Cost-effectiveness of hospital vaccination programs in North Carolina

Vaccine 25 (2007) 1484–1496

Cost-effectiveness of hospital vaccination programs in North Carolina Amanda A. Honeycutt a,∗ , Margaret S. Coleman b , Wayne L. Anderson c , Kathleen E. Wirth d a b

RTI-UNC Center of Excellence in Health Promotion Economics, RTI International1 , 2951 Flowers Road South, Atlanta, GA, United States Centers for Disease Control and Prevention, National Immunization Program, Immunization Services Division, Atlanta, GA, United States c Aging, Disability, and Long-Term Care Program, RTI International, Research Triangle Park, NC, United States d Harvard School of Public Health, Boston, MA, United States Received 30 May 2006; received in revised form 11 October 2006; accepted 17 October 2006 Available online 10 November 2006

Abstract Although influenza and pneumonia are largely vaccine-preventable, vaccination coverage rates are well below Healthy People 2010 goals. The aim of this study was to examine the costs and cost-effectiveness of three provider-based vaccination interventions in the hospital setting: standing orders programs (SOPs), physician reminders (PRs), and pre-printed orders (PPOs). Data on program operating costs and the numbers of patients who received influenza or pneumococcal vaccinations were collected from nine North Carolina hospitals. Results demonstrated that the additional cost per patient vaccinated in 2004 was US $58 for SOPs, US $90 for PRs, and US $412 for PPOs. These findings suggest that SOPs are a cost-effective approach for increasing adult vaccination coverage rates in hospital settings. © 2006 Elsevier Ltd. All rights reserved. Keywords: Standing orders; Vaccination; Cost-effective

1. Introduction Combined, influenza and pneumonia are the fifth leading cause of death among people over age 65 [1–3]. However, vaccination coverage rates for influenza and pneumococcal disease, which contribute to many pneumonias, are well below Healthy People 2010 goals [4–6]. This study examined the cost-effectiveness of standing orders programs (SOPs), pre-printed orders (PPOs), and physician reminders (PRs) in multiple hospitals. SOPs authorize non-physician personnel to deliver vaccines without prescriptions or vaccine orders after patients are screened for high-risk conditions and contraindications. PPOs are unsigned vaccination orders that are placed in admission packages or patient charts and that require a physician signa∗ 1

Corresponding author. Tel.: +1 770 234 5014; fax: +1 770 234 5030. E-mail address: [email protected] (A.A. Honeycutt). RTI International is a trade name of Research Triangle Institute.

0264-410X/$ – see front matter © 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2006.10.029

ture for vaccination. PRs are notes placed in patient charts to remind physicians to determine patient eligibility and order the vaccination. Findings from the literature demonstrate that all three programs are effective at increasing vaccination coverage rates, but SOPs have been associated with higher coverage rates than either PPOs or PRs [7–22]. A unique contribution of the current study is that it compares the effectiveness and cost-effectiveness of all three-vaccination program types. The study also expands our understanding of existing intervention programs (as compared with pilot programs) and analyses data from multiple hospitals. Most studies in the literature have evaluated the effectiveness of pilot SOP, PPO, or PR programs, but pilot programs may not capture the complexities of implementing vaccination programs, such as the approvals required from many layers of hospital management and administration. The inclusion of several hospitals allowed for the analysis of program costs and cost-effectiveness in different settings (Table 1).

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Table 1 Characteristics of North Carolina hospital study sample (N = 9) Hospital ID

Program typea

Location Urban

A B C Dc E F G H J

SOP SOP SOP SOP, PPO PPO PPO PR PR PR

Totald (percentage) a b c d

×

11

Teaching hospital Rural × × × × × × × × 89

Sizeb Small

× ×

× ×

× × ×

22

Medium

22

×

44

Large

× × ×

33

Program types are standing orders program (SOP), pre-printed order (PPO), and physician reminder (PR). Small, ≤100 beds; medium, 101–300 beds; large, ≥301 beds. One hospital location with two distinct vaccination programs. Numbers may not sum to 100 due to rounding.

