3
Vaccine Distribution

Funded by the federal government, vaccine was allocated to states in proportion to the size of their total population, regardless of the disease burden in each state and the number of state residents in the ACIP target groups. Each state then developed its own plan to distribute and administer vaccine. Vaccine was shipped directly to public and private provider vaccination sites from the central distributor, based on orders placed by the states. All healthcare providers who received vaccine shipments had to agree to comply with their state’s requirements for administering vaccine.

States developed many kinds of distribution plans. Some states distributed vaccine to a combination of state and local public health authorities, private healthcare providers, and pharmacies. Other states relied more heavily on local health departments, which then distributed to other stakeholders. A smaller number of states received all the states’ vaccine supply and handled the physical redistribution to vaccine administrators themselves. The diversity in distribution approaches meant that neighboring jurisdictions often had different distribution systems. This caused confusion and communications challenges, some participants noted, especially in states in which each local health department developed its own distribution plan. Some state, city, and county distribution approaches are described in more detail below.

The topic of this section goes hand-in-hand with the topic of the next main section, which is the interpretation and implementation of the ACIP recommendations for target groups. States’ decisions about how to implement the ACIP recommendations heavily influenced their decisions about which stakeholders should receive vaccine. The following hypothetical example illustrates this tight relationship: If a state decided to



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3 Vaccine Distribution Funded by the federal government, vaccine was allocated to states in proportion to the size of their total population, regardless of the disease burden in each state and the number of state residents in the ACIP target groups. Each state then developed its own plan to distribute and adminis- ter vaccine. Vaccine was shipped directly to public and private provider vaccination sites from the central distributor, based on orders placed by the states. All healthcare providers who received vaccine shipments had to agree to comply with their state’s requirements for administering vaccine. States developed many kinds of distribution plans. Some states dis- tributed vaccine to a combination of state and local public health authori- ties, private healthcare providers, and pharmacies. Other states relied more heavily on local health departments, which then distributed to other stakeholders. A smaller number of states received all the states’ vaccine supply and handled the physical redistribution to vaccine administrators themselves. The diversity in distribution approaches meant that neighbor- ing jurisdictions often had different distribution systems. This caused confusion and communications challenges, some participants noted, es- pecially in states in which each local health department developed its own distribution plan. Some state, city, and county distribution ap- proaches are described in more detail below. The topic of this section goes hand-in-hand with the topic of the next main section, which is the interpretation and implementation of the ACIP recommendations for target groups. States’ decisions about how to im- plement the ACIP recommendations heavily influenced their decisions about which stakeholders should receive vaccine. The following hypo- thetical example illustrates this tight relationship: If a state decided to 15

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16 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN focus on vaccinating pregnant women first, they might initially distribute more vaccine to OB/GYNs so they could administer vaccine to their pa- tients, and allocate less vaccine to pediatricians. These issues are dis- cussed in greater detail in that section. The topic of this section is also closely related to the subsequent sec- tion of vaccine administration methods and partners. Unprecedented ef- forts were made during the vaccination campaign to strengthen existing vaccine distribution partnerships and to integrate new partners into the distribution and administration system, particularly for vaccination of pregnant women, other high-risk adults, and children. These partners included healthcare providers, health systems, pharmacies, community organizations, health insurers, and large companies with occupational health clinics, among others. More detailed discussion of the roles of partners, along with the issues they faced during the campaign and poten- tial opportunities to enhance their participation in the future, are dis- cussed in the later section below on vaccine administration methods and partners. Vaccines for Children Program The prototype of the national vaccine distribution strategy was the federal VFC program, through which healthcare providers routinely work with their state and local health departments to provide recom- mended pediatric vaccines to eligible children. McKesson Corporation, the distributor for the VFC program, provided centralized distribution of vaccine directly to the public and private provider sites, as specified in orders from each state. Many workshop participants noted that the infrastructure of the VFC program served as a foundation for their state vaccination distribution programs. Many components of the VFC program were found to be help- ful during the 2009 H1N1 campaign. Some states used or adapted their VFC healthcare provider registration system for provider registration to receive 2009 H1N1 vaccine. Several participants noted that healthcare providers and clinics that participated in the VFC program found it easier to participate in the 2009 H1N1 vaccination campaign because they were already generally familiar with the system. Tiffany Sutter, information and education section chief of the Immunization Branch of the California Department of Public Health, mentioned that it used the VFC customer

