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Vaccine presentation in the USA: Economics of prefilled syringes versus multidose vials for influenza vaccination

Authors:

Abstract

In the USA, influenza vaccines are available as parenteral injections or as an intranasal preparation. Injectable influenza vaccines are available in either multidose vial (MDV), single-dose vial or prefilled syringe (PFS) presentations. PFSs have gained market share in the USA but have not yet reached the levels of uptake currently seen in Western Europe. Here, we review the topic of vaccine presentation in the USA, with a special focus on influenza vaccines. Second, we present the results of a time-motion study that measured administration costs of influenza vaccination comparing MDVs versus PFSs during the 2009/2010 influenza campaign. Vaccinating with MDVs took an average 37.3 s longer than PFSs. The cost of administering 1000 immunizations in 2009 using MDVs were US$8596 versus US$8920.21 using PFSs. In a pandemic situation where 300 million Americans would require vaccination, PFSs would save 3.12 million h in healthcare worker time, worth US$111.1 million. The higher acquisition costs of PFS vaccines compared with MDVs are offset by lower administrative costs and increased safety.
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10.1586/ERV.10.129
Injectable influenza vaccination (this article
focuses only on injectables; intranasal influenza
vaccine [Flu-mist™] has an important role in
influenza vaccination but is not considered here)
in the USA is currently distributed in three main
presentations: vials, which can be single or multi-
dose (MDV), and prefilled syringes (PFSs). The
USA predominantly uses MDVs, but PFSs have
gained market share over the last few years [101].
We estimate that, currently, PFSs hold approxi-
mately 30% of the market for influenza vaccines.
Comparing the two influenza vaccine preparations
in terms of monetary acquisition, PFSs may cost
slightly more per dose than MDVs, but could offer
advantages in speed, disposal, wastage and patient
safety owing to premeasured accurate doses that
reduce dosing errors [1–3]. PFSs also reduce the
risk of microbial contamination, which can occur
from improper aseptic techniques. Vaccines in
PFSs do not contain the preservative thimerosal,
whereas MDV vaccines do. A drawback of PFSs
is a requirement for more storage space as they
can be heavily packaged by the manufacturer to
prevent damage. Bulkier packaging can increase
refrigeration costs. Production, shipment and stor-
age of MDVs are all cheaper, but using MDVs
can be more time consuming for the healthcare
worker, because each dose must be drawn from
the vial using a needle and an empty syringe, lead-
ing to higher administration costs. Using MDVs
adds operational complexity and more potential
for dosing errors and contamination.
The goal of this article is twofold. First, we
provide a descriptive overview of the current
literature on operational features of MDVs and
PFSs. Second, we report measurements com-
paring the efficiency and costs associated with
MDVs and PFSs for influenza vaccination dur-
ing the 2009/2010 influenza campaign. Our
measurements emerge from a time-motion study
of the influenza vaccination process at immuni-
zation clinics. Nurses’ activities related to MDVs
and PFSs were observed and timed using a stop
watch. All relevant usage costs associated with
PFSs and MDVs were identified and compared.
We also measured the amount of vaccine that
remained in vials after they were deemed empty
by the healthcare worker.
Claudia C Pereira1 and
David Bishai†1
1Department of Population Family and
Reproduc tive Health, Johns Hopkins
Bloomberg School of Public Health,
615 N. Wolfe Street, Suite 4622,
Baltimore,MD 21205, USA
Author for correspondence:
Tel.: +1 410 955 7807
Fax: +1 410 955 2303
dbishai@jhsph.edu
In the USA, influenza vaccines are available as parenteral injections or as an intranasal preparation.
Injectable influenza vaccines are available in either multidose vial (MDV), single-dose vial or
prefilled syringe (PFS) presentations. PFSs have gained market share in the USA but have not
yet reached the levels of uptake currently seen in Western Europe. Here, we review the topic of
vaccine presentation in the USA, with a special focus on influenza vaccines. Second, we present
the results of a time-motion study that measured administration costs of influenza vaccination
comparing MDVs versus PFSs during the 2009/2010 influenza campaign. Vaccinating with MDVs
took an average 37.3 s longer than PFSs. The cost of administering 1000 immunizations in 2009
using MDVs were US$8596 versus US$8920.21 using PFSs. In a pandemic situation where 300
million Americans would require vaccination, PFSs would save 3.12 million h in healthcare worker
time, worth US$111.1 million. The higher acquisition costs of PFS vaccines compared with MDVs
are offset by lower administrative costs and increased safety.
Keywor ds: costs • immunization • inuenza vaccine • multidose vials • prelled syringes • time motion
• vaccine administration
Vaccine presentation in the
USA: economics of prelled
syringes versus multidose vials
for influenza vaccination
Expert Rev. Vaccines 9(11), 1343–1349 (2010)
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Expert Rev. Vaccines 9(11), (2010)
1344
Review Pereira & Bishai
What is the current status of MDV & PFS use in
influenza vaccination the USA?
A variety of factors have led to a growing number of manufac-
turers of vaccines and other injectables offering PFS platforms
for their products. Over the last decade, the US market for PFSs
grew at a rate of approximately 20% per year [101]. For vaccines,
efficiency and perceived safety drive the growth of PFS presenta-
tions. Despite the lack of evidence of toxic effects of thimerosal,
the public perception of risk owing to this preservative has shifted
many providers away from MDVs towards preservative-free PFSs.
In 2004, the Institute of Medicine’s Immunization Safety Review
committee rejected any causal link between thimerosal and
autism [4]. Despite such information, many parents and patients
still exhibit concerns over the use of vaccines in general [5,6] , and
from MDVs in particular.
Efficiency
Influenza vaccines have traditionally been delivered in clinical
settings, but recent years have seen a shift towards more vaccines
being offered in workplaces, retail centers and at schools. In
all of these settings, efficiency and streamlining are extremely
important [7]. Patients with wavering interest in influenza vac-
cination and consumers are likely to be deterred by long waiting
times. Efficiency is especially important in mass vaccination
settings where the goal is to deliver vaccines as quickly as pos-
sible [8]. The success of mass influenza vaccination clinics relies
on the ability to offer rapid access to low-cost influenza vaccina-
tions in a safe and organized manner. This is particularly impor-
tant in the USA at present because the Advisory Committee
on Immunization Practices (ACIP), which advises the CDC
on vaccine use and policy, voted unanimously to recommend
universal seasonal influenza vaccination for all Americans aged
6 months and older, starting in the 2010/2011 season [9].