2. Methods 2.1. Overview Nine North Carolina hospitals with existing influenza and pneumococcal vaccination programs were studied. In 2004, the hospitals answered an e-mailed questionnaire about their vaccination program costs and outcomes. During follow-up site visits, personnel in charge of the vaccination programs were interviewed to verify and discuss their responses. Cost-effectiveness analysis (CEA) was conducted from the hospital perspective using self-reported estimates of vaccination program costs in 2004 dollars. Effectiveness was measured as the number and percentage of admitted patients vaccinated over a 6-month period, from October 2003 through March 2004. 2.2. Study sample In 2004, the North Carolina Hospital Association (NCHA) e-mailed all member hospital administrators asking for volunteers to participate in a study of vaccination programs. The volunteer study sample consisted of nine hospitals with a variety of characteristics (see Table 1), all of which reported using SOPs for vaccination. During hospital site visits, interviewers discovered that many of the hospitals required physician orders for vaccination, despite reporting that they used an SOP. Interviewers reclassified the 10 immunization programs as follows: 4 SOPs, 3 PPOs, and 3 PRs. One hospital used an SOP for influenza and a PPO for pneumococcal vaccination. These vaccination programs were applied to all admissions and were not limited to patients with pneumonia.

costs only for SOPs but was adjusted to include PPOs and PRs. Most hospital interviewees prepared written responses, which allowed discussion to focus on clarification of answers. Hospitals provided retrospective estimates of staff time and other resource requirements for five program activities: (1) screening, (2) identifying patients eligible for one or both vaccines based on interviews to determine previous vaccination status and contraindications, (3) ordering vaccine(s), (4) administering vaccine(s), and (5) recording vaccine administration. These values were used to estimate ongoing program costs. Because hospitals used the same form to screen simultaneously for influenza and pneumococcal vaccination, no attempt was made to estimate separate costs for each vaccine. Program outcomes were also collected during interviews and included the: (1) number of hospital admissions, (2) percentage of screened patients determined to be at high-risk (see Appendix A), (3) percentage of high-risk patients eligible for one or both vaccines, and (4) percentage of eligible patients for whom at least one vaccine was ordered. Six programs had already collected data on program performance, so estimates of (2), (3), and (4) for those programs were based on data. These hospitals collected data over a 6-month period from October 2003 through March 2004.2 The other four programs provided their best estimates for the same time period. All program cost and outcome data were collected in the first and second quarters of 2004. 2.4. Analysis 2.4.1. Program effectiveness The first program effectiveness measure was an estimate of the number of patients for whom at least one vaccine was ordered. Hospitals provided information about admissions

2.3. Data collection Prior to site visit interviews, the study team sent a questionnaire to hospitals that was originally developed to collect

2 One hospital is an exception in that it provided data for the 4-month period from October through January for influenza and for a 7-month period that included October through April for pneumococcal vaccine.

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Table 2 Hospital-reported proportions, by vaccination program type and by activity Program typea

SOP PPO PR

No. of hospitals

4 3 3

Mean proportions (range) P (high-risk given screened)

P (eligible given high-risk)

P (order given eligible)

0.57 (0.42–0.65) 0.52 (0.50–0.53) 0.50 (0.29–0.70)

0.37 (0.22–0.52) 0.53 (0.29–0.70) 0.56 (0.24–0.80)

0.48 (0.31–0.60) 0.15 (0.10–0.22) 0.39 (0.08–0.85)

P, proportion. a Program types are standing orders program (SOP), pre-printed order (PPO), and physician reminder (PR).

and the estimated proportion of patients screened with a vaccine order. All of the study hospitals used a single form to screen patients for both influenza and pneumococcal vaccination. Measures of vaccine eligibility from these hospitals focused on the need for at least one of the two vaccines, which made it infeasible to estimate eligibility for influenza vaccination separately from eligibility for pneumococcal vaccination. The study team was therefore unable to construct separate effectiveness measures for influenza and pneumococcal vaccinations. In addition, because data were combined across all age groups and other high-risk conditions, analyses at the subpopulation level were not possible. Table 2 presents means and ranges of these proportions by program type. These data and an iterative process (Fig. 1) were used to calculate the number of patients screened, at high-risk, eligible, and with at least one vaccine order. The result was an estimate of the number of patients for whom at least one required vaccine was ordered. All study hospitals reported screening rates of 98–100%, but because these estimates were considerably higher than screening rates reported in the literature, a rate of 90% was assumed for all study hospitals. Lacking hospital reports or observations, the researchers assumed that 100% of ordered vaccines were administered and recorded.

