Context In July 1999, due to concerns about thimerosal content, the American
Academy of Pediatrics (AAP) and the Public Health Service (PHS) recommended
suspending hepatitis B virus (HBV) vaccination at birth except for mothers
who had positive or unknown hepatitis B surface antigen (HBsAg) status. In
September 1999, the Centers for Disease Control and Prevention recommended
that hospitals resume HBV vaccination at birth with a new thimerosal-free
vaccine. Whether the 2 changes in recommendations within 3 months led to less-than-optimal
compliance in hospital nurseries is unknown.
Objective To determine hospital HBV vaccination policy before the recommendation
for delay of HBV vaccination and 1 year later.
Design, Setting, and Participants Survey of all 46 hospitals with obstetric services and neonatal nurseries
in Cook County, Illinois.
Main Outcome Measures Hepatitis B virus immunization practices before July 1999 and in August
2000; hospital factors associated with routine HBV immunization and compliance
with AAP and PHS recommendations.
Results Before July 1999, 74% of surveyed hospital nurseries offered HBV vaccine
to all neonates; only 39% did so in August 2000. Being located in the Chicago
city limits (88% vs 57%; P = .02) and having an academic
affiliation (93% vs 66%; P = .05) were positively
associated with routine neonatal immunization before July 1999. Both academic
affiliation and city location were associated with routine immunization in
August 2000 (71% vs 25% [P = .003] and 60% vs 14%
[P = .002], respectively) and with compliance with
recommendations for suspension (57% vs 25% [P = .03]
and 56% vs 10% [P = .001]).
Conclusions We documented a 35% decrease in hospital nurseries that routinely offered
HBV immunization 1 year after the AAP and PHS recommendations were made. Special
efforts may be required to make at-birth administration of HBV vaccination
The Advisory Committee for Immunization Practices (ACIP) and the American
Academy of Pediatrics (AAP) recommended universal vaccination of infants with
hepatitis B virus (HBV) vaccine in November 1991 (Table 1),1,2 and subsequently
the 3-dose series became well integrated into the schedule of childhood vaccines.3,4 A unique feature of the HBV vaccination
series, administration of the first dose at birth, has been desirable for
2 reasons: it substantially decreases the risk of vertical transmission in
mothers who are positive for hepatitis B surface antigen (HBsAg), or whose
HBsAg status is unknown,5 and it has also been
associated with on-time receipt of the HBV series and other childhood vaccines.3,4 Infants living in public housing in
Chicago who received the first dose of HBV vaccine soon after birth were more
likely to complete the HBV vaccine series by 19 months of age, to receive
the first DTP vaccine dose on time, and to complete the 4:3:1 series by age
19 months.3 The National Immunization Survey,
a nationwide random-digit dialing telephone survey, confirmed that children
who received the first dose of HBV vaccine at birth were more likely to have
completed the series vs those who received the first HBV vaccine dose later.4
On July 7, 1999, the AAP and Public Health Service (PHS) jointly recommended
a delay in initiation of the HBV vaccine series in infants until age 2 to
6 months, except for infants whose mothers had a positive or unknown HBsAg
status (Table 1).6
This was communicated to the membership by an "AAP Member Alert"7
direct mailing. Another statement for clinicians was published in the journal Pediatrics.8 This recommendation
was made because of a theoretical concern that thimerosal, an ethyl-mercury
preservative in HBV vaccine preparations, might potentially have a toxic effect
in the central nervous system.9 It was presumed
that delaying the first dose until infants were heavier would result in a
smaller mercury exposure for weight and therefore decrease the potential toxic
effect, and the HBV vaccination schedule already allowed for series initiation
through age 2 months to infants born to HBsAg-negative mothers, thereby the
impact of this recommended delay would be minimized.6
On September 10, 1999, the Centers for Disease Control and Prevention
(CDC), in the Morbidity and Mortality Weekly Report,
announced the availability of a thimerosal-free HBV vaccine and recommended
that routine HBV vaccination policies for all newborns should resume "in hospitals
in which these policies and practices have been discontinued."10
From September 1999 to July 2000, 5 notices regarding the availability of
a thimerosal-free HBV vaccine and recommendation for resumption of routine
hospital HBV vaccination policies for all newborns were issued by the CDC,
the Chicago Department of Public Health, the Cook County Department of Public
Health, and the AAP (Table 1).11-15
Because 2 changes were made in the HBV immunization recommendations
within 3 months, compliance required hospital nurseries to change policies
rapidly. We hypothesized, therefore, that there might have been confusion
about the desirability for administration of the HBV vaccine to newborns.
