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Vaccinating health care workers against smallpox in an isolated primary care facility

      Just as civilian emergency response teams and health care workers in the United States are being immunized against smallpox, primary care facilities in rural or isolated areas are being confronted with the need to develop terrorism response plans, including smallpox vaccination programs (

      Straziuso J. Rural counties emergency plan a potential nationwide model. Standard Speaker. June 20, 2003:17

      ). Many are reluctant to administer or receive the vaccine because of concerns about potential side effects, lower productivity, and providing compensation for medical expenses or lost wages to workers with persisting adverse reactions to the vaccine (
      • Stephenson J.
      Smallpox vaccine program launched amid concerns raised by expert panel, union.
      ,
      • Sepkowitz K.A.
      How contagious is vaccinia?.
      ,

      Cookson C. Nothing to fear but fear itself and some side-effects. Financial Times. February 1-2, 2003:22

      ,

      Wlazelek A. Health workers preparing for bio-terrorism. The Morning Call. January 19, 2003;B1:6

      ,

      3 of 100,000 react badly to vaccine. The Washington Post. February 14, 2003:A13

      ,

      Morello C. Experts split on need for terror protection. The Washington Post. February 18, 2003:B1

      ,

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). In April 2003, only a fraction of health care workers and first responders who were scheduled to receive the vaccine did receive it (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ,

      Ira Flatow. Interview with Brian Strom, chairman of the Committee on Smallpox Vaccination Program Implementation for the Institute of Medicine [transcript]. “Talk of the Nation/Science Friday.” National Public Radio. April 4, 2003. Available at: http://www.npr.org

      ). By July 2003, national security experts feared that the smallpox immunization program was all but dead (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). Some states such as Arizona and Nevada have immunized fewer than 50 people (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). Washington state has immunized only 543 of their initial goal of 7000 medical personnel (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ).
      Additionally, outcome studies of smallpox vaccination programs from tertiary care centers may not be entirely applicable to persons living in isolated or rural areas or to limited-capacity primary care settings. To aid planners and executives in such facilities, we describe our experience implementing a smallpox vaccination program and its effect on routine operations in an isolated United States military hospital and its nine satellite clinics in central Germany.

      Methods

      The Department of Defense smallpox response plans and procedures (http://www.vaccine.army.mil) were customized by the hospital's chief executive officer and bioterrorism response committee. The program included an extensive and systematic educational component. Every health care worker (n = 834), whether slated to receive the vaccine or not, was required to attend a 3.5-hour educational presentation on smallpox offered during the time regularly scheduled for education and training. However, because the time normally allotted (2 hours per month) was insufficient, an additional 1.5 hours had to be taken from standard operations. Various staff members were then appointed to special roles and required to complete additional hours of online training (http://www.smallpox.army.mil/digiscript.asp): 5.5 hours for supervisors and “vaccinators,” 7.5 hours for clinical consultants, and 9.5 hours for medical directors. This additional requirement was completed on personal time, outside of usual clinical responsibilities, with no compensation other than educational credit.
      The medical director held a 30-minute town hall meeting with family members of the vaccine candidates the evening before the scheduled immunization. On the day of vaccination, candidates first attended a compulsory briefing that emphasized wound care and transmission precautions. This session was held during clinic hours and lasted about 30 minutes depending on the number of questions. Immediately afterwards, the medical director or one of the clinical consultants screened records and interviewed candidates for contraindications to the vaccination. These included pregnancy, immunodeficiency disease, cancer, eczema, atopic dermatitis, or a household contact with any of the above conditions. Breastfeeding; allergy to latex; use of streptomycin, tetracycline, polymyxin B, or neomycin; or therapy with systemic corticosteroids, alkylating agents, antimetabolites, and radiation therapy were also considered contraindications. Vaccines were administered by registered nurses or medical technologists who had completed the 5.5-hour “vaccinator” requirement of the online smallpox education module.
      Vaccine recipients were given bandaging materials, including occlusive dressings, and instructed to return to the vaccination center in 6 to 8 days to determine if reimmunization was necessary. During business hours, questions were answered or adverse reactions were evaluated by a clinical consultant or the medical director in a separate building that was not routinely used for patient care. Because of infection control issues in our emergency department, and because more than 60% of the emergency department staff were pregnant or potentially pregnant women, the on-call primary care physicians, and not the emergency department physicians, evaluated adverse reactions that were reported after hours at a prearranged area outside the emergency department. Vaccinia immune globulin and cidofovir were stored 78 miles (130 km) away at our referral facility.