The second effectiveness measure was the percentage of admitted patients for whom at least one vaccine was ordered. This value was calculated by dividing the estimated number of patients with a vaccine order by the annual number of admissions reported by the hospital. 2.4.2. Program costs Per patient costs were estimated for each of the five program activities by multiplying per patient staff time required for the activity by each staff member’s hourly wages and benefits. Non-labor resources were also valued and included in per patient estimates. A standard approach for valuing community prevention program costs was used, following the recommendations of Haddix et al. [15]. Physician salaries were estimated using Bureau of Labor Statistics salary data for internists in North Carolina [16]. For one hospital that did not report personnel benefits, the mean benefits rate for the other hospitals was used. Aggregate annual costs for each vaccination program activity were calculated as the estimated number of patients affected by the activity multiplied by the per patient activity cost (Fig. 2). Aggregate costs were then summed across the five activities to estimate aggregate annual costs for the vaccination program.

Fig. 1. Method for estimating the number of patients vaccinated.

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Fig. 2. Method for estimating activity and total vaccination program cost.

2.4.3. Incremental cost-effectiveness analysis The average cost per patient vaccinated was calculated for each program by dividing aggregate annual program costs by the estimated number of patients vaccinated per year. To yield comparable measures of costs and effectiveness across hospitals, program costs and the number of patients vaccinated were divided by the number of patients admitted per year, resulting in estimates of the cost per admitted patient per year and the proportion of admitted patients who were vaccinated. The means of these values were calculated for SOPs, PPOs, and PRs to enable comparisons of program costs and effectiveness across immunization program types. The incremental cost-effectiveness (ICE) of each vaccination program type was then calculated in comparison with the alternative of no formal vaccination program. Data from control programs in the literature [10–12,17,18,20,21,23] were used to estimate the percentage of admitted patients vaccinated in the no vaccination program scenario. However, data on costs could not be identified; therefore, zero costs were conservatively assumed for the purposes of comparison with SOP, PPO, and PR costs, even though vaccination would clearly have positive costs. The ICE ratio (ICER) of each immunization program type as compared with no program was calculated as follows: ICERi, 0 = (Costi − Cost0 )/(P Vaccinei − P Vaccine0 ), for all i,

(1)

where i represents the vaccination program type (SOP, PPO, or PR), 0 denotes no formal program, Cost represents the mean cost per admitted patient, and P Vaccine represents

the percentage of admitted patients vaccinated. Because zero costs were assumed for the baseline of no vaccination program, ICERs were calculated by dividing program costs by the additional proportion of admitted patients vaccinated above what would be expected if no program were in place. 2.5. Sensitivity analysis One-way sensitivity analyses were performed by considering the impact on the cost-effectiveness analysis results of assigning the same high-risk and eligible patient mix to each hospital and by evaluating ICERs using the minimum and maximum cost for each program activity. Estimates from the literature on the mean effectiveness of SOPs, PPOs, and PRs were also used in sensitivity analyses to examine the extent to which findings are driven by estimated effectiveness rates in the nine study hospitals. 3. Results 3.1. Estimated effectiveness The number of admitted hospital patients who had at least one vaccine ordered for them ranged from 16 to over 1800 (Table 3). The percentage of admitted patients who were vaccinated ranged from 3 to 18% across the 10 vaccination programs. The mean percentage vaccinated was 8.9% for SOPs, 7.9% for PRs, and 3.2% for PPOs (see Table 3). A PR program had the highest estimated program effectiveness (18%), while the other two PRs had effectiveness rates

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Table 3 Estimated number and percentage of admitted patients vaccinated, by vaccination program type and by hospital Program typea

Hospital ID

SOP

A B C D

Number vaccinated

Mean PPO

D E F

Mean PR

G H J

Mean a

Percentage vaccinated (%)

986 382 102 1819

13.5 11.1 6.1 5.0

822

8.9

1107 256 224

3.0 3.7 2.8

529

3.2

635 16 126

17.8 3.1 2.8

259

7.9

Program types are standing orders program (SOP), pre-printed order (PPO), and physician reminder (PR).