We surveyed hospitals in Cook County, Illinois, to determine how the AAP and
PHS recommendations affected HBV vaccination practices in newborn nurseries.
We designed a survey about HBV vaccination policy that focused on 3
questions: What was the newborn HBV vaccination policy before July 1999? Did
HBV immunization policy change during or after the summer of 1999? And what
was the HBV immunization policy a year later (August 2000) after thimerosal-free
vaccine became available?
The survey was directed to all general-care nurseries in Cook County
that provided obstetric services and routine medical care to healthy, full-term
infants. We selected hospitals from The American Hospital
Association Guide to the Healthcare Field.16
Intensive care nurseries were not included in the sample because HBV vaccine
is not recommended for premature infants born to HBsAg-negative mothers until
the infants reach a weight of 2000 g. In August and September 2000, we telephoned
the medical directors of the newborn nursery for each hospital. If the medical
director was not available, we spoke with the nursing director or another
physician whose primary role was providing care in the nursery. In addition
to HBV immunization policy, we asked about characteristics of the nursery;
who sets immunization policy in the hospital, consent procedures, and refusal
rates for HBV immunization; and whether information was routinely given to
parents about HBV vaccine. For survey purposes, policy referred to either
written policy or generally observed practices that determined HBV vaccination
of newborns. Using the same guide,16 we determined
suburban or Chicago location and hospital membership in the Council of Teaching
Hospitals and Health Systems (COTH), a component of the Association of American
Medical Colleges, with membership limited to hospitals affiliated with an
accredited medical school that participate in 4 or more approved active residency
programs.17 We linked 2 indexes of hospital
characteristics from the Health Care Financing Administration (HCFA) Payment
Impact File: case-mix adjustment and disproportionate-share adjustment.18 Case-mix adjustment is an algorithm that predicts
patients' hospital costs and is used to infer the acuity and complexity of
patients. A higher case-mix adjustment indicates sicker patients. Disproportionate-share
adjustment uses the proportion of Medicare patient days for which Medicaid
is the primary payer to estimate patients' socioeconomic status, with a higher
index referring to patients of lower economic status.
The analysis of survey responses focused on HBV immunization policy
before July 1999 and in August 2000. We examined which factors were associated
with routine HBV immunization. Using a χ2 test, we examined
whether there was a significant association between routine newborn HBV immunization
and hospital location, deliveries per month, and membership in COTH and whether
policy was set by individual or committee. We compared mean births per month,
mean case-mix index, and mean disproportionate-share index using t tests. Then we grouped hospitals into those that conformed with ACIP
or CDC preferred HBV vaccine schedule by (1) offering routine HBV immunization
at birth before July 1999, (2) suspending birth dose immunization (except
for infants born to mothers who had a positive or unknown HBsAg status) during
the summer of 1999, and (3) resuming routine immunization by August 2000.
We also examined which hospital factors predicted compliance. We collected
qualitative data from a subset of hospitals that did not follow the recommendations
to determine the reason for their decision. STATA 6 (Stata Corp, College Station,
Tex) was used for the analysis. The protocol was approved by the University
of Chicago institutional review board.
We identified 46 hospitals with obstetric services and newborn nurseries
in Cook County. We achieved a 100% response rate. Hospital and nursery characteristics
are summarized in Table 2.