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17 VACCINE DISTRIBUTION service system as a hotline for healthcare providers seeking information about H1N1 vaccination. Several workshop participants noted the challenges posed by the lack of a national program for adult vaccination with linkages to the public health system, analogous to the VFC program. With so many new healthcare providers participating in the 2009 H1N1 vaccination pro- gram, they noted, there is an opportunity to work with those providers to build on what has already been started in response to the 2009 H1N1 pandemic. To continue some of the progress, one jurisdiction will be providing some free vaccine in the fall of 2010, although it most likely will not be sustainable in future years because of uncertain funding. Disbursed State Distribution Models A variety of state, city, and county distribution approaches described below give an overview of the different approaches and the decisions that were made and highlight aspects of approaches that participants identified as being particularly successful. This section is not meant to be a comprehensive review of state and local plans. Tennessee: Susan Cooper, Tennessee’s health commissioner, shared the model that was used in her state. In early spring and through the summer, the state brought together all of the interested parties to create a plan that would best serve the needs of the state as a whole. The state used the existing web-based immunization system for its VFC program as a starting point to preregister healthcare providers who would offer 2009 H1N1 vaccine. The state also reached out to healthcare providers not already participating in the system. When providers registered, they provided practice information so that the state could create an estimate of how to reach high-risk patient populations. The process also collected information on vaccine storage capabilities and ship-to sites. Tennessee also worked through existing relationships with the pharmacy association and the board of pharmacy to engage chain and independent pharmacies; in Tennessee, the Board of Pharmacy allows trained pharmacists to vac- cinate anyone over age 3. Large employers with occupational health clin- ics (which had the necessary systems to maintain cold storage of vaccine) and health clinics located at Tennessee’s colleges and universi- ties were also engaged in these discussions.

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18 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Preregistration in the system did not guarantee receipt of vaccine, nor did registering practices uniformly want to receive vaccine, but it did allow the state to create a road map for distribution. “As the vaccine be- came available, it allowed us to strategically make some decisions about how the distribution would go,” Cooper said. As noted above, vaccine was shipped directly to healthcare provid- ers, hospitals, and pharmacies, according to the state’s instructions. Pri- vate healthcare providers had vaccine shipped directly to their offices. For chain pharmacies in Tennessee, instead of shipping to 100 locations, the vaccine was shipped to the pharmacy’s central distribution point, where it was distributed through the pharmacy’s regular distribution channels across the state. Tennessee’s vaccine registry and provider preregistration program were also adapted to preposition Tamiflu and other countermeasures across the state. The system was built to accommodate the distribution of other stockpiled countermeasures in future events (e.g., antibiotics in case of an anthrax attack). The system also included a tool that allowed healthcare providers, in real time, to publish information about the type of vaccine available at a given site, whether it was for the practices’ pa- tients or the public, whether an appointment was needed, and whether a cost was associated with vaccine administration. “We could have clinics set up within 2 hours of receipt of any vaccine within our public health system, and get that information out in real time,” Cooper noted. North Carolina: Amanda Fuller of the North Carolina Department of Health and Human Services described the state’s distribution system. In the state, 85 local health departments and a federally recognized tribal nation selected the healthcare providers in their areas to receive vaccine. The state delegated this decision because it believed local health depart- ments have the greatest understanding and knowledge about their health- care providers and communities. North Carolina also relied heavily on pharmacies for vaccine admini- stration. The state limited the number of ship-to sites by having vaccine shipped directly to pharmacy chains and healthcare systems, which then distributed the vaccine to their locations. Pharmacies knew which of their pharmacists were able to vaccinate, allowing for a rational and efficient distribution of product. Having a single point of distribution meant that the state had a single point of contact with each company, limiting con- fusion. The role of pharmacies in vaccine distribution and administration

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19 VACCINE DISTRIBUTION is discussed in more detail in the section below on vaccine administration methods and partners. California: California took advantage of large statewide health plans such as Kaiser Permanente, which provides insurance for roughly 15 percent of the state’s population. “We did deliver directly to Kaiser, and they took responsibility for distributing it,” said Horton of the California Department of Public Health. The plan worked so well it may be used again. California also developed a parallel system to allow for delivery of vaccine to individual vaccinators who requested less than the 100-dose lots, which accounted for nearly 20 percent of vaccine, Horton said. He added that we “need to rethink that process, and if not eliminate that [100-dose minimum] restriction, at least provide more options.” Los Angeles (LA) County was a direct grantee, so it received vac- cine to cover its population separately from the state. Eighty percent of the vaccine allocated to LA County was distributed to the private sector. The remaining 20 percent went to the county health department for mass- vaccination clinics to target the uninsured, roughly 20 percent of LA’s population. Although both were effective avenues for distribution, this dual system did have problems, said Laurene Mascola, chief of the Acute Communicable Disease Control Program in the LA County Department of Public Health. One problem was that the two simultaneous distribu- tion mechanisms were not equally visible. The high profile of the public program overshadowed the fact that more vaccine was available from private healthcare providers. This led some members of the public who could have received vaccine from their own providers to visit the mass- vaccination clinics. Illinois: Chicago, also a direct grantee, decided to distribute the vac- cine it received to as many facilities as possible. Part of the rationale, explained Julie Morita, medical director of Chicago Public Health, was that her department knew that the vaccination administration sites and healthcare provider offices did not already have systems in place to vac- cinate all of their patients at once. They were given small amounts so that each site and office could get their systems in place and roll vaccine out. Maryland: In Baltimore the city health department received the bulk order and redistributed it through its public health system. The depart- ment had no interactions with private healthcare providers, which were handled separately by the state.

