar code scanner system, and 31% were moderately to strongly interested, rating a 6 to 9 on a scale of 1 to 10. If provided evidence that 2D bar codes reduced errors in vaccine documentation, 56% of respondents said it would greatly increase their interest, and 32% said it would somewhat increase it. Only 23% said their interest would greatly increase if the bar code technology allowed the vaccine information statement to be scanned into EMRs.
Nearly all the respondents agreed that 2D bar code scanning technology would improve efficiency and accuracy of entering vaccine information into medical records and tracking vaccine inventory. Further, 81% believed it would reduce medical malpractice liability, and 85% believed it would reduce risk of harm to patients. However, 23% thought bar code technology would disrupt office work flow, and a quarter believed the technology’s costs would exceeds its benefits.
Despite the strong interest overall, respondents reported a number of barriers to adopting 2D bar code technology. The greatest barrier, reported by more than 70%, was the upfront cost of purchasing software for the EMR interface, followed by the cost of the bar code scanners. Other barriers, reported by 25%-45% of respondents, were the need for staff training, the need to service and maintain electronics for the technology, and the purchase of additional computers for scanner sites. If a bar code system cost less than $5,000, then 80% of the respondents would definitely or probably adopt such a system. Few would adopt it if the system cost $10,000 or more, but 42% probably would if it cost between $5,000 and $9,999. Even this small survey of self-selected volunteers, however, suggested strong interest in using 2D bar code technology for vaccines – although initial costs for a system presented a significant barrier to most practices.
One influenza vaccine clinic’s experience
Interest based on hypothetical questions is one thing. The process of actually implementing a 2D bar code scanning system into a health care center is another. In a separate presentation, Jane Glaser, MSN, RN, executive director of Campbell County Public Health in Gillette, Wyo., reviewed how such a system was implemented for mass influenza vaccination.
Campbell County, in the northeast corner of Wyoming, covers more than 4,800 square miles, has a population base of nearly 50,000 people, and also serves individuals from Montana, South Dakota, and North Dakota. Although the community as a whole works 24/7 in the county because of the oil, mining, and farming industries, the mass flu clinic is open 7 a.m. to 7 p.m., during which it provides an estimated 700 to 1,500 flu vaccines daily. Personnel comprises 13 public health nurses, 5 administrative assistants, and 3-4 community volunteers.
After 20 years of using an IIS, the clinic’s leadership decided to begin using 2D bar code scanners in October 2011 after observing it at a state immunization conference. Their goals in changing systems were to increase clinic flow, decrease registration time, and decrease overtime due to data entry. The new work flow went as follows: Those with Wyoming driver licenses or state ID cards have the linear bar code on their ID scanned in the immunization registry, which automatically populates the patient’s record. Then the staff member enters the vaccine information directly into the IIS registry in real time after the client receives the vaccine.
Ms. Glaser describes a number of improvements that resulted from use of the bar code scanning system, starting with reduced time for clinic registration and improved clinic flow. They also found that using bar code scanning reduced manual entry errors and improved the efficiency of assessing vaccination status and needed vaccines. Entering data in real time at point of care reduced time spent on data entry later on, thereby leading to a decrease in overtime and subsequent cost savings.
For providers and practices interested in learning more about 2D bar coding, the CDC offers a current list of 2D bar coded vaccines, data from the pilot program, training materials, and AAP guidance about 2D bar code use.
None of three presentations noted external funding, and all the researchers reported no financial relationships with companies that profit from bar code scanning technology. Deloitte Consulting, was involved in the three-part project conducted by the CDC.
ATLANTA – Since the first bar coded consumer product, a pack of gum, was scanned in June of 1974, the soon widespread use of bar codes changed little until 2D bar codes arrived toward the end of last century. Today, the increasing use of 2D bar code technology with vaccines offers practices the potential for greater accuracy and efficiency with vaccine administration and data entry – if they have the resources to take the plunge.