Prior studies comparing MDVs and PFSs have been conducted
in Canada, Japan and countries in Europe. A study conducted
by Scheifele and colleagues in Canada concluded that PFSs
could save nurses’ time in mass immunization clinics. Authors
noted that PFSs reduced nursing service time by 9–12 person-
hours per 1000 doses, depending on the PFS packaging (indi-
vidual or trays), thus reducing labor costs by 25–33% [2]. An
earlier study in 1996 conducted in European hospitals compared
prefilled disposable syringes with conventional vial-based sys-
tems for parenteral injections and demonstrated that PFSs led
to a cost reduction of 1.5 French Francs (or 1996 GB£0.15) per
injection [3]. A study conducted in a hospital in Japan demon-
strated that for PFSs, the operation time during the preparation
of vaccination was reduced by 31.7% in comparison with vial
preparations [1]. The authors emphasized that PFSs are especially
important in influenza vaccination, because vaccinations for
large numbers of people are concentrated into a few months
of the year. Safety and convenience become more critical with
high throughput vaccination. According to the Japanese study,
healthcare professionals in Japan are eager for further develop-
ment of PFSs for vaccines and medications not yet available and
support increased availability of the products currently available
in PFSs [1]. No published studies for the USA have addressed
efficiency in influenza vaccination, hence the rationale for the
study presented here.
Safety
Safety is a top concern in vaccination. Paradoxically, there is idio-
syncratic variation in the way vaccines are administered, reflecting
peculiarities in the way a task can be performed from practice
to practice. Although the CDC has issued guidelines for best
practices in vaccine administration [102 ,103], it is left to individual
practices to achieve guideline adherence. Unsafe injection-related
practices may not be recognized, but when observed should be
obvious and the magnitude of the consequences of unintended
deviant practices may not always be understood [10]. According to
research conducted at the CDC, improper handling of injectable
medications can lead to infections and other severe outcomes in
patients [104]. The research from the CDC presented at the Fifth
Decennial International Conference on Healthcare-Associated
Infections 2010 showed that nosocomial infections can result
from inadequate injection safety practices, and such events could
be prevented by safer practices. Some of the unsafe practices were
related to hygiene and improper storage and labeling. For instance,
the CDC identified as safety breaches the use of multidose medi-
cations that were accessed multiple times with nonsterile syringes
and needles [105].
The National Center for Immunization and Respiratory
Diseases (NCIRD) of the CDC strongly recommends that health-
care workers draw the vaccine only at the time of administration
to reduce errors and ensure that the cold chain is maintained and
that vaccine is not inappropriately exposed to light [106]. Problems
noted by the NCIRD in regard to the practice of drawing vac-
cine at times other than immediately prior to patient injection
(e.g., ‘predrawing’) include:
• Misidentification of the contents of an unlabeled syringe;
• Vaccine wastage;
• Bacterial contamination, especially of vaccines from single-dose
vials that do not contain bacteriostatic agents;
• Possible reductions in potency from interaction between the
plastic syringe and vaccine components;
• Inability of the person administering the dose to be sure of the
composition and sterility of the product.
One example of a medication-switch error happened in January
of 2010 in Massachusetts (USA) where several staff members at
an elementary school had to be taken to a hospital after being
injected with insulin rather than the H1N1 vaccine [107]. In addi-
tion, during observation of the clinics for this study, numerous
guidelines were not adhered to (further details of these obser-
vations are discussed in the results section). Better vaccine and
medication labeling, as well as the use of antigens that cannot be
predrawn in advance and left in refrigerators with no labeling,
would be key factors to counter such events. Furthermore, ade-
quate recording of lot numbers would ensure proper information
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Vaccine presentation in the USA
in the case of adverse events. Recording the correct lot number
in the medical record and/or in the patient vaccination card is a
task made easier by PFSs in comparison with MDVs because PFSs
have a detachable label in the package.
The results of a qualitative survey conducted at five European
hospitals showed that approximately 95% of participating hospi-
tal workers found PFSs more convenient to use and handle than
vials or ampoules, and that PFSs saved time during injections.
Furthermore, 67% found PFSs more convenient to discard. Other
aspects of PFSs that were highlighted by healthcare professionals
were: decreased risk of dosing errors, smaller risk of microorganism
transmission to the patient and lower risk of injuries for nurses [3].
The study by Hirayama and Kuroyama in Japan showed that PFSs
avoided wastage, made inventory control easier, lowered the risks
of nurses making a mistake and also enabled quicker responses in
emergency situations [1]. In summary, current literature indicates
that PFSs have the potential to be safer and more efficient than
vials. But there have been no studies from the USA to support a
systematic comparison. This was our rationale for studying the
time required to administer vaccines via vials versus PFSs.
Efficiency & costs: Baltimore study
Methods
The efficiency, costs and safety practices related to influenza
vaccination were evaluated in a time-motion study. Seven
practices in Baltimore (MD, USA) and the metropolitan area
participated in the study. The practices included hospitals,
clinics and private medical centers. The sites varied in their
location; three were urban and four suburban. Five practices
provided both seasonal and H1N1 influenza vaccines, whereas
two only provided the seasonal influenza vaccine. We observed
31 immunization professionals (Ta bl e 1) , all of whom were reg-
istered nurses with various years of experience, ranging from
3 to 39 years (mean: 18.1; SD: 11.7). The practices sampled
were selected based on their willingness to participate in the
study and permission was obtained from each healthcare pro-
vider to have their immunization-related activities observed and
timed. Observations and data collection took place between
October 2009 and March 2010.