Table 4 Estimated per patient activity and total annual costs (US $) by vaccination program type Activity

PPO

PR

Mean (across all program types)

Per-patient activity costs by program type mean (range)a Screen 0.86 (0.29–1.83) Determine eligibility 4.59 (1.75–10.09) Order vaccine 4.93 (3.91–6.54) Administer 3.95 (0.38–7.84) Record keeping 2.42 (0.48–3.96)

1.64 (0.29–2.38) 7.34 (2.85–15.60) 12.03 (7.56–14.60) 6.06 (3.58–7.84) 4.06 (2.25–7.55)

1.92 (1.41–2.30) 7.06 (2.82–13.31) 11.03 (6.60–14.54) 3.95 (1.13–6.13) 2.24 (1.32–3.11)

1.40 6.20 8.90 4.60 2.90

Total annual vaccination costsb All activities

64,450 (27,510–84,778)

17,370 (1,840–27,926)

38,530

a b

SOP

34,960 (6,032–87,534)

Program types are standing orders program (SOP) (n = 4), pre-printed order (PPO) (n = 3), and physician reminder (PR) (n = 3). Calculated for each hospital program using per-patient activity costs and numbers of patients affected by each activity, as shown in Fig. 1.

similar to those of the PPOs in the study (3%).3 The SOPs had effectiveness rates of 5–14%. 3.2. Estimated costs Mean per patient costs by program activity were US $1.40 to screen, US $6.20 to determine eligibility, $8.90 to order the vaccine from the pharmacy, US $4.60 to administer the vaccine, and US $2.90 to record vaccine administration (Table 4). Total program operations costs varied widely, from US $1800 to 87,500 per year (Table 4). Mean program operations costs per patient were approximately US $4 for SOPs (US $2.40–7.20), US $5.60 for PPOs (US $2.30–10), and US $5.50 for PRs (US $3.60–7.80) (Table 5).

3

The 18% vaccination rate may be due to the fact that the hospital was small, one person championed and implemented the PR program (by writing notes in all charts for patients found to be eligible for vaccination), and physicians were reported to believe in the importance of inpatient immunization.

3.3. Cost-effectiveness The cost per patient vaccinated ranged from US $22 to 65 for SOPs. For PPOs, the estimated cost per patient vaccinated was US $77–362, and for PRs, the analogous cost was US $44–179 (see Table 5). The ICER for SOPs as compared with no vaccination program was US $58. The ICER for PRs was only slightly higher, at almost US $90. The ICER for PPOs was higher—US $412 per additional patient vaccinated (see Table 5). Mean SOP costs were lower and the percentage of patients vaccinated was higher than for the PPO and PR vaccination programs (see Table 5), suggesting that SOPs are more cost-effective than either PPOs or PRs. 3.4. Sensitivity analyses The ICE of SOPs, PPOs, and PRs, as compared with no formal vaccination program, varied little when the same patient mix was assumed. In this scenario, the estimated cost per admitted patient vaccinated was somewhat lower for SOPs (US $46) and PPOs (US $379), but did not change for

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Table 5 Estimated cost-effectiveness Hospital ID

Cost per admitted patient per year (US $)

Cost per patient vaccinated (US $)

Program typesa SOP

A B C D D E F G H J

3.00 7.20 3.80 2.40 2.30 4.50 10.00 7.80 3.60 5.00

21.90 64.70 63.20 48.10 76.60 121.60 361.70 44.00 115.50 179.40

Mean cost per admitted patient per year (A) (US $)b Net proportion of admitted patients vaccinated (B)c Incremental cost-effectiveness ratio (=A/B) (US $) a b c

× × × ×

4.10 0.070 57.60

PPO

× × ×

5.60 0.014 411.80

PR

× × × 5.50 0.060 89.70

Program types are standing orders program (SOP), pre-printed order (PPO), and physician reminder (PR). Calculated as total annual program costs/estimated number of patients admitted annually. Calculated as mean proportion of admitted patients vaccinated less the mean of 0.018 for control programs in literature [10–12,16,17,19,20,22].

PRs (US $92). Not surprisingly, when the minimum values for activity costs were used for all programs, estimated ICERs were considerably lower across all three programs. Compared with no formal program, the estimated ICER for SOPs was approximately US $22 per additional patient vaccinated. The ICER for PRs was US $24 and for PPOs was US $90. Similarly, when the maximum values for activity costs were used, ICERs were substantially higher for all three programs. The cost per additional patient vaccinated was approximately US $180 for SOPs, US $190 for PRs, and US $761 for PPOs. Finally, when effectiveness rates from the literature were used instead of those from study hospitals, incremental CERs were lower than baseline values for all three programs. The values were also closer in magnitude across the three program types. The mean cost per additional admitted patient vaccinated was US $12 for SOPs, US $42 for PPOs, and US $46 for PRs.

