Pregnant women are at higher risk for complications and adverse outcomes of influenza infection and are included in the U.S. highest priority groups to receive the 2009 H1N1 influenza vaccination. Historically, pregnant women have the lowest vaccine coverage level of all adult population groups recommended to receive seasonal influenza vaccination (14.4% in a 2004 national study). In King County, there are more than 400 obstetric specialists. Most do not routinely administer influenza vaccine in their clinics and are not experienced in working with a monitored vaccine delivery system as required for receipt of 2009 H1N1 influenza vaccine. In contrast, most family medicine providers, public health and community clinics that provide prenatal care participate in the Vaccine for Children (VFC) Program and are seasoned providers of vaccine. A just-in-time system to assure access and encourage acceptance of vaccine by women receiving prenatal care through obstetric specialists was lacking.
Goal: Prevent 2009 H1N1 Influenza in pregnant and birthing women attended by obstetrician-gynecologists (OB) in King County, Washington, through vaccination.
Objectives: 1. Develop and implement a strategy in collaboration with King County hospitals to make H1N1 vaccine readily available to pregnant women who receive prenatal care through OB clinics
2. Improve 2009 H1N1 Influenza vaccination rate over 2004 national seasonal flu vaccination rate of 14.4% in pregnant population receiving prenatal care by King County OB providers Planning with clinic-based OB providers, in collaboration with their affiliated hospitals, for patient access to H1N1 vaccine worked well.
The hospitals became stakeholders in the process, understanding their vested interest in prevention of influenza in women who would eventually become inpatients. The strategy promoted a consistent plan among OB clinics affiliated with that hospital. Public Health was able to build a more reliable database of OB clinics, providers and their particular hospital affiliations. Most OB clinics gained experience with vaccine receipt, storage and record-keeping, which will be helpful with any future mandate for just-in-time targeted medication delivery. In addition, there is early indication that some clinics that have not previously offered seasonal flu vaccine will make it routinely available. All stakeholders learned lessons from their chosen approaches and what they might do differently next time. The original minimum shipment quantity of 100 doses of vaccine was a barrier for participation of birthing centers. Some of their patients had access to vaccine through a primary care provider, while others had to wait until pharmacies were supplied. Early estimates from the State of Washington Department of Health through a statewide sentinel reporting system suggest the vaccination rate for pregnant women averaged 38%. The King County hospital which sponsored on-site vaccination clinics for pregnant women, using a line list of eligible patients supplied by affiliated OB clinics, estimates a vaccination rate of more than 50%.
The public health issue this project addresses is the low rate of vaccine uptake in a population at high risk for a preventable disease. Historically, pregnant women are at higher risk for complications and adverse outcomes of influenza infection. Analysis of data from the spring outbreak of H1N1 influenza indicates that pregnant women were four times more likely to be hospitalized as a result of infection with the flu than was the general adult population. Pregnant women are included in the U.S. highest priority groups to receive the 2009 H1N1 influenza vaccination, in face of a 2004 study that showed that pregnant women had the lowest vaccine coverage level (14.4%) of all adult population groups recommended to receive seasonal influenza vaccination.
In October 2009, the American College of Obstetricians and Gynecologists (ACOG) joined with the American Medical Association, the American Academy of Family Physicians, and the CDC to urge pregnant women to be vaccinated against both the seasonal flu and the H1N1 flu. Potential benefits listed included results of a study of seasonal influenza vaccine that showed vaccination during pregnancy reduced febrile respiratory illness both in the mothers and infants and reduced lab-confirmed influenza in the infants, who are ineligible for vaccine under the age of 6 months. The importance of targeting efforts to promote the safety and efficacy of influenza vaccine and pandemic influenza mitigation strategies through OB providers and facilities providing maternity care is demonstrated in Beigi’s study which showed almost 70% of pregnant women would seek medical information from their OB provider regarding the decision whether to receive a pandemic avian influenza vaccine (Beigi, J Reprod Med, 2009).
The process used to determine that a strategy was needed to target vaccine access to pregnant women cared for by obstetricians in King County included
1) assessment of current vaccine practices of that medical specialty
2) a survey of emergency planning to date in hospital mother-baby units
3) assessment of communication channels with OB providers for just-in-time advisories
4) deliberations of the Washington State Department of Health Perinatal Pandemic Flu Planning Workgroup. In King County, there are more than 400 obstetric specialists.