Data collection
We collected time and cost data on all activities related to immu-
nization with MDVs and PFSs for both seasonal and H1N1
influenza vaccines. The time spent by immunization profession-
als on their vaccination-related activities was recorded using a
stopwatch. We observed tasks in the vaccine preparation process,
from the time of removal of the vial or the syringe package from
the refrigerator until the time it was ready to be administered to
a patient. Often during the observations it was not possible to
observe all tasks involved in one vaccine preparation process as a
whole, as there was no standardized way of executing the tasks.
For instance, sometimes nurses attached needles to syringes in
bulk, so they were readily available when needed. That may have
happened hours or days before they actually drew vaccine from
a vial, so that the observer was not able to observe that step, but
could observe the other steps of the sequence. We assumed that
the time to actually inject the patient would be the same for
both methods, so we did not measure the time it took to inject.
Our time measurements end from the moment the vaccine was
considered ready to inject.
Table 1. Characteristics of the sample of registered
nurses observed.
Registered
nurse ID
Years of
experience
SiteTimes observed
(n)§
1 37 2 80
2 7 2 69
3 28 2 23
4 8 2 42
5 23 2 90
6 6.5 3 1
7 5 3 2
8 7.5 3 17
9 6 3 47
10 39 3 12
11 17 3 13
12 7 3 7
13 3 3 19
14 15 3 34
15 31 3 5
16 30 3 2
17 12 3 25
18 23 3 7
19 37 3 8
20 9 4 7
21 23 4 3
22 11 1 10
23 8 1 6
24 25 1 1
25 27 1 5
26 9 1 6
27 34.5 1 3
28 30 1 2
29 10 1 4
30 31 5 4
31 3 5 1
Total = 555
Years of experience as a nurse.
Sites six and seven provided empty vials and participated in interviews about
prefilled syringes and multidose vials.
§Number of times a nurse was o bserved performing multiple tasks, w hich could
be the preparation of one or multiple vaccines to be administered.
Expert Rev. Vaccines 9(11), (2010)
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Cost measurement
Healthcare professionals’ salaries were obtained through the US
Bureau of Labor Statistics website, statistics for the year 2009 [11].
We utilized mean wages for registered nurses in the state of
Maryland, USA.
Monthly storage costs were estimated by obtaining the average
market price of medical-use refrigerators of 4 cubic feet capac-
ity, assuming a 10-year useful life and a discount rate of 5%.
Consumer price inflators were used to adjust prices for infla-
tion. The average volume for a package of five doses of PFSs was
52.6 cm3 and of ten doses of MDVs or one vial was 5.4 cm3.
Disposal/waste cost difference was assumed to be negligible, as
we pressumed that hospitals and clinics already have a contracted
waste service and the choice of MDVs or PFSs would not lead to
additional waste disposal collection visits.
The prices for syringes, needles, alcohol pads and gloves for
the brands and models we observed were obtained from the 2009
Red Book™ Drug Reference [12]. The prices for vaccines were
obtained from the IMS MIDAS database [108].
In order to account for uncertainty and to take into account
the relatively small number of practices we investigated, we per-
formed a set of one-way sensitivity analyses, using the lowest and
highest costs we identified in the 2009 Red Book for vaccines,
needles, gloves and alcohol. For storage we calculated the lower
bound by multiplying the smallest storage unit cost by 0.8, and
likewise we multiplied the largest storage cost for PFSs by 1.2.
In a similar fashion, for the lower bound of healthcare worker
wages, we multiplied the national average salary of a medical
assistant by 0.8. For the upper bound, we used the mean salary
for a registered nurse.
Statistical analyses: time use estimation
All analyses were made using STATA SE 10 [13]. The process to
prepare a vaccine for injection is composed of several individual
subtasks. Some subtasks were timed individually. Most were
timed as part of a continuum of sequential subtasks. Stop watch
episodes commonly represented more than one single subtask,
but the duration of each episode was always accompanied by
data on which subtasks had occurred in the inter val. In our
dataset we had up to seven subtasks represented in one single
time measurement. The dataset was arranged so that the length
of each measured episode was attached to a list of up to seven
subtasks that occurred during that interval. Getting a vaccine
ready from MDVs could take up to 16 subtasks and up to ten
for PFSs (F igur e 1).
To estimate time per subtask we used random-effects regres-
sion models to take into account the effects of healthcare profes-
sionals. The model assumed clinic-specific and worker-specific
random effects. We were able to estimate individual weighted
average times for each of the 21 subtasks that could possibly
be performed. From our observations and from the literature,
we listed all practice steps to vaccinate using MDVs and PFSs,
although sometimes none of these steps were performed by a
nurse. Finally, we estimated total time required to complete all
subtasks for either MDVs or PFSs. The coefficients in the models
were interpreted as the incremental number of seconds required
to conduct each corresponding subtask. After estimating the
average time required for each of the subtasks we observed, we
estimated the total time to conduct the entire sequence of sub-
tasks ( Figur e 1) . We conducted that separately for vial-only tasks
(13 tasks), common tasks for both MDVs and PFSs (six tasks)
and PFS-only tasks (five tasks).
Results
We observed a total of 555 multitasking activities performed
by 31 different registered nurses. We estimated that the total
time in seconds to get a vaccine ready to be administered per
patient was 87 s for MDVs and 49.71 s for PFSs, a difference of
37.29 s ( Figu re 1).
After adding all relevant administration costs, which included
nurses’ time, syringes for MDVs only, needles, storage, alcohol
and gloves per 1000 injections, the total administration costs
Remove vial from box 2.07
Unpack syringe 11.43
Split needle packs 1.77
Attach fill needle 4.20
Expose stopper 0.36
Sterilize vial 4.32
Fill/measure from vial 6.81
Unwrap new needle 2.27
Affix new needle 4.20
Uncap/cap/dispose 10.79
Write tracking number 1.49
Vial tasks (time [s])
Don gloves 0.87
Retrieve vaccine from fridge 1.25
Open box of needles 1.15
Split needle packs 1.77
Unwrap one needle 2.27
Tidy up 1.33
Common tasks (time [s])
Open PFS box (five or ten) 1.61
Remove tracking number 1.19
Attach PFS to needle 4.20
Uncap/dispose 5.42
Prefilled tasks (time [s])
Total: 49.71 s (A) Difference between MDVs and PFSs
(A–B) = 37.29 s
Total: 12.42 s (B)
Figure 1. Estimated time in seconds for tasks associated with multidose vial and prefilled syringe use.
