Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program (2008)

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Appendix B State Plans T his appendix summarizes a sampling of state plans for the distri- bution and dispensing of antivirals. Plans or descriptions of plans were obtained from the Association of State and Territorial Health Officials (ASTHO) presentations at the committee’s information gathering meetings and from the Institute of Medicine staff’s search of the World Wide Web. State Plans for Mass Dispensing of Prophylaxis State public health agencies have a wide variety of plans and activi- ties for the distribution of antivirals. Some states have plans specific to antivirals, and others are relying on their Strategic National Stockpile (SNS) plans. Most states assume they will use antivirals from the SNS and, if available, from their own stockpiles. States have already spent nearly $300 million to build their stockpiles based on the federal guideline of enough antivirals for one quarter of the population, largely targeted toward treatment. Most states have purchased all or some of their por- tion of the federally subsidized stockpile (enough to treat 25 percent of a state’s population) (ASTHO, 2007). State representatives have expressed concern about the tradeoff states are making to purchase antivirals with a limited shelf-life and uncertain efficacy for pandemic influenza, against   This appendix was compiled by Institute of Medicine staff with guidance from the com- mittee, and it was intended to inform the committee’s deliberations. 99 

100 ANTIVIRALS FOR PANDEMIC INFLUENZA spending public health dollars for interventions for which there is prob- ably more immediate need and that, in some cases, have better efficacy data (IOM, 2007). Most state plans have been revised since the announcement of the federal purchasing contracts in 2006 (although not all are public), and 21 states have already or plan to pre-position antivirals around their state. This year several states will use their Centers for Disease Control and Pre- vention (CDC) public health emergency preparedness grants to develop antiviral distribution plans as part of their priority projects for the year (IOM, 2007). Most state plans can be grouped into one of four models for dis- tribution planning of antivirals. The first model is to take the existing SNS plans and add a distribution plan for antivirals. This would involve using the state as the primary distributor with pre-designated distribu- tion sites. A second model is having a formal agreement with local health departments. The third model involves the pre-positioning of antivirals at hospitals and other health care facilities for the treatment of ill persons and the prophylaxis of certain health care workers. The fourth model being employed by states is use of pre-determined points-of-distribution/ points-of-dispensing systems (PODs) (separate from their SNS plan), and distributing antivirals through those sites (some are considering drive- through distribution sites) (IOM, 2007). Another issue that states need to address is how to work with the private sector. At the January 2008 meeting, the committee learned that eight states outsource storage and material management of their antivi- rals to the private sector. Virginia is incorporating retail pharmacies in its antiviral distribution plan. The Virginia Department of Health has desig- nated a private distributor to work directly with pharmacies to fill daily orders based on maximum allotment of antivirals in the health district. The agency is working with the state pharmaceutical association to solicit participation. In Virginia’s plan, the treatment course would be provided to the patient at no cost, and the health department would track patients receiving medication. A challenge is to ensure that only the target popula- tion receives treatment (IOM, 2007). At the committee’s second meeting, the ASTHO Executive Director presented a preliminary report based on a survey of seven states’ activi- ties in regard to influenza antivirals. Some characteristics common to all seven plans include considerable state and local collaboration; planning for treatment of pandemic influenza, but little planning for prophylaxis; and prioritizing groups for treatment as identified in the 2005 Department   The seven states are Iowa, Missouri, New Mexico, North Dakota, Virginia, Washington, and Wyoming. 