Most King County OB clinics do not routinely administer influenza vaccine and are not experienced in working with a monitored vaccine delivery system as required for receipt of 2009 H1N1 influenza vaccine. When human papilloma virus (HPV) vaccine became available through the Vaccine for Children (VFC) Program, only a few OB clinics registered as providers and have since dropped out. In contrast, most family medicine providers, public health and community clinics that provide prenatal care are seasoned in vaccine management through years of participation in VFC. Public Health had no reliable up-to-date database of OB providers linked with their affiliated clinics and the hospitals where they practice, even with help from the local chapter of ACOG. There was no just-in-time system to communicate and to activate a response targeted to women receiving prenatal care through obstetric specialists. OB clinics have a strong working relationship with the hospital where their pregnant patients are admitted to deliver. The hospital connection suggested the most reliable communication channel to reach OB providers. Gaps in response planning for pregnant and birthing women and their newborns in health emergencies had been identified through the work of the Perinatal Task Force, one of the active committees of the Pediatric Workgroup of the King County Healthcare Coalition. In a survey conducted by the task force, focused on pandemic flu planning, more than half of hospitals providing childbirth services had no communication plan to relate just-in-time information and advisories to perinatal staff, birthing inpatients and their families or pregnant
Agency Community RolesH1N1 influenza vaccine distribution in King County was the responsibility of Public Health – Seattle & King County (Public Health). The county’s population of pregnant women, having been identified as high-risk priority for vaccination, became the focus of targeted strategic planning, including designation of a staff member at Public Health as coordinator for planning for vaccine distribution to patients of OB clinics. In the 2009 H1N1 vaccine distribution system in King County, all entities receiving H1N1 influenza vaccine placed initial orders and refills either directly to Public Health or indirectly, through their agreed-upon distribution hub, such as an affiliated hospital pharmacy, healthcare network hub or other receiving and storage site. The Vaccine for Children’s (VFC) program, which is the prototype for the H1N1 vaccine distribution scheme, is routinely administered by Public Health, which regularly interacts with family medicine, public health and community clinics that may also provide prenatal services and were already familiar with the process. In this project, OB clinics and their affiliated hospital/healthcare network hub reached an agreement about their individual roles in receipt, storage and vaccine distribution. The minority of OB clinics elected to receive vaccine directly from the national distributor. Another group of OB clinics referred their patients to a series of onsite hospital-sponsored vaccine clinics dedicated to pregnant patients of hospital-affiliated OB medical staff. In most cases, hospitals agreed to serve as a distribution hub, to receive, store and distribute vaccine to their affiliated clinics. Since this was a novel operation for most clinics and hospitals, some troubleshooting was required among clinics and their suppliers, with the help of the vaccine coordinators in Public Health. Most of the glitches were results of the initial and unpredictable limited supply, which necessitated partial shipments to the distribution sites, and the various types of vaccine, some of which were inappropriate for pregnant women. The distribution site in the hub strategy served as a “middleman,” requiring recordkeeping, allocation decisions and skills in public relations. For example, initially, all clinics agreeing to receive and administer vaccine were advised to register for purposes of liability protection and were assigned an individual registration number. When the distribution hub for those clinics received only 10% of its total submitted order under its own registration number, it was initially unclear that the quantity was intended to be divided according to same percentage with its participating clinics.
Costs and ExpendituresPublic Health developed a list of representatives from maternity services of every agency in King County that provides childbirth services (11 hospitals and 3 free-standing birthing centers) and invited them to a planning meeting, hosted by one of the hospitals, to discuss the high-risk nature of their pregnant and birthing patients, the historically low seasonal influenza vaccination rate of this population and various alternatives for vaccine distribution to this group. Public Health also provided suggested educational resources regarding influenza for physicians and patients. Meeting participants included representatives of 10 hospitals and 1 birthing center, several community obstetricians, Public Health planners and the Project Manager of the King County Healthcare Coalition, of which all hospitals are members.
Within a week of the meeting, Public Health sent an electronic questionnaire to the hospital representatives to assess vaccination planning with affiliated OB clinics, which included the following options:
1. Hospital will sponsor vaccination clinics for pregnant patients of medical staff OB providers
2. OB clinics will receive, store and administer vaccine to their own patients
3. OB clinics will administer vaccine to own patients, but hospital (pharmacy) will receive, store and distribute vaccine to the clinics affiliated with the hospital
4. Their own “unique plan” (they were asked to provide details of plan)
Through this survey, Public Health was able to define distribution sites for allocation and delivery of vaccine by the national distributor and to develop systems for tailored access to vaccine for all OB providers affiliated with each hospital. In the early days of limited vaccine availability, Public Health placed follow-up calls to multiple individual clinics to check on vaccine supply and to reassure them that more vaccine was in the pipeline. Additional fine-tuning was required to trouble-shoot problems experienced by some clinics working under Option 3, which included not receiving what they felt to be appropriate allocations from their hospital supplier. Estimated costs were as follows: Planning coordinator: $24,000 (includes benefits) Meeting space (in-kind) Time of meeting attendees and of internal hospital and clinic planning deliberations (in-kind) Time of two follow-up focus groups (in-kind) Time of survey responders (in-kind) The planning coordinator’s salary and benefits were funded through the federal “PHEPR H1N1 Pan Flu Ph III Mass Vac” grant to Public Health-Seattle & King County.