MDV: Multidose vial; PFS: Prefilled syringe.
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Vaccine presentation in the USA
in 2009 were US$ 8596 for MDVs and US$8920.21 for PFSs, a
difference of US$324.21 (Ta ble 2) or US$0.32 per dose adminis-
tered. These numbers exclude the acquisition cost of the vaccine.
Our estimates thus suggest a ‘breakeven’ PFS price differential of
US$0.32. At this price, the savings in vaccination administration
costs would exactly offset the higher PFS purchase price.
We conducted a series of univariate sensitivity analyses to
explore the impact of varying all costs that were common to
MDVs and PFSs (Figure 2). Our results indicate that vaccine acqui-
sition price is the main source of uncertainty in the analyses. The
total administration costs varied from US$7456 to US$10,010
in 2009 dollars.
A number of clinical practice adaptations during vaccine
preparation were obser ved and documented. At times, for
instance, the same alcohol swab was repeatedly used to sterilize
the vial, without being exchanged or receiving more alcohol.
This was especially true when nurses were predrawing a batch
of vaccines at once in preparation for a big influenza clinic day,
so they had to act quickly. The observer
noted instances where nurses pooled vac-
cine remainders from multiple spent vials
in order to assemble a full dose, which
does not adhere to safe injection practices.
In many clinics, vaccines were predrawn
many hours in advance to expedite the vac-
cination process, especially in influenza clin-
ics that need to minimize patient waiting
time. With predrawing there was potential
confusion about vaccine lot number, since
there was no place on the syringe to write the
lot number. In instances of predrawing, we
frequently observed incorrect forecasts of the
number of vaccines that would be needed.
Leftover vaccines that were predrawn from
vials would remain in the plastic syringe for
the following day.
When vaccines were predrawn, nurses often relied on memory
for entering vaccine lot numbers in patient records. A very com-
mon practice was to memorize one relevant lot number for a
day or session and enter the memorized number on the patient’s
paperwork, without referencing the original packaging. Some
nurses wrote the vial lot numbers on pieces of paper that they
could later refer to and some even wrote the number on their
skin, as a way of being able to refer to it at any time. During one
session the lot number had changed between the syringes for that
session and a nurse was still writing the previous lot number.
Discussion
Although MDVs require less cold storage and may have lower
acquisition costs, their use imposes higher staff time burdens
and higher task complexity. Practices related to predrawing vac-
cine into unmarked plastic syringes were observed that could
impact patient safety and reduce vaccine potency. PFS packaging
makes them bulkier to store but none of the clinics observed
7000 7500 8000 8500 9000 9500 10,000 10,500 11,000 11,500
Vaccine price
Gloves price
Staff wage price
Needle price
Alcohol price
Storage price
US$
10.0107.456
7.654 8.547
8.557 9.393
8.466 9.300
8.590 8.926
8.596 8.909
Figure 2. Tornado diagram of univariate analyses. This tornado diagram shows the
degree to which uncertainty in prices affects estimates.
Table 2. Costs associated with vaccination using multidose vials and prefilled syringes in 2009 in the USA.
Resources for
1000 doses
MDVs PFSs
Units Price (US$) Total (US $) Units Price (US$) Total (US$)
Staff time (person h) 13.81 14.16/h195.55 3.45 14.16/h48.85
Syringe1000 0.39 /unit 390.00 NA NA NA
Needles2000 0.31/unit 310.00 1000 0.31/unit 310.00
Alcohol1000 0.03/unit 30.00 1000 0.03/unit 30.00
Gloves1000 0.08/unit 80.00 1000 0.08/unit 80.00
Vaccine1000 7.59/dose§7590.00 1000 8.44/dose§8440.00
Storage1000 doses/month 0.00045/unit 0.45 1000 doses /month 0.0114/unit 11.36
Total8596.00 8920.21
From the US Bureau of Labor Statistics for wages of a medical assistant [11].
From the 2009 Red Book™ [12].
§Average price – I MS MIDA S – Price differential is individually negotiated by distributors and dynamically changing in time.
The differences between PFSs and MDVs (per 1000 doses) is 324.21.
MDV: Multidose vial; N A: Not available; PFS: Prefilled syringe.
Expert Rev. Vaccines 9(11), (2010)
1348
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had cold storage constraints that would impede their ability to
use PFSs. By the same token, none of the clinics were at a point
where they could reduce tota l clinic staff if they could save
37.29 s per patient vaccinated based on the patient volumes the
days we observed.
Nevertheless, in the broad scheme of things, the 37.29-s gap
between MDVs and PFSs may have important implications.
Considering the American birth cohort of 4 million infants, with
each infant typically encountering approximately 15 shots before
1 year of age, the use of PFSs would save 621,500 person-hours
worth US$22.2 million in healthcare worker time in 1 year of
infant vaccination. In a pandemic situation where 300 million
Americans would require vaccination, PFSs would save 3.12 mil-
lion h, worth US$111.1 million in healthcare worker time. The
economic decision rests on whether there are better uses for the
precious resource of healthcare worker time, especially of nurses.
Conclusion
This work shows that the costs of vaccine administration using
PFSs are lower than using MDVs. These costs primarily reflect
the longer average time required to prepare a dose of vaccine
from a MDV.
Given the current US scenario and system of reimbursement
from health plans, the small price gap between MDVs and PFSs
and storage requirements are likely to be the main reasons that
practices have not yet completely switched to PFSs in the case
of influenza vaccines. Furthermore, from the perspective of the
clinics, those that receive most of their supplies through the
Vaccines for Children Program would benefit the most from the
time and convenience of PFSs compared with MDVs, as they
are not incurring the expense of the vaccines. Mass vaccination
clinics would need to weigh the relative convenience of PFSs in
relation to MDVs, versus the full cost of both.
There are strong indications that the growth of PFS penetra-
tion into the market for vaccines will continue as American con-
sumers and providers become more familiar with the advantages
of these products.