Four HBV immunization policies for newborns were identified: (1) routine
immunization of all infants independent of maternal HBV status; (2) immunization
only when indicated by maternal HBV status (HBsAg positive or unknown status);
(3) immunization only when indicated by maternal HBV status and otherwise
at physician's discretion; and (4) immunization only when indicated by maternal
HBV status and otherwise if the patient had private health insurance.
Before July 1999, 74% of hospital nurseries offered routine HBV immunization
of all newborns (Table 3). These
institutions accounted for about 77% of Cook County births. The other 26%
of hospital nurseries determined HBV immunization of newborns by 1 of the
selective criteria (Table 3).
Policy of offering routine immunization differed according to city or suburban
location and by COTH membership. However, hospitals with a policy of routine
immunization before July 1999 did not differ from other hospitals in terms
of number of deliveries per month, who set vaccine policy, case-mix adjustment,
and disproportionate-share index (Table
In August 2000, only 39% of hospital nurseries were adhering to the
practice of offering routine HBV immunization of all newborns (Table 3). These institutions accounted for about 43% of Cook County
births. The other 61% of hospital nurseries determined HBV immunization of
newborns by 1 of the selective criteria (Table 3). Policy of offering routine immunization differed according
to city or suburban location and by COTH membership. Among the 32 non-COTH
hospitals, 60% in the city and 18% in the suburbs practiced routine immunization
(χ2 = 6.1, P = .01). A policy of routine
immunization in August 2000 did not differ according to number of deliveries
per month, who set vaccine policy, case-mix adjustment, or disproportionate-share
index (Table 4).
Following the July 1999 AAP and PHS recommendation, the HBV vaccine
birth-dose policy was changed in 40 of the 46 surveyed nurseries (87%). All
nurseries that discontinued routine HBV immunization adopted a policy of administering
HBV vaccine only when the infant's mother had a positive or unknown HBsAg
status. Of the 13% of nurseries that did not change their HBV vaccination
policy in July 1999, 1 nursery continued routine infant immunization and the
other 5 nurseries who previously maintained a policy of giving HBV vaccine
only when indicated by maternal HBV status continued that policy.
Of the 40 nurseries that changed policy after July 1999, 26 (65%) made
a second policy change before August 2000. Seventeen (65%) of these nurseries
resumed routine vaccination with thimerosal-free vaccine. In 8 (31%) of the
26 nurseries, the decision to vaccinate newborns was left up to individual
physicians. One nursery resumed a policy of routine HBV vaccination but only
for infants with private medical insurance.
The policy change to suspend was implemented rapidly: 16 of the 17 that
suspended routine HBV birth dosing did so in July 1999, and the other suspended
this policy in September 1999. In contrast, resumption of the HBV vaccine
birth dose after September 1999 was much slower: 3 nurseries resumed birth
dose administration in October, 1 in November, 2 in December, 5 in January
2000, 1 in March 2000, 4 in May 2000, and 1 in June 2000. There was no significant
relationship between duration of suspension in nurseries in which 1 person
determined vaccine policy vs nurseries in which a committee set the policy.
None of the 17 nurseries that offered universal HBV vaccination to newborns
before July 1999 and had not resumed this practice by August 2000 expressed
an intention to do so.
At the time of the survey, all nursery interviewees were aware of the
AAP and PHS recommendation to delay the birth dose of HBV vaccine, and all
but 1 were aware of the subsequent availability of thimerosal-free HBV vaccine.
Thirty-five percent of the nurseries followed all relevant HBV immunization
recommendations, ie, offering routine HBV immunization to all newborns before
July 1999, suspending the birth dose except for infants born to mothers who
had a positive or unknown HBsAg status during the summer of 1999, and resuming
routine HBV immunization by August 2000. When we compared the 16 nurseries
that had followed the preferred policy with those nurseries that did not,
we found membership in COTH and location in Chicago to be significant predictors.
Number of deliveries per month, who set vaccine policy, case-mix index, and
disproportionate share index were not associated with whether a nursery followed
the recommendations (Table 5).