APPENDIX B 101 of Health and Human Services (DHHS) Pandemic Influenza Plan (Jarris, 2008). Examples of SNS-Associated Plans (Washington, New Mexico, Iowa, Missouri, California, Indiana, West Virginia) Washington state’s SNS drug distribution plan is designed to cover all pharmaceutical countermeasures, including antivirals for pandemic influenza. The state-level plan is integrated with 35 local plans (local jurisdictions have primary responsibility for distribution once the state delivers the allocation to them). They are considering four types of dis- pensing sites: (1) alternate care facilities (primary care triage sites), (2) hospitals, (3) home health agencies, and (4) drive-through sites (Jarris, 2008). New Mexico’s distribution plan is strongly associated with the SNS plan, and includes points-of-distribution. Because the majority of its population resides in Albuquerque, the state is considering alternative methods of dispensing such as drive-though clinics, large institutional settings, and Native American casinos. The population is diffuse in the rural and frontier areas, so the focus there is on points-of-distribution (Jarris, 2008). Iowa is planning initial distribution to 23 distribution nodes; counties will pick up their pre-designated allotments at those sites. The state pub- lic health agency is discouraging the use of points-of-distribution. Given Iowa’s many rural areas, local public health agencies have had success in the past with drive-through clinics. All local jurisdictions also have spe- cific plans to reach special needs populations. Iowa has hotlines available to answer public and clinical questions. The state is not considering mail delivery of antivirals (Jarris, 2008). Missouri is planning to distribute SNS antiviral stocks from a cen- tral site to regional locations, and then to local communities. A portion will be reserved by the state for containment, prophylaxis, and use in state-run institutions. Points-of-distribution and drive-through sites are being discouraged. Missouri is partnering with physicians, pharmacists, and other clinicians to dispense antivirals for treatment. According to the Missouri Department of Health and Senior Services (DHSS) plan (2007): LPHAs [local public health agencies] will identify community partners that would be appropriate and willing to dispense this medication with- out charge and to comply with other stipulations set forth by DHSS and the CDC regarding the distribution of subsidized medications. Partners could include hospital pharmacies, retail pharmacies, health care pro- viders, and other facilities with appropriate storage facilities, hours of operation, and staff to dispense the medication. 

102 ANTIVIRALS FOR PANDEMIC INFLUENZA Hotlines are available for people who develop adverse reactions to anti- virals (Missouri Department of Health and Senior Services, 2007; Jarris, 2008). California has addressed antiviral distribution by amending its SNS plan, but has not yet addressed the dispensing aspect. Because it has not yet created a dispensing plan separate from the SNS plan, it expects to make this one of its Priority Projects for the CDC Public Health Emergency Preparedness cooperative agreement. To distribute the state stockpile of antivirals when a pandemic has been declared it plans to push them out to pre-determined local health department locations based on population. It intends to keep 10 percent of these antivirals in reserve and expects to receive antivirals from the SNS concurrently, which will be sent out to the counties (ASTHO, 2008). Each of the 61 local health departments in California is creating its own dispensing plan, which will be based on geographic locations, demo- graphics, and other factors. A state committee is being formed to incorpo- rate private entities and representatives from the local health departments to discuss the various methods for dispensing (ASTHO, 2008). California local health departments are also responsible for getting antivirals to sick individuals within 24–48 hours of symptom onset as well as preventing sick persons from going to dispensing sites. They report that they do not have plans for prophylaxis, since they have no funds available to support this activity (ASTHO, 2008). Indiana’s antiviral distribution plan is part of the state’s SNS plan, so is therefore classified. The state plans to provides security from local law enforcement, and it is receiving support from the state sheriffs association. Distribution of state-stockpiled antivirals will mostly be to health care facilities identified in the plan with the trigger being the first human case of pandemic influenza in the United States. Local health departments will decide what method to use for dispensing (ASTHO, 2008). Indiana is only considering drive-through clinics at this time because they plan to implement social distancing. This model has been tested in the state and is written into its plan as an option to be considered by local health departments. Due to administrative issues, its drive-through clinics have a slower throughput than PODs, so planners are trying to address this. Indiana does not yet have a distribution plan for prophylaxis of household contacts and would like to have additional federal guidance   The Missouri Antiviral Storage and Distribution plan (August 2007) calls for reporting antiviral adverse events to the “DHSS, Department Situation Room by calling 1-800-392- 0272. Specific questions pertaining to medical conditions will be triaged and forwarded to nursing staff via the designated Nurse Hotline for consultation” (Missouri Department of Health and Senior Services, 2007). 