Expert commentary & five-year view
Influenza vaccination in the USA still predominantly uses MDVs,
but PFSs offer many advantages over MDVs in terms of efficiency
and safety, especially considering the many opportunities for errors
and contamination that the use of MDVs creates in vaccination.
Although there are unknown issues surrounding policy and
market strateg y related to influenza vaccines, we expect to con-
tinue to see growth in the market share of PFSs for influenza
vaccines in the USA. We anticipate that this market will grow
from the current 30 % to 80 85% in the next 5 years. Our
projection is based on interviews with important stakeholders
from this industry and from our understanding of the mar-
ket dynamics over the last few years. As the demand for PFSs
increases, manufacturers are expected to increase production
capacity and drive costs down. This has already been seen to
a certain extent in the past decade. We expect to see the price
gap between PFSs and MDVs diminish over the next 5 years.
Acknowledgments
The authors would like to thank the practices and nurses who kindly
allowed us to observe their work and routine. They also acknowledge the
helpful comments received from Brian Lynch, Nuphar Rozen-Adler,
Justin Wright and Jennifer Zolot.
Financial & competing interests disclosure
The study was funded by a grant from Becton, Dickinson & Company. The
authors have received a grant from Becton, Dickinson and Company. The
authors have no other relevant affiliations or financial involvement with
any organization or entity with a financial interest in or financial conflict
with the subject matter or materials discussed in the manuscript. This
includes employment, consultancies, honoraria, stock ownership or options,
expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
The authors state that the study received IRB exempt status from the Johns
Hopkins Bloomberg School of Public Health Internal Review Board. Even
though the IRB declared the study to be exempt, the investigators obtained
consent from each participant.
Key issues
Prefilled syringes (PFSs) have gained market share in the USA, growing at approximately 20% a year, but have not yet reached levels of
uptake currently seen in Western Europe.
In influenza vaccination, PFSs may cost more per dose than multidose vials (MDVs), but could offer advantages in speed, disposal, wastage
and patient safety owing to premeasured accurate doses that reduce dosing errors.
Efficiency and safety are the two key aspects for different stakeholders in influenza vaccination.
A time-motion study conducted in Baltimore, MD, USA during the 2009/2010 influenza vaccination campaign estimated that the total time
to get a vaccine ready to be administered per patient was 87 s for MDVs and 49.71 s for PFSs, a difference of 37.29 s.
The total administration costs for MDVs in 2009 were US$8596 and US$8920.21 for PFSs, a difference of US$324.21 per 1000 doses or
US$0.32 per each dose administered. These numbers exclude the acquisition cost of vaccination.
MDVs require less cold storage and may have lower acquisition costs, but their use imposes higher staff time burdens and higher task
complexity. Practices related to predrawing the vaccine into unmarked plastic syringes were observed that could impact patient safety and
reduce vaccine potency.
If we consider the American birth cohort of 4 million infants, with each infant typically encountering approximately 15 shots before 1 year of
age, the use of PFSs would save 621,500 person-hours, worth US$22.2 million in healthcare worker time in 1 year of infant vaccination.
In a pandemic situation, where 300 million Americans would require vaccination, PFSs would save 3.12 million h, worth US$111.1 million, in
healthcare worker time.
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Vaccine presentation in the USA
References
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syringeswithmultidosevials.
2 Scheifele DW, Skowronski D, King A et al..
Evaluation of ready-to-use and multi-dose
influenza vaccine formats in large clinical
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... Data from studies in different fields highlight that prefilled syringes can help improve the speed of infusion [37][38][39][40][41][42][43][44] and the number of dosing errors [37,45,46] when compared with infusions done using traditional ampoules. It should be noted that many of these studies were performed in the critical care field, where reducing infusion time and dosing errors is of key importance. ...
... The overall economic impact and cost-effectiveness of introducing prefilled syringes as a replacement for traditional vials has been evaluated in a variety of clinical settings (Table 4). Relative to drug administration with a traditional vial and syringe, prefilled syringes are typically associated with a higher cost per unit [41,42,56,57,62,63] (Table 4), which may lead to increased treatment costs. For example, in the setting of anesthesia, switching from standard ampoules to commercial ephedrine prefilled syringes was estimated to increase drug costs by over €50,000 annually in a retrospective, observational study in 32 operating theaters [57], and more than double weekly costs (£274.32 vs. £115.72/ ...
... Savings in nursing time were also cited as a main contributor to the 50-70% reduction in costs reported with the use of heparin prefilled syringes for the treatment of deep vein thrombosis relative to traditional IV infusion (£4.80 vs. £9.52-16.81/day) [38], and in large-scale vaccination programs (25-75% reduction in nursing cost) [41,42]. Finally, prefilled syringes may be associated with a reduction in medication errors and their associated costs. ...
Article
Full-text available
Introduction: Ready-to-use pre-filled syringes for drug delivery are increasingly used across a broad spectrum of clinical specialties. For patients with primary immunodeficiencies manifesting as antibody deficiencies, immunoglobulin G (IgG) replacement therapy (IgRT) by subcutaneous administration is an established treatment modality. Expanding IgRT administration options through the introduction of pre-filled syringes may further improve its utility. Areas covered: Here, we collate experience with pre-filled syringes from other clinical settings to inform on their practicality and suitability for IgRT. In addition to discussing drug characteristics such as stability, pharmacokinetics, and efficacy, we focus on treatment delivery, physician/patient experience, costs, and the importance of education for the use of pre-filled syringes. Expert opinion: Perceived benefits of pre-filled syringes include accurate dosing, sterility, and reduced treatment time, while offering patients greater choice, convenience, and ease-of-use. Our review of clinical experience with pre-filled syringes supports this consensus. Relatively few studies directly compare pre-filled syringes with conventional administration, and robust studies of cost-effectiveness and health-related quality of life are needed on a drug-by-drug basis. Growth in the availability of pre-filled syringes will continue, encouraged by the importance of patient choice and treatment convenience, toward the goal of individualized treatment regimens and improved quality of life.