An overview of 2D bar code use with vaccines, presented at a conference sponsored by the Centers for Disease Control and Prevention, provided a glimpse into both the types of changes practices might see with adoption of the technology and the way some clinics have made the transition.
Ken Gerlach, MPH, of the Immunization Services Division at the CDC in Atlanta, outlined the history of bar code use in immunizations, starting with a November 1999 Institute of Medicine report that identified the contribution of human error to disease and led the Food and Drug Administration to begin requiring linear bar codes on pharmaceutical unit-of-use products to reduce errors.
Then, a meeting organized by the American Academy of Pediatrics in January 2009 with the FDA, CDC, vaccine manufacturers, and other stakeholders led to a bar code rule change by the FDA in August 2011 that allowed alternatives to the traditional linear bar codes on vaccine vials and syringes.
“They essentially indicated to the pharmaceutical companies that it’s okay to add 2D bar codes, and this is essentially the point where things began to take off,” Mr. Gerlach explained. Until then, there had been no 2D bar codes on vaccines, but today the majority of vaccine products have them, as do all Vaccine Information Statements. In addition to the standard information included on traditional bar codes – Global Trade Item Number (GTIN), lot and serial numbers, and the expiration date – 2D bar codes also can include most relevant patient information that would go into the EMR except the injection site and immunization route. But a practice cannot simply jump over to scanning the 2D bar codes without ensuring that its EMR system is configured to accept the scanning.
Mr. Gerlach described a three-part project by the CDC, from 2011 through 2017, that assesses the impact of 2D coding on vaccination data quality and work flow, facilitates the adoption of 2D bar code scanning in health care practices, and then assesses the potential for expanding 2D bar code use in a large health care system. The first part of the project, which ran from 2011 to 2014, involved two vaccine manufacturers and 217 health care practices with more than 1.4 million de-identified vaccination records, 18.1% of which had been 2D bar coded.
Analysis of data quality from that pilot revealed an 8% increase in the correctness of lot numbers and 11% increase for expiration dates, with a time savings of 3.4 seconds per vaccine administration. Among the 116 staff users who completed surveys, 86% agreed that 2D bar coding improves accuracy and completeness, and 60% agreed it was easy to integrate the bar coding into their usual data recording process.
The pilot revealed challenges as well, however: not all individuals units of vaccines were 2D bar coded, users did not always consistently scan the bar codes, and some bar codes were difficult to read, such as one that was brown and wouldn’t scan. Another obstacle was having different lot numbers on the unit of use versus the unit of sale with 10% of the vaccines. Further, because inventory management typically involves unit of sale, it does not always match well with scanning unit of use.
Clinicians’ beliefs and attitudes toward 2D bar coding
As more practices consider adopting the technology, buy-in will important. At the conference, Sharon Humiston, MD, and Jill Hernandez, MPH, of Children’s Mercy Hospital in Kansas City, Mo., shared the findings of an online questionnaire about 2D bar coding and practices’ current systems for vaccine inventory and recording patient immunization information. The researchers distributed the questionnaire link to various AAP sections and committees in listservs and emails. Those eligible to complete the 15-minute survey were primary care personnel who used EMRs but not 2D bar code scanning for vaccines. They also needed to be key decision makers in the process of purchasing technology for the practice, and their practice needed to be enrolled in the Vaccines for Children program.
Among the 77 respondents who met all the inclusion criteria (61% of all who started the survey), 1 in 5 were private practices with one or two physicians, just over a third (36%) were private practices with more than two physicians, and a quarter were multispecialty group practices. Overall, respondents administered an average 116 doses of DTaP and 50 doses of Tdap each month.
Protocols for immunization management varied considerably across the respondents. For recording vaccine information, 49% reported that an administrator pre-entered it into an EMR, but 43% reported that staff manually enter it into an EMR. About 55% of practices entered the information before vaccine administration, and 42% entered it afterward. Although 57% of respondents’ practices upload the vaccination information directly from the EMR to their state’s Immunization Information System (IIS), 30% must enter it both into the EMR and into the state IIS separately, and 11% don’t enter it into a state IIS.
