Pharmacy Planning for Influenza Pandemics Scott Coley Bureau of Immunization NYSDOH June 25, 2017
Overview 2 Background Influenza Publicly Purchased Vaccine Emergency Preparedness Why MOU? Pandemic Assumptions Learning from the Past Why Pharmacies? Benefits MOU Activation How and why? What is the framework? What are Pharmacy and State Responsibilities? Getting Started
Background 3
4 Pharmacists As Immunizers in New York - Current Since December 2008 Immunize ages 18 and older Vaccines currently included: Influenza, pneumococcal, meningococcal, shingles, tetanus, diphtheria, pertussis Training through certificate program offered by pharmacy schools and societies
5 Role in Influenza Immunizations Pharmacists are already important routine immunizers across the United States Approximately 260,000 pharmacists provide vaccinations 20% of seasonal influenza vaccinations of adults are administered in a pharmacy or retail setting Pharmacists would become even more crucial during a pandemic If vaccine were provided in a more timely way, the time to vaccinate the public could be reduced significantly Widespread vaccination at or after the peak of disease would have little impact
6 Influenza: Seasonal and Pandemic Seasonal Influenza (Influenza A and B) One or more subtypes Circulation peaks in winter months by hemisphere Ongoing genetic drift Quadrivalent vaccine developed annually Pandemic Influenza (Influenza A) Emergence of a subtype with minimal population immunity Potential for severe disease and rapid spread Variable disease profile 1918: Young/healthy 2009: Pregnant women and individuals with chronic conditions
7 Influenza Virus Surface proteins Determine immunity Vaccine components Virus Changes Drift: Accumulation of mutations Shift: Reassortment of genome segments Reassortment can lead to a pandemic
8 Mammalian and Avian Hosts Inter-Species infection restrictions Circulation of human subtypes in other animals even if eliminated from humans
Interaction Increases Chances of Reassortment 9
10 Emergence of Pandemic Influenza Virus On the lookout for: Large outbreaks among animals, especially birds, pigs Crossing species barriers Initial human cases Human-to-human transmission As in 2009, may come in waves: First cases seen in April Early peak in May-June Activity began increasing again in late August
Vaccine Development 11
12 New York Public Vaccine (Routine) CDC and NYSDOH purchase vaccine Eligible children under 19 years old recommended vaccines Special adult populations specific vaccines Enrolled providers Provider agreement Storage & handling requirements Dose-level accountability IIS reporting required data: e.g. temperature monitoring, accurate inventory Provider orders Processed by NYSDOH Distributed to end-user by McKesson
13 IIS and Public Vaccine Management Immunization Information System (IIS) reporting Required for immunizations to patients under 19 years With consent for patients 19 and older. Repository for immunizations in New York Citywide Immunization Registry (CIR) in New York City NYSIIS in the rest of New York State Integrated vaccine tracking data Inventory, shipped and received Administration, inventory decremented - Data Exchange Vaccine wastage and expiration, used to coordinate returns Online ordering Inventory data is used to inform order approvals
14 Emergency Preparedness Local (county) Health Departments are responsible for local response LHDs coordinate with partners: CDC, State, Regional, Local Responses involving vaccines and other medications Medical Countermeasures POD: Point of Dispensing LHD agreements with local providers Closed PODs: Medications available for a defined population
15 Antivirals Important medication depending on influenza strain sensitivity Previously available through NYSDOH to pharmacies 2009 H1N1 pandemic influenza response For un-insured/under-insured individuals Federal program Not currently part of the MOU. Expect for the Antiviral Distribution Plan (ADP) to be revived as needed.