... 6 Single-dose PFS formats of influenza vaccines are widely used and help to simplify administration, prevent dosing errors, and reduce vaccine waste. 7 However, they also have some disadvantagesnotably their cost per dose may be higher than alternative formats and they require substantial cold storage space and transport capacity. 7,8,9 In addition, because of limitations in their filling capacity, manufacturers may not be able to meet the vaccine needs of all countries through single-dose format production, which could lead to interruptions in global supply. ...
... 7 However, they also have some disadvantagesnotably their cost per dose may be higher than alternative formats and they require substantial cold storage space and transport capacity. 7,8,9 In addition, because of limitations in their filling capacity, manufacturers may not be able to meet the vaccine needs of all countries through single-dose format production, which could lead to interruptions in global supply. ...
... Thiomersal has been evaluated as a safe preservative for vaccines by the WHO Global Advisory Committee on Vaccine Safety 10 and by several other international health authorities. 11,12 While trivalent influenza vaccines are readily available in MDV formats, 7 QIVs are only beginning to be produced in this format. 13 Sanofi Pasteur has developed a 10-dose MDV format of QIV, which differs from QIV in the PFS format only by the addition of thiomersal during the final blending process. ...
Article
Full-text available
Annual vaccination is the most effective way to prevent seasonal influenza. Influenza vaccines in multi-dose vial (MDV) formats can facilitate timely vaccination of large populations by reducing per-dose costs and cold storage requirements compared to single-dose pre-filled syringe (PFS) formats. MDV vaccines require thiomersal or another preservative to prevent microbial contamination. We conducted a randomized, open-label trial in 302 healthy subjects aged 6 months to 17 years to evaluate the immunogenicity and safety of a quadrivalent influenza vaccine (QIV) in a thiomersal-containing MDV format compared to the licensed thiomersal-free PFS format. Subjects were randomly assigned in a 1:1 ratio to receive the MDV (n=153) or PFS (n=149) format. Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups. Seroconversion rates per strain were also comparable between the two groups. There were no differences in reactogenicity or safety between the two vaccine formats. These results showed that the MDV format of QIV was as safe and immunogenic as the PFS format in infants, children, and adolescents. These findings support the use of MDV QIV as a resource-saving alternative for seasonal influenza vaccination.
... Prefilled syringes (PFS) of therapeutic proteins, such as insulin, are a rapidly growing and more advantageous mode of drug delivery than their syringe and vial predecessors [1,2,3]. According to a report by Smithers Rapra, the global market for PFS is expected to grow from $3 billion in 2013 to $6.6 billion by 2020, which will translate to the production of 6.7 billion PFS units that year [4]. ...
... This is unsurprising; a study conducted in a private Indian market found that the mean vaccination time and handling errors associated with PFS was twice as fast and three times fewer than the syringe and vial format, respectively [5]. In fact, PFS are generally considered more convenient, accurate and cost-effective [2]. Hence, given the need for dosage accuracy, and the high commercial demand, it is important for PFS manufacturers to ensure good mechanical performance of their units. ...
Article
Full-text available
Protein drugs such as insulin are almost universally delivered via glass syringes lubricated with silicone oil. It is not uncommon for prefilled syringes (PFS) to become cloudy, which may affect bioavailability or total drug dose. To examine the role, if any, of the silicone oil lubricant in this process, a systematic evaluation of the degree of insulin denaturation and aggregation as a function of silicone oils of different molecular weights was undertaken. The former was measured using fluorescence changes of aqueous insulin/silicone dispersions, while the latter examined changes in turbidity as a function of mixing and silicone oil type; the results were confirmed at two different insulin concentrations and agitation speeds. Lower molecular weight silicones led to the most rapid denaturation and aggregation, and when examined in blends of silicones at a fixed viscosity of 1000 cSt, commonly used for syringe lubrication, more rapid denaturation/aggregation was noted in blends of silicones containing the largest fractions of low molecular weight materials. As a consequence, the molecular weight profile of silicone lubricants should be established prior to the preparation of prefilled syringes.
... Five summarized costs from all the perceived cost drivers and presented findings as cost per dose administered. In four of the studies, lower-capacity MDCs resulted in higher cost per administered dose for the different scenarios modeled in each study [1,6,9,11], taking into account the factors incorporated in the model and their effects on the modeled countries, including cold chain capacity, vaccine availability, wastage, and/or waste disposal. The fifth study modeled nine different scenarios, each modeling one antigen and DPC presentation against another presentation (both replacing higher dose per container vials with lower capacity dose per container vials and vice versa) and one scenario including a combination of changes for multiple antigens. ...
... Of the ten studies in the literature review, five mentioned the greater safety risk of adverse events following immunization (AEFI) associated with higher-capacity MDCs; of these one study provided a serious discussion on safety but this did not include metrics or further analysis [9]. This greater risk, which is due to risks of contamination between vaccinations, improper labeling of opened vials, and in some cases the presence of preservatives [3,4,13], is suggested but not well quantified in immunization programming. ...
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Full-text available
The widespread use of multidose vaccine containers in low and middle income countries’ immunization programs is assumed to have multiple benefits and efficiencies for health systems, yet the broader impacts on immunization coverage, costs, and safety are not well understood. To document what is known on this topic, how it has been studied, and confirm the gaps in evidence that allow us to assess the complex system interactions, the authors undertook a review of published literature that explored the relationship between doses per container and immunization systems. The relationships examined in this study are organized within a systems framework consisting of operational costs, timely coverage, safety, product costs/wastage, and policy/correct use, with the idea that a change in dose per container affects all of them, and the optimal solution will depend on what is prioritized and used to measure performance.
... That said, findings are consistent with several recent time and motion vaccine workflow studies revealing similar time savings with reduced vaccine reconstitution or preparation steps (~33 seconds). [18][19][20][21] In addition, other vaccine administration cost studies produced estimates ranging between $5 and $14/dose, [22][23][24][25] which help contextualize these results by showing the relative increase in cost of the additional workflow requirements of each vaccine over and above standard practice. Compared with results from these studies, the $1.64/dose allocated to time for BNT162b2 on extra workflow processes beyond standard requirements represents a 12% to 20% increase in time cost. ...