4. Discussion and conclusions This study analysed the cost-effectiveness of three different immunization programs (SOPs, PPOs, and PRs) across multiple hospitals. Findings showed that SOP programs had the lowest operations costs of the three (US $4.00 per patient admitted) and the highest net effectiveness (7.1%). Consequently, the estimated cost per additional patient vaccinated in a SOP was US $57.60, or as high as US $180 in sensitivity analyses, which may be acceptable to payers, especially given the high estimated cost per case of influenza and pneumonia among older adults and those with chronic illnesses [24–25]. An advantage of the multiple hospital approach is that it allows for the evaluation of the three different program types across hospitals with different characteristics. Yet, analysing

data from nine distinct hospitals presented challenges, such as how to control for differences in the patient populations, number of beds, primary mission (e.g., teaching or community health), and definitions of high-risk patients. The approach used in this study was to divide hospital-level cost and vaccination outcomes data by the number of patients admitted, creating an implicit weight. A number of other weighting schemes were considered to make the hospitals comparable, but weights used in the literature vary, and no general agreement exists among health economists about which is the best weighting scheme [14]. Other possible weights include those based on “geographic area, specialized services, primary care services, outpatient services, patient admittance levels, and in- and outpatient flow” [14]. Another challenge of working with multiple hospitals is the difference in high-risk and eligibility criteria across hospitals (Appendix). Hospitals that participated in the study developed their own definitions of high-risk and eligibility criteria; these criteria may not reflect current recommendations for influenza or pneumococcal vaccination. Some of the study hospitals included contraindications that differ from current recommendations for influenza and pneumococcal vaccination to satisfy the hospital board or other stakeholders (e.g., some hospitals treated residents of long-term care facilities as contraindicated). An unexpected finding from this study was the considerable variation in the types of vaccination programs in study hospitals. Although all hospitals in the sample originally reported using SOPs, interviews revealed that a physician’s written order was required for 6 of the 10 vaccination programs. These non-SOPs were best characterized as PPO or PR programs. Even among the hospitals that used SOPs, differences were reported in SOP leadership and staffing. For example, some hospitals relied on pharmacy staff to screen and identify vaccine eligibility, whereas others relied

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on infection control or nursing staff. Some hospitals hired additional staff members to perform program activities, while others used existing staff members; therefore, costs differed from hospital to hospital, even for the same program type. Another interesting finding was that SOPs had higher rates of ordering vaccines than PPOs and all but one of the PRs (see Table 2), suggesting that SOPs were more effective than PPOs or PRs at ordering vaccines for eligible patients. However, the findings also suggest that SOPs may have lower eligibility rates than PPOs and PRs (see Table 2). The difference in mean eligibility rates is not statistically significant across programs, but the comparatively lower mean eligibility rate for SOPs versus that for PPOs and PRs bears further examination. Although it is possible that the SOP hospitals in our study tended to have patients that were more likely to have already received influenza and pneumococcal vaccines, another possible explanation is that non-physician personnel were reluctant to identify sickly patients as eligible because of concerns about possible adverse events. Yet another possible explanation is that patients were more likely to refuse the vaccine if it was not recommended by a physician. Further study is needed to answer the question of whether fully implemented SOPs are less effective at identifying eligible patients than alternative programs that require physician involvement. This study is limited by the inclusion of self-selected hospitals and vaccination programs (versus random assignment), which could bias study results in favor of SOPs, especially if hospitals with greater physician or staff commitment to vaccination are more likely to implement SOPs. However, because all of the study hospitals initially reported using an SOP, any introduced bias based on staff commitment is expected to be small. Another limitation is that estimates may understate vaccination program costs if most patients were identified as eligible for both influenza and pneumococcal vaccines. Because all study hospitals used a single screening form for both vaccines, no attempt was made to estimate separate program costs. It is unclear whether interviewees provided time estimates that account for the need to order and administer both vaccines to some patients. However, this limitation is expected to affect all program types equally, resulting in possible underestimates of costs of similar magnitude for all three-program types. Another limitation is that study data were self-reported and not compiled from medical records. However, selfreports do not appear to be biased toward demonstrating better outcomes. For all three-vaccination programs, effectiveness rates from the study sample are lower than similarly defined rates in the literature.4 The mean effectiveness rate 4 Effectiveness from the literature was estimated as the number of patients vaccinated divided by the number of patients admitted. In two studies [14,17], the number admitted was actually the number of patients admitted up until a pre-selected number of eligible patients were identified. Where