We collected qualitative data about HBV vaccine policy from the 1 nursery
that did not suspend routine infant HBV immunization and 8 that suspended
but did not resume. The medical director of the nursery that did not suspend
routine immunization believed the benefit of giving routine HBV vaccination
at birth was greater than the theoretical risk of harmful effects from thimerosal.
Eight nurseries that did not resume gave 1 or more of the following reasons:
the cost of administering the vaccine in the nursery (n = 3), the belief that
physicians had begun to prefer initiating the HBV series at age 2 months (n
= 4), concern that there could be liability associated with giving HBV vaccine
to newborns (n = 1), and belief that routine HBV vaccination of infants was
not necessary (n = 1).
Obtaining parental consent for the vaccine was the policy in 93% of
nurseries. Seventy-seven percent of nurseries obtained written consent and
15% obtained verbal consent. Giving written documentation of the date of HBV
vaccine administration was the policy in 90% of nurseries, and 70% had a policy
to provide both written documentation of the date of vaccine administration
and information about the vaccine. It was the interviewees' belief that most
parents accept HBV vaccination for their newborns when offered. Ninety-six
percent of interviewees estimated the refusal rate at 10% or less, and 85%
estimated a refusal rate of 1%.
We found that nearly half the hospitals in Cook County that offered
routine HBV immunization to newborns prior to July 1999 were not doing so
in August 2000. We identified 2 main patterns of immunization policy that
the nurseries followed: temporary suspension of universal immunization of
newborns after July 1999 with resumption by August 2000 and permanent suspension
of universal immunization of newborns after July 1999. Policy changes were
attributed to the recommendations made by the AAP and PHS in July 1999 to
suspend the newborn dose. This situation is expected to continue because hospitals
that were not implementing a birth-dose policy did not anticipate making further
changes in immunization policy.
The net decrease in hospitals offering routine vaccinations of newborns
has the potential for negative consequences.19
First, routine vaccination ensures that infants born to mothers inaccurately
believed to have a negative HBsAg status would still receive prophylaxis against
vertical transmission. The recommended prophylaxis of newborns born to HBsAg-positive
mothers consists of both HBV vaccine and hepatitis B immune globulin, but
the risk of transmission is decreased by 75% to 85% when HBV vaccine is used
alone.5,20 Anecdotal evidence
presented at a workshop on thimerosal safety conducted at the National Institutes
of Health in August 199921 indicated that confusion
in the practicing community had already led to deferment of HBV vaccination
in infants born to mothers who had a positive or unknown HBsAg status. In
a widely reported case, a Michigan infant born to an HBsAg-positive mother
believed to be hepatitis B negative did not receive an HBV vaccine until aged
2.5 months because the birth dose had been discontinued over concerns about
thimerosal.22 The infant died of acute hepatic
failure at age 3 months.
There are also secondary benefits of the birth dose that may be lost
as a result of the decrease in the proportion of neonates routinely immunized.
Delay in the receipt of the first HBV vaccine dose in the nursery has been
associated with delay in on-time completion of the HBV vaccine series3,4 and 4:3:1 vaccination series.3 In an inner-city population, on-time completion of
vaccinations is particularly desirable because of historically low on-time
immunization rates and high risk for HBV infection.
There was a significant difference in HBV policy between city and suburban
hospitals. Chicago hospitals were more likely to have practiced routine immunization
before July 1999 and also in August 2000. Although the reasons for this difference
are unknown, suburban hospitals may perceive that the prevalence of HBV infection
and risk factors for HBV infection, such as injection drug use and multiple
sex partners, occurs less frequently in the suburban setting. Although the
1998 HBV infection incidence rates were lower for suburban residents (1.8
per 100 000) compared with Chicago residents (4.1 per 100 000),23 HBV infection is present even in a suburban setting.
However, although geographic variation in hospitals routinely offering the
birth dose has been noted previously, this variation was found to be inconsistently
related to HBV prevalence.24,25
A significantly higher proportion of COTH member hospitals practiced
routine immunization of newborns in August 2000. This observation confirms
data from a survey of pediatricians in North Carolina soon after recommendations
for universal HBV vaccination were made26 that
demonstrated an association between pediatricians' employment in medical schools
or health departments and a belief that universal HBV vaccination was warranted.