Article
Full-text available
In early 2020, the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak a global pandemic. In response, two novel messenger RNA (mRNA)-based vaccines: mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) were rapidly developed. A thorough understanding of the differences in workflow requirements between the two vaccines may lead to improved efficiencies and reduced economic burden, both of which are crucial for streamlining vaccine deployment and minimizing wastage. Vaccine administration workflow costs are borne by providers and reimbursed separately from dose acquisition in the United States. Currently, mRNA-1273 and BNT162b2 are the most administered COVID-19 vaccines in the United States. In this study, US-licensed and practicing pharmacists were interviewed to collect data on differences in terms of labor costs associated with the workflows for mRNA-1273 and BNT162b2. Results suggest the cost differential for mRNA-1273 compared to BNT162b2 is −$0.82 (or −$1.01 when assuming volume equivalency). If extrapolated to even just a proportion of the remaining unvaccinated US population, this can amount to significant workflow efficiencies and lower vaccine administration costs. Further, as key differences in the vaccine workflow steps between the two vaccines would be similar in other settings/regions, these findings are likely transferable to health-care systems worldwide.
... As a consequence, the time saved may be spent on streamlining the vaccination session and providing parents with a more detailed vaccination counselling [15]. In addition, it has been reported that the higher acquisition costs of RTU vaccines are counterbalanced by lower administrative costs and increased safety compared with single-dose and multi-dose vial vaccines [16,17]. In Italy, pediatric vaccinations are delivered by the public health sector, either in vaccination centers or in family pediatricians' medical offices. ...
Article
Introduction: In Italy, three hexavalent pediatric vaccines are available: two are ready-to-use (RTU) as pre-filled syringes, while the third must be reconstituted (need-for-reconstitution [NFR]). The formulation is related to the vaccination timing, safety of preparation and administration, and possible errors in immunization. We surveyed Italian healthcare professionals (HCPs) experienced with RTU and NFR vaccines in order to investigate their opinions on key aspects of the vaccines. Methods: In Q1 2018, a qualitative study, ethnographic observations and in-depth interviews were performed in public vaccination settings of three Italian Regions. Data on how the vaccination process was managed and perceptions about the value of the RTU formulation were collected. In Q2 2018, face-to-face interviews were carried out to explore the attitude and preferences of Italian HCPs from nine Regions, assessing advantages and disadvantages of the two formulations from a quantitative point of view. In Q3-Q4 data analysis was carried out, using both qualitative and quantitative methodologies. Results: The first phase demonstrated the following advantages of the RTU versus the NFR formulation: time-saving, lower probability of needle contamination and needle stick incidents, better handling, simpler procedure, easier disposal of waste. For the survey, 149 HCPs were interviewed; 80% and 40%, respectively, were very satisfied with the RTU and NFR vaccine. Conclusions: Our study demonstrated that HCPs prefer the RTU formulation, as it simplifies vaccinations, reduces preparation time and minimizes the risk of errors. This formulation also saves time that can be spent on more in-depth counseling.
... In 2000, Scheifele et al. found that prefilled syringes were associated with additional costs [11] . However, other studies have reported potential cost savings [12][13][14][15] . Two French studies evaluated the cost of administration of ephedrine by comparing ampoules/vials applications with prefilled syringes. ...
Article
Full-text available
Objective: The risk of errors in the medication administration process is high. Applications of prefilled syringes may improve patient safety but could be more costly. The objective of this study was to assess the additional costs of a ready-to-use syringe delivery programme in comparison with a conventional delivery programme at day surgery and endoscopy departments at a large university hospital. Methods: The cost analysis used the hospital perspective and developed an " activity-based costing " model to assess the costs of medicine-handling activities. The model was calibrated with six-month data from a ready-to-use syringe delivery programme. Detailed measures of time and resource use related to the preparation process were obtained by direct observations. Registry-based data on activity, consumption and discards were obtained before and after the implementation to supplement the observed data. Local unit costs were converted to 2013-€ to estimate the incremental costs. Results: The analysis showed that the ready-to-use programme was more costly than the conventional delivery programme. The annual incremental cost for the day surgery department was estimated at €70,469 (an increase of 105%) and at €20,905 (an increase of 228%) for the endoscopy department. The ready-to-use delivery program imposed an additional cost of €11.32 per day surgery operation and €2.41 per endoscopy procedure. Conclusion: This ready-to-use programme increased the cost of the medical handling process. This incremental cost is likely to provide improvements in the quality of the administrative process, patient safety and staff satisfaction.
Article
Background Hong Kong experiences year-round influenza activity with winter and summer peaks. The government’s Vaccination Subsidy Scheme (VSS) provides vaccine to high-risk groups prior to the larger winter peak. The VSS is predominantly administered through the private sector. This study aimed to cost the two theoretical routine influenza vaccination schedules using both northern and southern hemisphere vaccines, administered according to child’s age and women’s gestation, from a governmental perspective; and compare these costs to the costs of government’s seasonal VSS assuming equivalent coverage estimates to determine the budget impacts of these influenza vaccination programmes in Hong Kong. Methods We used the World Health Organization’s Flutool Plus to estimate the incremental annual costs for immunising young children aged 6 months to 2 years and pregnant women with influenza vaccine during 2021, assuming the latter group accesses the public system for some antenatal care. Inputs were based on literature review, publicly available data and expert opinions. Sensitivity analyses were done with various coverage rates and vaccine costs. Results The annual incremental cost (including vaccine price) to vaccinate young children with three doses of influenza vaccine during the first two years of life was estimated at USD 1,175,146 (per-dose-cost of USD 10.55) at 75% coverage while that to vaccinate pregnant women with one dose at 60% coverage was estimated at USD 398,555 (per-dose-cost of USD 13.39). Across a range of sensitivity analyses we predict that routine year-round schedules could be cost-saving to the government compared to the VSS. Implementing routine immunisation to both risk groups equates to USD 1,573,701, i.e., 0.012% of Hong Kong’s annual healthcare spending. Conclusion Proposed year-round universal schedules providing influenza immunisation according to the child’s age or the woman’s gestation are predicted to be cost-saving compared to the current seasonally administered subsidised vaccine programme.