for five published SOP hospital studies was 0.346 [9–13], compared with a mean effectiveness rate of 0.089 from the North Carolina study sample (see Table 3). In four published studies on hospital PPOs, average effectiveness was 0.148 [17–20] versus 0.032 in this study (see Table 3). The estimated effectiveness rate for PRs from five published studies in the literature was 0.136 [9,12–13,21,23] versus 0.079 in this study. Because the literature provides little information about the cost of hospital vaccination programs and virtually no information about fully implemented programs, comparisons of study costs with costs in the literature were not possible. This study’s focus on existing programs in multiple hospitals instead of on single-hospital pilot programs may explain why effectiveness rates were lower than those in the literature. Compared with pilot programs, fully implemented immunization programs may have a decline in staff commitment to immunization efforts over time, fewer staff members explicitly devoted to immunization efforts, and less awareness of staff impact on vaccination rates. A final limitation is that all study hospitals were in North Carolina, which may limit the applicability of results to other states because of different state and local practices and laws governing SOPs. Despite limitations, this study yields important insights. First, SOPs are cost-effective in a variety of inpatient settings. Second, many hospitals mistakenly believe that SOPs are any type of hospital program to administer influenza and pneumococcal vaccines. Third, implemented hospital vaccination programs are far more complex than can be understood by studying pilot programs. Fully implemented programs must deal with staff turnover and the frequent need to train new staff. In addition, changes in Medicare reimbursement rates and accreditation quality measures may shift hospital priorities and affect staff adherence to hospital-wide policies, such as vaccination interventions. Understanding the complexities of these policies as implemented in real-life settings may help public health policy makers promote community-based vaccination programs and ultimately improve vaccination rates among those who stand to benefit the most.

Acknowledgments This research was supported by the Centers for Disease Control and Prevention and the Association of Teachers of Preventive Medicine under cooperative agreement number TS-1230. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the funding agency. The authors thank the North Carolina Hospital Association staff and participating member hospitals for assistance.

separate values were given for influenza and pneumococcal vaccination, the simple average of the maximum vaccinated with each vaccine was calculated.

Appendix A. Definitions of high-risk for influenza or pneumonia, by hospital

Hospital ID

A (SOP)

Pneumococcal

Influenza

High-risk criteria

Eligible criteria

High-risk criteria

Eligible criteria

• Age 65 and older

• Contraindications include the following - Resident of long-term care facility - Surgery during current admission - Prior vaccination <5 years ago

• Age 65 and older

• Contraindications include the following - Resident of long-term care facility - Surgery during current admission - Prior vaccination in the current flu season - Allergic to eggs or thimerosal

• Age 19–64 and any of the following - Chronic heart or lung disease - Diabetes mellitus

- Compromised immunity, such as Hodgkin’s disease; leukemia or lymphoma; multiple myeloma; HIV infection or AIDS; organ or bone marrow transplant; treatment with long-term steroids, cancer drugs, or radiation therapy - Kidney failure or nephritic syndrome - Leaks of cerebrospinal fluid

- Chronic heart or lung disease - Kidney disease

- High-risk illness (physician to assess)

- Diabetes mellitus

- Severely compromised cardiovascular and/or pulmonary function, febrile respiratory illness, or other active infection - Hypersensitivity to vaccine components (e.g., thimerosal)

- Anemia or other blood disorders

- Physician order not to give

- Compromised immunity, such as HIV/AIDS and other diseases that affect the immune system; organ or bone marrow transplant; treatment with long-term steroids, cancer drugs, or radiation therapy - Congenital immunodefiency disorders

- Patient refusal - Patient uncertain - Patient unable to give reliable history - Pregnant or nursing mother

• Age 65 and older • Age 19–64 and any of the following - Chronic heart or lung disease

- Diabetes mellitus

- Physician order not to give

• Contraindications include the following - Prior vaccination < 5 years ago

• Age 50 and older

- Prior vaccination before age 65 and high-risk illness (physician to assess) - Hypersensitivity to vaccine components (e.g., thimerosal) - Physician order not to give

• Age 19–49 and any of the following

• Pregnant (second or third trimester)