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20 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Centralized State Distribution Models Alaska: Unlike most states, Alaska handled distribution with a cen- tralized approach. It was one of only two states that had only one ship-to site for vaccine for the entire state; the other was South Dakota, another rural/frontier state. Once received in the central location, vaccine was redistributed directly by the state. In Alaska’s case, the choice to use a centralized distribution model was partly because of weather challenges; the health department did not want the vaccine to freeze while in transit to remote areas. The centralized approach also gave the state flexibility to distribute vaccine in response to disease hotspots. This was done twice: once in response to significant disease on the island of Little Dio- mede, population 128, and once in response to the island of Kodiak, which reported school absenteeism of 40 percent during the outbreak. Alaska had four streams of vaccine coming into the state: The state allocation, vaccine for federal employees from the federal occupational health program, vaccine for the military, and vaccine shipped directly to pharmacy chains. Through strong relationships with each entity, the state was able to track where each stream of vaccine supply was headed and take that into account for the state’s distribution plans. Challenges arose in communications and coordination among the en- tities providing the different sources of vaccine, said Sally Abbott, Alaska’s preparedness director. For example, delayed communications from the Indian Health Service (IHS) about vaccine for IHS hospital em- ployees caused complications because IHS employers had already been included in plans for distributing and administering the state’s supply of vaccine. Distributing vaccine to Alaskan oil field workers was a challenge, Abbott noted. With 85 percent of the state budget coming from oil, shut- ting down the North Slope because of 2009 H1N1 would have been dis- astrous for Alaska. But the state could not preferentially send vaccine to ConocoPhillips and BP on the North Slope when there were pregnant women and children elsewhere in the state who needed vaccine. The state decided to treat the oil slope as a community, even though it was not included on any Census tract because workers typically do not reside permanently on the North Slope. Therefore, when vaccine was distrib- uted by population, oil slope workers received the appropriate allocation. The vaccine was still prioritized for target groups: The oil slope has

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21 VACCINE DISTRIBUTION healthcare workers and people who fell into the target groups who needed the vaccine but had no other way to get it. Situational Awareness The inability to fully track vaccine throughout the distribution and vaccine administration system, from manufacturer to administration to the individual, exacerbated the challenges posed by vaccine shortage and complicated efforts to efficiently and equitably distribute and administer vaccine and, in particular, to communicate effectively with the public regarding local vaccine availability. With regard to the distribution sys- tem specifically, some state and local public health authorities, healthcare providers, and pharmacy representatives described problems receiving up- to-date communications about the timing and content of shipments en route to their offices or locations. Some noted that the shipments arrived several days later than expected, or with different amounts or formula- tions than ordered. They noted that even a small amount of advance no- tice provided during the time the shipment was en route would have helped their efforts to plan clinics, set up patient appointments, and de- termine staffing needs. Several participants emphasized the need to en- hance systems for tracking distribution to improve situational awareness. Participants suggested further integrating existing systems and technolo- gies, such as bar coding and electronic tracking, throughout the distribu- tion and administration system to improve the ability to track vaccine. Department of Defense Distribution System The Department of Defense (DoD) has a policy of mandatory influ- enza vaccination for all uniformed personnel, with non-uniformed per- sonnel highly encouraged to receive vaccinations, said Colonel Wayne Hachey, director of preventive medicine in the Office of the Assistant Secretary of Defense (Health Affairs). During the response to 2009 H1N1, DoD received vaccine from three sources: (1) HHS for uniformed personnel, (2) individual states for its dependent population in-country, and (3) the U.S. government civilian employee program for government employees. About a third of all U.S. government civilian employees work for DoD.