Article
Full-text available
Developing a vaccine against the global pandemic SARS-CoV-2 is a critical area of active research. Modelling can be used to identify optimal vaccine dosing; maximising vaccine efficacy and safety and minimising cost. We calibrated statistical models to published dose-dependent seroconversion and adverse event data of a recombinant adenovirus type-5 (Ad5) SARS-CoV-2 vaccine given at doses 5.0 × 1010, 1.0 × 1011 and 1.5 × 1011 viral particles. We estimated the optimal dose for three objectives, finding: (A) the minimum dose that may induce herd immunity, (B) the dose that maximises immunogenicity and safety and (C) the dose that maximises immunogenicity and safety whilst minimising cost. Results suggest optimal dose [95% confidence interval] in viral particles per person was (A) 1.3 × 1011 [0.8–7.9 × 1011], (B) 1.5 × 1011 [0.3–5.0 × 1011] and (C) 1.1 × 1011 [0.2–1.5 × 1011]. Optimal dose exceeded 5.0 × 1010 viral particles only if the cost of delivery exceeded £0.65 or cost per 1011 viral particles was less than £6.23. Optimal dose may differ depending on the objectives of developers and policy-makers, but further research is required to improve the accuracy of optimal-dose estimates.
Article
Background: Benin, a country eligible for Gavi support, changed the presentation of the 13-valent pneumococcal vaccine (PCV13) from the single-dose vial (SDV) to the multi-dose vial (MDV). The present work aims to evaluate the process of making this decision as well as programmatic and logistic impacts. Methods: WHO protocol for post-introduction evaluation (PIE) was used. Programmatic impact was evaluated by comparing PCV13 coverage and dropout rates with a comparator vaccine administered simultaneously over similar 6-month periods prior to and after the transition. This impact was also appreciated from observation of multi-dose vial management practices during immunization sessions. Logistic impact was measured from the analysis of storage capacities, waste management and vaccine losses. Results: Decision to move to PCV13 MDV was taken at EPI level. Activities planned to support this switch were partially implemented. Impact on vaccination coverage and PCV13 dropout rates in relation with the transition to PCV13 MDV was not detected. The study found that 63% of the health staff surveyed knew and applied WHO's multidose vial policy (MDVP). Vaccines opened vials were found in 83% of health facilities visited. PCV13 MDV (37%) was one of the 3 main vaccines found with open vials in health facility refrigerators. Vaccination risky practices were observed during immunization sessions in 83% of health facilities. The main risky practice was the lack of indication of the date and hour of opening vials (56%). There was a reduction of the volume occupied by vaccines at central store by 47%. Net storage volume per fully immunized child (FIC) decreased from 69.5 to 41 m3. PCV13 MDV allows for 40% reduction in the amount of waste produced by vaccination. PCV13 open vial loss rate has increased from 3 to 7%. Conclusion: Benin's experience in transition to an MDV presentation of PCV13 reveals the need for better preparation and planning.
Article
We studied the clinical usefulness of prefilled syringe containing influenza vaccine preparations (PFS) for subject nurses and pharmacists. In this study, the result of a questionnaire survey concerning the convenience of PFS for operators and the time required to prepare for vaccination were evaluated using two kinds of vial preparations as controls. In terms of convenience for operators, for 25 items among the 27 questionnaire items relating to operation efficiency, prevention of medical malpractice, prevention of drug contamination, safety of operators, operability of syringe and storage/disposal, PFS was evaluated significantly higher in comparison to vial preparations (p < 0.0167). In addition, in case of PFS, maximum 31.7% of the time required to prepare for vaccination of vial preparations could be reduced. Thus, it was found that PFS was highly useful preparations at clinical sites. Therefore, further development of PFS as well as increased supply is awaited.
Article
As additional vaccines for adolescents come to market, physicians are confronted with multiple barriers to providing immunizations, including vaccine costs, concerns about safety, attitudes and/or knowledge, and obtaining adolescent consent. Immunization rates in adolescents could be improved by increasing providers' knowledge about recommended vaccines, providing information about vaccine safety to parents and patients, and taking care not to miss any vaccination opportunities.
Article
The goal was to describe variable costs to providers of delivering childhood immunizations. We documented variable costs (costs that vary with the amount of services rendered), including time spent by pediatric staff members and physicians on immunization-related activities, as well as supply costs and medical waste disposal costs. Ten private pediatric practices in the Denver, Colorado, metropolitan area participated in the study. Among the 7 practices that provided us with payment data, 8 health plans were mentioned by > or = 2 practices. There were 37 different agreements between the health plans and practices for vaccine administration payments. The total documented variable cost per injection (excluding vaccine cost) averaged $11.51, calculated from the following categories: nursing time, $1.71; billing services, $2.67; nonroutine services, $1.64; registry use, $0.96; physician time, $4.05; supplies, $0.36; medical waste disposal, $0.12. Nonroutine activities primarily included performing vaccine inventory and ordering, providing vaccination records to requesters, and answering parent telephone questions about vaccinations. With the use of a simulation model to compensate for the small number of participating practices, the calculated total variable cost per injection was $11.83. When 2 vaccines were administered, we compared the sum of the 2 payments with the sum of the 2 variable costs ($23.02). More than one third of the payment agreements (13 of 37 agreements) paid the practices less than the combined variable costs for 2 immunizations. This study shows that the variable costs of vaccine administration exceeded reimbursement from some insurers and health plans.
Article
Large immunization clinics are commonly held to deliver influenza vaccine to seniors and others. Vaccine is typically dispensed from multi-dose vials but pre-filled syringes are now available, offering time savings for vaccinators. To determine if the higher purchase price of such syringes is offset by savings in time and injection supplies, we did a controlled comparison of syringe and vial formats in two large, concurrent, community-based influenza vaccination clinics. Vaccine preparation and immunization times were carefully documented along with costs for vaccine purchase, storage and injection supplies. Servicing 1,000 clients required 27 nurse hours using syringes and 36 hours using vials but the savings for personnel ($234) and supplies ($1,190) using syringes were exceeded by higher vaccine cost ($2,090 premium) and extra storage costs ($260) for bulkier packaging. Depending upon product and packaging style, programs using vials are cheaper by $709-$926 per 100 doses delivered compared to using pre-filled syringes.