ImplementationObjective1: Develop and implement a strategy in collaboration with hospitals to make H1N1 vaccine readily available to pregnant women who receive prenatal care through OB clinics
• Identify points-of-contact in maternity services for each of 11 hospitals and 3 childbirth centers in King County
• Develop agenda and confirm speakers for planning meeting of regional maternity service providers
• Arrange venue, time, date for vaccine distribution planning meeting
• Send invitation to vaccine distribution planning meeting
• Develop patient and provider educational materials
• Hold regional vaccine distribution planning meeting
• Develop and distribute template for hospital decision re: vaccine distribution options and hospital-associated OB clinic roster; distribute via email to hospital contacts
• Collect distribution plans from hospitals
• Develop data-base with contact information to reflect OB clinic-hospital association and vaccine distribution strategy; cross check with Public Health vaccine distribution plan
• With arrival of initial vaccine shipments to distribution hubs, check with OB clinics who are supplied through this mechanism
• Troubleshoot problems with clinics who feel short-changed (required reeducation of some distribution hubs regarding process)
• Schedule focus groups to assess two types of distribution schemes
• Develop draft of follow-up survey tool
• Conduct focus group # 1 (centralized distribution site)
• Conduct focus group # 2 (hospital-sponsored onsite vaccination clinics)
• Refine survey tool and obtain peer review
• Update email database of OB clinic managers
• Publish survey tool on Survey Gizmo™
• Collect survey responses
• Analyze survey responses
• Create survey report
• Distribute/present survey results to stakeholders
Objective 2: Improve 2009 H1N1 Influenza vaccination rate over 2004 national seasonal flu vaccination rate of 14.4% in pregnant population receiving prenatal care by King County OB providers
• Collect and analyze data re: vaccine utilization by OB providers (local and state public health reports) and cross check with information from hospitals which served as distribution hubs, if available
• Compare vaccine uptake among hospital-related clinics with different distribution schemes through results of follow-up survey
• Compare data with Washington State Pregnancy Risk Assessment Monitoring System (PRAMS) survey, which has added questions regarding seasonal and H1N1 Influenza vaccine uptake since December 2009 and will continue sampling for period of 1 year
Objective 1: August 15-31, 2009: Arrange planning meeting for representatives of King County hospitals with maternity services, select and invite attendees, develop resources, agenda, speakers and conduct meeting. September : Develop, distribute and collect responses of survey of hospitals regarding vaccine distribution planning with affiliated OB clinics with clinic roster; develop database and cross check with Public Health plan. October–December: Track, troubleshoot and facilitate resolution of problems with vaccine distribution to OB clinics and OB patients. January-Feb 2010: Conduct focus groups, develop and refine survey instrument, conduct web-based follow-up survey. March – April: Analyze survey results; create survey report and distribute/present to stakeholders.
Objective 2: January – Feb, 2010: Collect and analyze vaccine utilization data. February – April: Analysis of follow-up survey of OB clinics. January 2011: Compare vaccine uptake data results from survey with PRAMS report.
The overall project goal was prevention of 2009 H1N1 Influenza in pregnant and birthing women receiving prenatal, perinatal and postpartum care by obstetrician-gynecologists (OB) of King County, Washington, through vaccination with 2009 H1N1 Influenza vaccine.