      Results

      One third of the entire staff (278 health care workers) were considered essential for a functional smallpox response team and were thus initially scheduled to receive the vaccine. Ninety-six percent (n = 267) completed the screening, of whom 68% (n = 182) received the vaccine (Table 1). Dividing the sum of the total time spent on administration of the program (112.3 hours) and the total time lost because of adverse reactions (65.2 hours) by the number of persons screened (n = 267) resulted in an average of 40 minutes of provider time spent per person (Table 2). The time spent on educating potential recipients was not used in this calculation because the amount of time required for education is the same regardless of the number of candidates screened or vaccinated. Adverse reactions that affected productivity consisted of debilitating malaise and fatigue, and a moderate skin reaction that was thought initially to be early progressive vaccinia, but that was actually a skin reaction to dressing adhesives.
      Table 1Characteristics of the 267 Candidates Screened for Smallpox Vaccination
      CharacteristicNumber (%) or Mean (Range)
      Age (years)34 (18–58)
      Vaccinated
      Including 129 men.
      182 (68)
      Active duty military256 (96)
      Permanent exemptions31 (12)
      Temporary exemptions61 (23)
      Temporary exemptions vaccinated7 (3)
      First-time recipients19 (7)
      “Non-take”/lack of skin reaction indicating vaccine activity5 (2)
      With duty-limiting adverse reactions2 (1)
      First-time recipients with duty-limiting adverse reactions1 (5)
      Revaccinated personnel with duty-limiting adverse reactions1 (0.6)
      * Including 129 men.
      Table 2Time Spent on the Vaccination Program
      Education
      1.5 hours × 834 staff members = 1251 hours
      9.5 hours × 4 medical directors = 38 hours
      7.5 hours × 8 clinical consultants = 60 hours
      5.5 hours × 24 vaccinators = 132 hours
      Town hall meetings: 2 @ 30 minutes each × 1 medical director = 1 hour
      Prevaccine education programs: 2 @ 30 minutes each × 1 medical director = 1 hour
      Total = 1483 hours
      Administration
      Record screening and candidate interview: 267 @ 15 minutes each = 66.8 hours
      Vaccine and distribution of aftercare supplies/instruction: 182 @ 10 minutes each = 30.3 hours
      Site checks: 182 @ 5 minutes each = 15.2 hours
      Total = 112.3 hours
      Adverse reactions
      Evaluation of adverse reaction during business hours: 10 @ 25 minutes each = 4.2 hours
      Evaluation of adverse reaction after hours: 6 @ 50 minutes each = 5 hours
      Work time lost due to adverse reactions = 56 hours
      Total = 65.2 hours
      Total time required for implementation = 1660.7 hours
      Total cost of supplies (excluding vaccine) = $455.00 ($2.50 per recipient)

      Discussion

      Some health care workers in the United States are refusing to receive the smallpox vaccine (
      • Sepkowitz K.A.
      How contagious is vaccinia?.
      ) or are hesitant about vaccinating their staff because of concerns about side effects (

      Straziuso J. Rural counties emergency plan a potential nationwide model. Standard Speaker. June 20, 2003:17

      ,
      • Stephenson J.
      Smallpox vaccine program launched amid concerns raised by expert panel, union.
      ,
      • Sepkowitz K.A.
      How contagious is vaccinia?.
      ,