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22 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Like the rest of the nation, DoD did not receive vaccine until October 2009, but it quickly ramped up its vaccination campaign, Hachey said. By the end of March 2010, 89 percent of uniformed personnel were vac- cinated, and by the end of April, that percentage rose to the mid-90s. One gap DoD identified was dependents living outside the continental United States. No vaccine source was allocated to them, so vaccine from other areas was redistributed to cover them. The high vaccination rate in the DoD program is easily explained, noted Hachey: DoD does a seasonal vaccination campaign each year, and vaccination is mandatory for uni- formed personnel. Distribution to Tribal Areas Many challenges were associated with vaccination campaigns in tribal areas. The population is young and therefore has a higher percent- age of pregnant women than any other racial/ethnic group, explained John Redd, chief of the infectious disease branch of the IHS Division of Epidemiology and Disease Prevention. He also noted that tribal areas have a high prevalence of diabetes and other comorbidities. The death rate from 2009 H1N1 for American Indians and Alaska Natives (AI/AN) was four times higher than the rate for all other racial/ethnic populations in aggregrate (CDC, 2009b). Recognizing that AI/AN would have high prevalence and risk factors for 2009 H1N1, some states prioritized 2009 H1N1 vaccine for AI/AN, but others did not. Within the Northwest, Oregon, Idaho, and Washington each used different methods of getting vaccine to tribal populations. Oregon dis- tributed vaccine directly to tribes, leaving them to decide about local ad- ministration. In Idaho, local health departments kept the vaccine and held clinics, with the tribal populations invited to participate. In Washington, the state gave the local health departments the vaccine, which was then given to the tribes. Some tribes felt frustration during the vaccination campaign because they believed they were not treated as sovereign govern- ments, but rather as healthcare providers or clinics, reported Joe Finkbonner, executive director of the Northwest Portland Area Indian Health Board. He noted that the tribes wanted more flexibility to develop vaccine distribution and administration plans, including the ability to transfer vaccine to other tribes that had none. Other participants noted the impor-

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23 VACCINE DISTRIBUTION tance of including IHS and tribal entities from the beginning of the plan- ning process. Other challenges arose because IHS healthcare workers and their pa- tients received vaccine through separate distribution systems. HHS di- rectly covered the healthcare workers, but vaccine for the general population was distributed from the jurisdiction in which they were lo- cated. This set up complexities in many sites where IHS operates, Redd noted, particularly in remote tribal sites where the distinction between what would be population vaccine and what would be employee vaccine is difficult, if not impossible, to determine. The 100-dose ordering mini- mums were also difficult because many individual tribes are very small. Finally, tribal elders—like other older adults—were not included in the initial vaccination efforts because they were not included in the priority groups. This was thought to have reduced vaccination rates in some American Indian communities because elders are highly respected role models in their communities. Tribal participants requested flexibility to vaccinate elders in future programs in order to improve vaccination rates throughout their communities. Ancillary Supplies In addition to the free vaccine, the federal government also provided ancillary supplies (e.g., syringes, medical-waste disposal equipment) that were shipped separately from the vaccine. Although participants said that it was very helpful to have auxiliary supplies provided, they also noted problems. Supplies were sometimes inappropriate for their intended use, did not always arrive at the necessary time, and were of varying quality, reported workshop participants. For example, some local health depart- ments and healthcare providers reported receiving sharps containers that were too large to be usable. Ann Salyer-Caldwell, associate director of Tarrant County Public Health in Texas, reported having to dip into the public health department’s own supplies to give vaccinations, which was not a problem until they tried to buy more syringes and found there was a lock on purchasing. Jason Terk, a pediatrician in Keller, Texas, noted, “The promised supplies of syringes and sharps containers did not arrive until much later” than the vaccine.

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24 THE 2009 H1N1 INFLUENZA VACCINATION CAMPAIGN Opportunities for Improving Distribution Systems in Future Emergency Vaccination Campaigns Numerous individual suggestions were made about how distribution systems could be improved in future emergency vaccination campaigns. These suggestions are compiled here as part of the factual summary of the workshops and should not be construed as reflecting consensus or endorsement by the workshops, the Preparedness Forum, or The Na- tional Academies. They are as follows: • Develop better systems for tracking vaccine distribution to ensure improved situational awareness. Integrating existing systems and technologies, such as bar coding and electronic tracking, would improve the ability to track vaccine throughout the distribution system. • Continue to use the Vaccines for Children program infra- structure as a foundation for emergency vaccination distri- bution programs. • Consider developing an immunization program for adults analogous to the Vaccines for Children program. • Include the ability to successfully ship in cold-weather envi- ronments as part of the criteria for awarding distribution contracts. Participants from some of the coldest states noted that on some days, vaccine could not be shipped because of concerns about freezing. They noted that systems that can ship in freezing temperatures exist and should be used. • The federal government should deal directly with tribes (na- tion to nation). • If federal authorities distribute ancillary supplies, they should ensure that the distribution process includes timely delivery of quality ancillary supplies that are appropriate for their intended use.