Physicians in academic centers may have greater appreciation of the benefit
of infant immunization, a greater awareness of guidelines, or a greater propensity
to follow them. One might suppose that COTH member hospitals may serve populations
at greater risk of HBV infection or with poorer compliance with childhood
immunization recommendations after leaving the hospital. However, the case-mix
index and the disproportionate-share index do not provide evidence indicating
that recommendation-adherent hospitals served markedly different patient populations
than those that were not adherent.
Our data indicate that there was relatively poor compliance with the
CDC and AAP recommendations to resume HBV immunization for all newborns despite
relatively good compliance with the first recommendation to suspend. When
a recommendation is rapidly reversed, intensified efforts may be required
to promote adherence. In July 1999, the AAP mailed a PedComm alert7 to its members and published an interim report in
the journal Pediatrics8
detailing the recommendation to suspend routine newborn HBV vaccination. Similar
alerts were not issued regarding the need for resumption with thimerosal-free
vaccine. Rather an article in AAP News14
recommended resumption of HBV immunization at birth in June 2000. Given the
high rate of adherence to the recommendation for suspension that we found
in Cook County nurseries, the PedComm Alert may have conveyed an urgency that
sped dissemination to practitioners whereas the AAP News article months later conveyed a less urgent message.
A policy to discontinue a practice may be easier to implement than one
initiating a practice, especially if the recommendation to initiate follows
closely and requires purchase of a new vaccine formulation. When universal
HBV vaccination was first recommended,1,2
incorporation of vaccination into routine care lagged even though practitioners
indicated acceptance of the policy.27
A concern about liability associated with giving HBV vaccine at birth
may be contributing to the decision to discontinue routine vaccination. Data
from a nationwide survey have shown that 70% of practitioners that administered
vaccines did not believe they were protected from vaccine-related litigation,28 suggesting that physicians may consider liability
when determining their vaccine practices. Sudden concern about thimerosal
and the rush to implement new vaccine policy may have heightened anxiety of
practitioners and parents about vaccine safety and led to the perception that
liability would be associated with vaccine administration.
Economic factors may have led to abandonment of newborn vaccination
in some instances. Although reimbursement for vaccination is available from
public and private sources, representatives of several nurseries expressed
concern about the cost of resuming vaccination. There may be unrecoverable
costs associated with vaccination such as practitioner time required for education,
consent, and administration of the vaccine. Also, nurseries may consider unrecoverable
costs of vaccination to be greater than the benefits so that suspension was
a welcomed recommendation but resumption was not.
Three limitations of this study may affect interpretation of the findings.
First, we relied on self-reporting and recall for dates of policy implementation
and did not independently verify responses. Second, although Cook County has
a population of more than 5 million people and encompasses urban and suburban
areas, the data may reflect policies and determinants of policies unique to
this location. However, a mail survey in February 2000 in Wisconsin similarly
found many hospitals had not reinstated routine at-birth administration of
HBV vaccine after suspension because of thimerosal concerns.22
Third, the small sample size precludes fully distinguishing the effects of
COTH membership and urban or suburban location.
Special efforts may be necessary to make routine at-birth administration
of HBV vaccine universal. Community intervention consisting of educational
programs and cost compensation for vaccine administration have been effective
in improving the rate of HBV vaccine administration to newborns.29
The medical and public health benefits of initiating HBV vaccine in the nursery
seem to justify educational efforts aimed at restoring HBV vaccine administration
to newborns. It is noteworthy that our survey and others30
indicate almost all parents accept HBV vaccination for their newborn when
it is offered, suggesting that efforts to increase newborn HBV vaccination
rates should be aimed at health care practitioners. Adoption of universal
HBV vaccination for newborns will potentially eliminate a vaccine "missed
opportunity" and ensure high immunization rates against HBV and, possibly,
other immunizations recommended for routine administration.
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