- Chronic heart or lung disease - Kidney disease

• Contraindications include the following - Prior vaccination in the current flu season - Allergic to eggs or thimerosal

- Previous severe reaction to vaccine - History of Guillain-Barre syndrome 1491

- Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy)

- History of Guillain-Barre syndrome

- Patient refusal - Patient uncertain - Patient unable to give reliable history - Pregnant (physician approval needed) - Other

- Other B (SOP)

- Previous severe reaction to vaccine

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- Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) - Alcoholism

• Age 19–64 and any of the following

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Appendix A. (Continued ) Hospital ID

Pneumococcal High-risk criteria - Alcoholism - Compromised immunity, such as Hodgkin’s disease; leukemia or lymphoma; multiple myeloma; HIV infection or AIDS; organ or bone marrow transplant; treatment with long-term steroids, cancer, drugs or radiation therapy - Kidney failure or nephritic syndrome

Influenza Eligible criteria - Patient refusal - Other

• Age 19–64 and any of the following - Chronic heart or lung disease - Diabetes mellitus - Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) - Alcoholism - Compromised immunity, such as Hodgkin’s disease; leukemia or lymphoma; multiple myeloma; HIV infection or AIDS; organ or bone marrow transplant; treatment with long-term steroids, cancer drugs, or radiation therapy - Kidney failure or nephritic syndrome - Leaks of cerebrospinal fluid

• Contraindications include the following - Prior vaccination <5 years ago - Hypersensitivity to vaccine components (e.g., thimerosal) - Physician order not to give - Patient refusal

- Patient unable to give reliable history

• Age 50 and older • Age 19–49 and any of the following - Chronic heart or lung disease - Kidney disease - Diabetes mellitus

Eligible criteria - Physician order not to give - Patient refusal

- Other

• Contraindications include the following - Prior vaccination in the current flu season - Allergic to eggs or thimerosal - Previous severe reaction to influenza vaccine - History of Guillain-Barre Syndrome

- Anemia and other blood disorders

- Physician order not to give

- HIV infection or AIDS

- Patient refusal

- Organ or bone marrow transplant - Treatment with long-term steroids, cancer drugs, radiation therapy - Congenital immunodefiency disorders

- Patient unable to give reliable history

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• Age 65 and older

- Diabetes mellitus - Anemia or other blood disorders

- Compromised immunity, such as HIV/AIDS and other diseases that affect the immune system; organ or bone marrow transplant; treatment with long-term steroids, cancer drugs, or radiation therapy - Congenital immunodefiency disorders - Nursing home resident

- Leaks of cerebrospinal fluid

C (SOP)

High-risk criteria

D (SOP)

• N/A

• N/A

• Age 50 and older • Pregnancy after the first trimester • Age 50–64 and any of the following - Chronic heart or lung disease - Diabetes mellitus - Anemia and other blood disorders

- Congenital immunodefiency disorders

- Patient currently on heparin, enoxaparin, warfarin, or the antiplatelet agent eptifibatide or abciximab - Physician order not to immunize - Patient uncertain or refusal - Pregnancy in the first trimester

D (PPO)

Age 65 and older Age 19–64 and any of the following - CHF - COPD - Emphysema (not asthma)

- Cardiomyopathy - Liver disease - Renal failure - Sickle cell - Prior spleenectomy - Organ transplant - Long-term use of steroids - Diabetes mellitus - Compromised immunity, such as leukemia, lymphoma, multiple myeloma, HIV or AIDS, immunosuppressive medications

Contraindications include the following - Prior vaccination <5 years - Previous allergy to vaccine - Allergic to thimerosal or phenol - Undergoing/planned chemotherapy or radiation therapy within 2 weeks - History of idiopathic thrombocytopenic purpura - Patient refusal

N/A

N/A

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- Compromised immunity (e.g., HIV or AIDS; organ or bone marrow transplant; treatment with long-term steroids, cancer drugs, or radiation therapy) - Kidney disease

• Contraindications include the following - Prior vaccination in same season - Resident of long-term care facility - Acute febrile illness (temp ≥100.4 ◦ F) - Allergy to eggs or thimerosal - Previous severe reaction to vaccine - History of Guillain-Barre syndrome (physician to assess)

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Appendix A. (Continued ) Hospital ID

Pneumococcal High-risk criteria

Eligible criteria

High-risk criteria

Eligible criteria

E (PPO)