1) Develop and implement a strategy in collaboration with hospitals to make H1N1 vaccine readily available to pregnant women who receive prenatal care through OB clinicsi)Conduct a meeting of maternity service representatives of 90% of King County hospitals that provide childbirth services (N=11) by August 31, 2009 ii)Provide both patient-oriented and provider-oriented vaccine and influenza educational resources to maternity service representatives by August 31 iii) Collect information from each hospital about plans made with associated clinics of obstetric providers on medical staff for vaccine distribution by September 9 iv) Assess function of distribution plans through contact via phone or email to individual OB clinics and associated distribution center after initial shipments and on an as-needed basis v) Obtain OB clinics’ assessments of strategies through focus groups and an anonymous survey in early 2010.
i) Vaccine distribution option selected by each hospital with its affiliated clinics ii)List of OB clinics associated with each hospital, along with contact information iii) Master list of hospitals with affiliated OB clinics and individual roles in vaccine receipt and distribution iv)Focus group of 5 OB clinics that received vaccine through hospital pharmacy as distribution center to assess experience and inform development of survey tool v)Focus group of facilitators of hospital-based vaccination clinics for patients of OB providers on medical staff to assess experience and inform survey tool vi) Electronic survey to assess experience of at least 80% of OB clinics, including estimate of H1N1 vaccine uptake, to be conducted by Public Health in February 2010 vii)Analysis of vaccine uptake by hospital-related distribution system as well by individual clinics will be conducted by Public Health through tracking records, as they become available
i) Vaccine distribution options and lists of OB clinics affiliated with hospitals were collected through September 2009 ii) Problems with vaccine distribution required fine-tuning of lists of OB clinics associated with a few large hospital systems in October-November 2009 iii) Electronic survey will be published in early February 2010 iv) Analysis of vaccine uptake tracking records will be conducted as soon as data becomes available.
i) Many clinics would have preferred direct shipment, but could not use and /or store the initially required minimum shipment of 100 doses ii) Some hospital-based distribution centers did not include OB clinics in initial distribution for several reasons: confusion regarding partial shipments and when hospital-associated clinics should receive a pro-rated percentage of the total order, pressure from internal hospital departments for vaccine, failure to create a practical and transparent allocation and tracking system. iii) System challenges: (1) Insistence on thimerosal-free formulation for pregnant women (2) Confusion regarding ordering, submitting refill requests and tracking. (3) Nasal spray (first formulation available) was rejected by many healthcare workers for perceived safety concerns (“not as protective,” “may pose risk to patients”), age limitations or health risk factors, so although a priority group, many OB healthcare providers themselves were unvaccinated initially.
i) 100% of King County hospitals that provide childbirth services collaborated with their affiliated OB clinics to make H1N1 vaccine available to their patients during the 2009-2010 flu season ii) This outcome was intended and short-term, in view of its resulting from a strategic response to a specific vaccine distribution issue.
The Perinatal 2009 H1N1 Influenza Vaccination Project is a just-in-time response to 2009 Pandemic Influenza (H1N1) targeted at closing a long-recognized gap in seasonal flu vaccination of the pregnant population. We have achieved our first objective, to make H1N1 vaccine available to pregnant women who receive prenatal care by OB specialists. This outreach raised the awareness of both OB patients and providers of the vulnerability of pregnant women to the risk of complications from influenza. If the pregnant population indicates a continued demand for routine access to vaccination through their OB clinics, pregnant women could certainly have an impact on sustainability as a stakeholder group.
Public Health would like to see administration of vaccines by OB providers become routine, not only for influenza, but also for other preventable communicable diseases, not only for the sake of the mother-to-be, but also for the vulnerable newborn and other high risk contacts of the mother-to-be. The OB community should have a new confident vision of their role as designated primary care providers by many women and their responsibility to provide preventive counsel and interventions, such as vaccines, as part of a medical home. The fact that the OB community accepted a new standard of care for this pandemic emergency may make it easier for them to add vaccination to their routine practice. We plan to assess the individual experiences of OB clinics in their role as vaccinators, including their plans for next year’s influenza season, and will provide the survey results to the obstetric and hospital community to stimulate early planning conversations. As a result of this project, communication channels between Public Health and the OB community have been strengthened.
Public Health now has a more reliable database of OB providers, their clinics and their affiliated hospitals to be able to communicate alerts and advisories that may impact their delivery of healthcare, particularly in areas that specifically affect pregnant and birthing women. In turn, Public Health will be able to receive more information from the OB community regarding their concerns and needs as healthcare providers for a special patient population. In addition, communication among OB clinics and their associated hospitals has been reinforced, not only at the OB specialty section level, but also with hospital pharmacy and executive leadership, who were involved in vaccine delivery planning decisions. The King County Healthcare Coalition Pediatric Perinatal Taskforce, having already identified the gap in preparedness for any medical emergency that impacts pregnant and birthing women and their newborns, will continue to meet and plan on a regular basis to tackle related issues, including the results of the assessment of outcomes of this project. The responses to a question on the follow-up survey, “As a result of the H1N1 vaccination experience, will you consider changing your clinic’s current practice of seasonal flu vaccination in the fall of 2010?” will help to inform that work.