More than half (56%) of the respondents were extremely interested in having a bar code scanner system, and 31% were moderately to strongly interested, rating a 6 to 9 on a scale of 1 to 10. If provided evidence that 2D bar codes reduced errors in vaccine documentation, 56% of respondents said it would greatly increase their interest, and 32% said it would somewhat increase it. Only 23% said their interest would greatly increase if the bar code technology allowed the vaccine information statement to be scanned into EMRs.
Nearly all the respondents agreed that 2D bar code scanning technology would improve efficiency and accuracy of entering vaccine information into medical records and tracking vaccine inventory. Further, 81% believed it would reduce medical malpractice liability, and 85% believed it would reduce risk of harm to patients. However, 23% thought bar code technology would disrupt office work flow, and a quarter believed the technology’s costs would exceeds its benefits.
Despite the strong interest overall, respondents reported a number of barriers to adopting 2D bar code technology. The greatest barrier, reported by more than 70%, was the upfront cost of purchasing software for the EMR interface, followed by the cost of the bar code scanners. Other barriers, reported by 25%-45% of respondents, were the need for staff training, the need to service and maintain electronics for the technology, and the purchase of additional computers for scanner sites. If a bar code system cost less than $5,000, then 80% of the respondents would definitely or probably adopt such a system. Few would adopt it if the system cost $10,000 or more, but 42% probably would if it cost between $5,000 and $9,999. Even this small survey of self-selected volunteers, however, suggested strong interest in using 2D bar code technology for vaccines – although initial costs for a system presented a significant barrier to most practices.
One influenza vaccine clinic’s experience
Interest based on hypothetical questions is one thing. The process of actually implementing a 2D bar code scanning system into a health care center is another. In a separate presentation, Jane Glaser, MSN, RN, executive director of Campbell County Public Health in Gillette, Wyo., reviewed how such a system was implemented for mass influenza vaccination.
Campbell County, in the northeast corner of Wyoming, covers more than 4,800 square miles, has a population base of nearly 50,000 people, and also serves individuals from Montana, South Dakota, and North Dakota. Although the community as a whole works 24/7 in the county because of the oil, mining, and farming industries, the mass flu clinic is open 7 a.m. to 7 p.m., during which it provides an estimated 700 to 1,500 flu vaccines daily. Personnel comprises 13 public health nurses, 5 administrative assistants, and 3-4 community volunteers.
After 20 years of using an IIS, the clinic’s leadership decided to begin using 2D bar code scanners in October 2011 after observing it at a state immunization conference. Their goals in changing systems were to increase clinic flow, decrease registration time, and decrease overtime due to data entry. The new work flow went as follows: Those with Wyoming driver licenses or state ID cards have the linear bar code on their ID scanned in the immunization registry, which automatically populates the patient’s record. Then the staff member enters the vaccine information directly into the IIS registry in real time after the client receives the vaccine.
Ms. Glaser describes a number of improvements that resulted from use of the bar code scanning system, starting with reduced time for clinic registration and improved clinic flow. They also found that using bar code scanning reduced manual entry errors and improved the efficiency of assessing vaccination status and needed vaccines. Entering data in real time at point of care reduced time spent on data entry later on, thereby leading to a decrease in overtime and subsequent cost savings.
For providers and practices interested in learning more about 2D bar coding, the CDC offers a current list of 2D bar coded vaccines, data from the pilot program, training materials, and AAP guidance about 2D bar code use.
None of three presentations noted external funding, and all the researchers reported no financial relationships with companies that profit from bar code scanning technology. Deloitte Consulting, was involved in the three-part project conducted by the CDC.
EXPERT ANALYSIS FROM AAP 16
Key clinical point: 2D bar coding with vaccines offers benefits and challenges.
Major finding:
Data source: A CDC study, an online questionnaire, and experience in a Wyoming flu clinic.
Disclosures: None of three presentations noted external funding, and all researchers reported no financial relationships with companies that profit from bar code scanning technology. Deloitte Consulting was involved in the three-part project conducted by the CDC.