• Age 65 and older

• Contraindications include the following - Prior vaccination after age 65 or before age 65 but less than 5 years earlier - Hypersensitivity to vaccine components (e.g., thimerosal) - Physician order not to immunize

• Age 50 and older

• Contraindications include the following - Prior vaccination in the current flu season

• Age 19–64 and any of the following

- Chronic heart or lung disease - Diabetes mellitus

- Compromised immunity, such as Hodgkin’s disease; leukemia or lymphoma; multiple myeloma; HIV or AIDS; organ or bone marrow transplant; long-term steroid therapy, cancer drugs, or radiation therapy - Kidney failure or nephritic syndrome

F (PPO)

• Age 65 and older • Age 19–64 and any of the following - Immunocompromised - Chronic heart and/or lung disease - Renal failure - Diabetes

G (PR)

• Age 65 and older • Age 19–64 and a chronic condition (specific conditions were not noted and do not appear on the physician reminder form)

- Patient refusal

- Patient unable to give history (physician to assess) - Other (e.g., pregnancy, category C)

• If high-risk and no contraindications, PPO placed in chart for physician • Contraindications include the following - Prior vaccination <5 years ago - Patient refusal

• Contraindications include the following - Prior vaccination <5 years ago

- Current illness

• Age 19–64 and any of the following

- Chronic heart or lung disease - Kidney disease - Diabetes mellitus

- Anemia and other blood disorders - Compromised immunity, such as HIV or AIDS; organ or bone marrow transplant; long-term steroid therapy, cancer drugs, or radiation therapy)

- Allergic to eggs or thimerosal - Previous severe reaction to vaccine - History of Guillain-Barre Syndrome (physician to assess) - Physician order not to give - Patient refusal

- Congenital immunodefiency disorders

- Patient uncertain or unable to give reliable history (physician to access) - Other (e.g., pregnancy, category C)

• Age 50 and older

• If high-risk and no contraindications, PPO placed in chart for physician • Contraindications include the following - Prior vaccination in the current flu season - Patient refusal

• Age 19–49 and any of the following - Immunocompromised - Chronic heart and/or lung disease - Renal failure - Diabetes • Age 50 and older • Age 19–49 and a chronic condition (specific conditions were not noted and do not appear on the physician reminder form)

• Contraindications include the following - Prior vaccination in the current flu season

- Current illness

A.A. Honeycutt et al. / Vaccine 25 (2007) 1484–1496

- Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) - Alcohol abuse

Influenza

H (PR)

• Age 65 and older • Age 2–64 and any of the following - Chronic heart, lung, or liver disease - Diabetes - Alcoholism

• Contraindications include the following - Prior vaccination <5 years ago - Allergy to thimerosal - Hypersensitivity to vaccine in past - Current febrile illness

- Functional or anatomic asplenia

• Age 19–64 and a chronic condition (specific conditions were not noted and do not appear on the physician reminder form) • Residents of long-term care facilities

• Contraindications include the following - Prior vaccination

- Current illness - Hypersensitivity to vaccine components (thimerosal) - Other

• Age 50 and older • Age 19–49 and a chronic condition

• Residents of long-term care facilities

• Contraindications include the following - Prior vaccination in the current flu season

A.A. Honeycutt et al. / Vaccine 25 (2007) 1484–1496

• Age 65 and older

• Age 19–49 and any of the following - Chronic heart, lung, or kidney disease - Diabetes and other metabolic diseases - Anemia

• Contraindications include the following - Prior vaccination - History of serious allergic reaction to eggs - History of Guillain-Barre Syndrome - Any acute febrile illness (not minor illness with or without fever)

- Compromised immunity, such as Hodgkin’s disease, leukemia, lymphoma, multiple myeloma, HIV or AIDS, bone marrow or organ transplant, cancer drugs or radiation therapy - Congenital immunodefiency disorders

- Living in special environments or social settings (e.g., residents of long-term care facilities) - Compromised immunity, such as Hodgkin’s disease, leukemia, lymphoma, multiple myeloma, HIV or AIDS, bone marrow or organ transplant, cancer drugs or radiation therapy - Leaks of cerebrospinal fluid J (PR)

• Age 50 and older

- Current illness - Allergic to eggs or thimerosal - Previous severe reaction to influenza vaccine - Other

1495

1496

A.A. Honeycutt et al. / Vaccine 25 (2007) 1484–1496

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