      Cookson C. Nothing to fear but fear itself and some side-effects. Financial Times. February 1-2, 2003:22

      ,

      Wlazelek A. Health workers preparing for bio-terrorism. The Morning Call. January 19, 2003;B1:6

      ,

      3 of 100,000 react badly to vaccine. The Washington Post. February 14, 2003:A13

      ,

      Morello C. Experts split on need for terror protection. The Washington Post. February 18, 2003:B1

      ,

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). Experts contend that the anxiety about the dangerous adverse effects of the vaccine should be quelled by the success of the military in immunizing nearly half a million personnel with few serious complications (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). The Centers for Disease Control and Prevention estimated than it would take 1.25 million immunized health care workers to run enough emergency clinics to immunize the U.S. population within 10 days in the event of a bioterrorist attack (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ), although experts at Yale University believe that the country does not have that capability at present (

      Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      ). Outcomes at our facility suggest that even small or isolated facilities with limited resources can vaccinate their staff with minimal disruption of routine operations or productivity.
      We found prevaccination education for vaccine recipients and their family members, along with a preimplementation training program for providers doing the screening, to be useful. The low number of adverse reactions we observed was perhaps partly due to a robust prevaccination educational program and a low threshold for medical exemptions. Screening potential vaccine recipients was the most time-consuming part of the vaccination program. Having a dermatologist screen candidates expedited processing by minimizing the need for referrals to determine possible exemption in patients with a questionable history of eczema or atopic dermatitis.
      Many of the on-call physicians opposed the policy of having themselves, and not the emergency department staff, evaluate potential adverse reactions, believing that the precautions would needlessly result in extra call burden. Ultimately, the extra call burden was negligible.
      Three young children of a vaccinated health care worker were isolated and excluded from their day care center for 5 days because of skin lesions suggestive of secondary vaccinia. Polymerase chain reaction testing for herpes and vaccinia virus was negative. This health care worker did not miss any time from work, and the worker's insurance paid for the diagnostic tests.
      The majority of workers vaccinated were military personnel who could be ordered to undergo vaccination. Such a directive may be difficult to enforce in civilian populations. Furthermore, as was demonstrated by the substantial resistance to vaccination that the military encountered when implementing the anthrax vaccination program, personnel may refuse vaccination despite the possibility of severe disciplinary action or loss of career. Indeed, we learned that it is as important to address perceptions as it is to deliver scientific fact. The perceptions of potential vaccine recipients, whether accurate or not, markedly influenced their willingness to be vaccinated. We credit the systemic and aggressive preliminary educational campaign for the compliance in our smallpox vaccination program.
      Since the original submission of this report, approximately 2200 additional non–health care workers have been vaccinated in our program. There were no cases of secondary transmission or serious reactions except for one case of perimyocarditis.

      References

      1. Straziuso J. Rural counties emergency plan a potential nationwide model. Standard Speaker. June 20, 2003:17

        • Stephenson J.
        Smallpox vaccine program launched amid concerns raised by expert panel, union.
        JAMA. 2003; 289: 685-686
        • Sepkowitz K.A.
        How contagious is vaccinia?.
        N Engl J Med. 2003; 348: 439-446
      2. Cookson C. Nothing to fear but fear itself and some side-effects. Financial Times. February 1-2, 2003:22

      3. Wlazelek A. Health workers preparing for bio-terrorism. The Morning Call. January 19, 2003;B1:6

      4. 3 of 100,000 react badly to vaccine. The Washington Post. February 14, 2003:A13

      5. Morello C. Experts split on need for terror protection. The Washington Post. February 18, 2003:B1

      6. Connolly C. Focus on smallpox threat revived. The Washington Post. July 17, 2003:A3

      7. Ira Flatow. Interview with Brian Strom, chairman of the Committee on Smallpox Vaccination Program Implementation for the Institute of Medicine [transcript]. “Talk of the Nation/Science Friday.” National Public Radio. April 4, 2003. Available at: http://www.npr.org