APPENDIX B 103 on prophylaxis for critical infrastructure workers. It also does not know how many antiviral courses to expect from CDC or the trigger point for CDC to distribute them (ASTHO, 2008). West Virginia’s antiviral plan is SNS-associated. Most state-stockpiled antivirals will go to the hospitals. The state public health agency is review- ing local county plans to ensure they are feasible and to determine if antivirals should be pushed to local health departments as would be the case in the SNS plan. West Virginia has determined the state has adequate transportation resources within the state to move antivirals, but can do so using the SNS plan if needed. Prophylaxis may be used based on medica- tion supply for priority groups that are identified by CDC and the state. This determination will not be made until the event takes place and the impact, supply, and other factors can be determined (ASTHO, 2008). Private-Sector Distribution Model North Dakota plans to use the existing commercial supply distribu- tion chain. Vendors are under contract with the state and will distribute the state portion of the federal stockpile once the state’s supply runs out. The private vendor will use commercial shipping such as Parcel Post and United Parcel Service. The primary recipients of antivirals will be phar- macies, hospitals, and clinics. The North Dakota backup plan would use local health agencies instead of the private sector. The state is currently looking into using a telephone triage and prescription system as well as drive-through distribution at banks (Jarris, 2008). Pharmacy-Based Dispensing The Virginia plan was developed under the guidance of the state Pandemic Influenza Advisory Committee/Subcommittee on Antiviral Distribution. In this state, pharmacies will be the primary dispensing sites along with community health centers, health departments, and other health care facilities. The underserved population will be supported by local health departments. Antivirals will be pre-positioned with restock- ing schedules. The Virginia Department of Medical Assistance Services will track antiviral dispensing to prevent misuse of the system. The major barriers that Virginia is facing are how to provide access to care and the requirement for a provider prescription (Jarris, 2008; Virginia Department of Health, 2008). Alabama has approximately a half-million courses of antivirals in the state stockpile, and the state anticipates getting an additional 700,000 through the SNS. To distribute these drugs (in a setting with limited amounts of the drug), when the appropriate trigger is reached, the state 

104 ANTIVIRALS FOR PANDEMIC INFLUENZA plans to “push” its stockpile through the drug distribution channels of the drug wholesalers, hospitals, pharmacies, and physicians, and prob- ably would distribute state supplies directly through community health centers and county health departments. Because of concerns about infec- tion control, the state probably will not use points-of-dispensing sites for treatment unless intended distribution sites were not adequate. However, Alabama would use points-of-distribution for prophylaxis assuming ade- quate supply (Jarris, 2008). New York City Like those of most states, the New York City planning assumptions are similar to those outlined by DHHS. The public health agency is plan- ning for multiple waves of the pandemic with an attack rate of 30 percent, and assumes that about half of those cases would require outpatient care and about 11 percent of those infected would need to be hospitalized, with a case fatality rate of 2 percent (Category 5 of severity on DHHS’s 1 to 5 scale, with 1 indicating the lowest case fatality rate). New York City’s plan- ning also assumes that antiviral supplies are limited, with the expectation that the supply chain may increase. The city expects to receive antivirals from the SNS, the federally subsidized New York state stockpile, and additional state-purchased antivirals to which the city would have access if needed. The city expects 267,000 hospitalizations and 49,000 deaths in a pandemic (Zucker, 2007). As part of its plan, the NY Department of Health and Mental Hygiene has developed draft treatment algorithms and has vetted those with health care partners. The department has iden- tified more than 300 sites for antiviral distribution for treatment of staff, patients, and the public. These sites include hospitals, nursing homes, home health care agencies, and community health centers. The depart- ment is in the process of completing a Memorandum of Understanding for the dispensing sites (Zucker, 2007). It also plans to use existing health care resources and providers, and the fire and police departments. The city plans to distribute to its 68 hospitals on a pro rata basis by number of beds. The city also has 25 federally qualified health centers; the depart- ment intends to divert patients there if the patients do not need hospital- ization to avoid overwhelming emergency departments. The city has not decided whether to pre-position antivirals, and if it does, in what quantities. To track antiviral dispensing (and influenza vac- cine), the New York City Department of Health plans to use the citywide immunization registry (94 percent accountable for the several million doses of pediatric vaccines annually). New York City public health offi- cials do not believe they can track all individuals infected with pandemic 

APPENDIX B 105 influenza, so it is unlikely they can provide post-exposure prophylaxis for all contacts of cases (Zucker, 2007). REFERENCES ASTHO (Association of State and Territorial Health Officials). 2007. ASTHO antiviral survey summary. Washington, DC: ASTHO. ASTHO. 2008. Supplemental information for IOM: State antiviral distribution plans. Submitted by the Association of State and Territorial Health Officials (ASTHO), February 4, 2008. Washington, DC. IOM (Institute of Medicine). 2007. Transcript: Meeting one of the Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Jarris, P. E. 2008. Review of state antiviral distribution plans. Presentation at Meeting Two of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC. Missouri Department of Health and Senior Services. 2007. Pandemic influenza plan— antiviral storage and distribution. http://www.dhss.mo.gov/PandemicPlan/Antiviral StorageandDistribution.pdf (accessed April 29, 2008). Virginia Department of Health. 2008. DRAFT. Virginia Department of Health Pandemic Influenza Plan. Antiviral Drug Distribution and Use, Supplement 7, January 2, 2008. Zucker, J. 2007. NYC DOHMH antiviral planning. Presentation at Meeting One of the Institute of Medicine Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic. Washington, DC.