16 Why are we talking MOU?
17 What makes pandemic response different? Seasonal flu factors Local public health challenge Peaks in winter Single dose sufficient Antigen only Public and private purchase vaccine Majority of public vaccine for eligible children Public vaccine provided to existing network of enrolled providers Pandemic flu factors Multinational outbreak May last months Multiple doses may be required Antigen + adjuvant (in some cases) Federal government purchase entire vaccine supply Public vaccine for the entire population; Prioritization may be necessary: critical infrastructure and at-risk populations Enhanced recruitment to engage willing providers
18 Other Pandemic Response Assumptions Using existing public vaccine supply mechanisms New York State will utilize all willing and able immunizers New York State and City will have separate allocations Pro-rata County allocations also pro-rata Weekly ordering/allocation
Define the Need 19 Established systems manage other needs effectively: Routine immunization including seasonal influenza: enrolled public providers Local emergency response: contracted closed POD providers (including pharmacies) Pandemic response requirements Efficient startup Engage providers early Ensure preparedness to store and administer vaccine Provide public with broad vaccine availability Current gap Providers with a clear role in immunization without ongoing public vaccine system engagement Pharmacists Adult and specialty providers
20 Think Back to 2009 Recent expansion of pharmacy scope of practice Executive order further expanded scope of practice during the response Pharmacists: immunize all ages. Relatively little vaccine allocated to and administered by pharmacies
21 Now Most pharmacies regularly use NYSIIS No pharmacies are enrolled in VFC Program requirements are increasingly incorporated into NYSIIS Experience Pharmacies can meet increases in demand 2012-2013 Influenza season, emergency declaration
22 Potential Future Pandemic Vaccine Availability: CDC expects greater availability in a shorter period New York needs all capable providers Especially those with capacity to rapidly immunize Expect pharmacies to play a greater role Formal agreements (Memoranda of Understanding) can expedite collaboration
Total # Vaccines Administered (Cumulative) Millions 23 The Bottom Line: Public Health Needs Community Pharmacies to Protect the Public During A Pandemic 250 200 150 100 50 0 80% Adult Coverage With Pharmacies Without Pharmacy 80% Coverage
24 What is the MOU? Template developed by ASTHO and CDC Agreement between NYSDOH and a pharmacy organization Single or multiple locations For use in pandemic response Outlines plans for vaccine collaboration Not legally binding Invoked at discretion of NYSDOH Pharmacy organizations decide whether to act Open to all pharmacies in NYS, except NYC pharmacies
25 How will the MOU help? Improves coordination Lays out a response roadmap BEFORE pandemic hits Involves pharmacies as valued partners Leverages pharmacy infrastructure to deliver vaccine where needed when needed faster and more efficiently Empowers pharmacists to serve patients promptly in crisis Strengthens partnerships for other health emergencies
Specific Benefits: For Public Health 26 Reach full vaccine coverage sooner Ensure equity among all pandemic vaccinators Strengthen partnerships and model approaches for other dispensing and clinical services
27 Specific Benefits: For Community Pharmacies Ensure timely inclusion in response planning Standardize operations and points of contact Develop a distribution approach in advance Educate public health about pharmacy planning and response Use public health infrastructure Reduce waste and improve efficiency Clarify expectations and plan for information sharing
MOU Activation 28
29 What happens when a pandemic hits? Initial identification of a pandemic influenza virus Initiation of pandemic vaccine development U.S. government works with manufacturers to produce vaccines NYSDOH commissioner invokes MOU NYSDOH seeks provider partners, Direct communication to MOU pharmacies and other existing public providers MOU pharmacies decide whether to participate If yes, they sign NYS Pandemic Vaccine Provider Agreement (PVPA) MOU is voluntary PVPA is legally binding
30 In advance Ensure that staff are trained and certified so that they are ready to immunize Familiarize key staff with storage and handling guidance Ensure that information systems are configured to submit IIS data Key IT staff can troubleshoot data submission Inform NYSDOH staff of changes Review any interim guidance that NYSDOH shares
31 Once your organization decides to participate For PVPA organization level: Review site data Immunizer credentials Vaccine manager Assess readiness to comply with storage, handling and IIS requirements Additional guidance distributed & training completed Event specific Storage, handling and IIS IIS training for newly recruited users Estimate storage and administration capacity Weekly ordering once notified of availability Allocation subject to availability, epidemiology, etc.
32 When Orders are Filled Receive and distribute the allocated vaccine Single-site pharmacies: receive at your pharmacy Multiple-site pharmacies Receive at your distribution depot Distribute to your sites Serve patients before, during, after vaccination Conduct medical screenings appropriate for vaccination Provide education materials/instructions as needed Report adverse reactions to HHS Vaccine Adverse Event Reporting System
33 Documentation Use NYSIIS to Log vaccine deliveries Assess timing and type of prior vaccinations Multiple doses may be required Report vaccine administration Can use batch data submission, can submit centrally for all locations Report each dose administered to People under 19 People over 19 with their consent Record doses in aggregate for people over 19 who don t consent Maintain inventory of doses wasted, expired, or distributed to other sites Cite data by each site address
34 Use NYSIIS During Pandemic Response Temperature Monitoring Ordering Inventory Administration Data Exchange Wastage Track program compliance New orders approved ONLY when providers are documenting vaccine administration in NYSIIS
35 What will NYS do? Assist providers in enrollment and training Provide pharmacies with guidance and technical support Manage all vaccine orders Allocate vaccine at least weekly Coordinate with relevant agencies/organizations Manage public information activities Coordinate retrieval of unused vaccine at pandemic s end
36 Non-Patient Specific Orders: Standing Orders Standard authorization for immunizing pharmacist Vaccine type specific Template standing orders are available Immunization Action Coalition, free: www.immunize.org Signed by physician or nurse practitioner practicing in the same or adjoining county Identify those authorized to immunize Named on order Employed or contracted by a named pharmacy entity
37 Do we need standing orders for pandemic flu? YES! Assume that you will need a new standing order specific to the pandemic influenza vaccine. It is possible but not guaranteed that existing influenza standing orders would be sufficient. Previously, blanket standing orders were only issued in New York City
38 What about payment? Pharmacies cannot charge for vaccine/supplies from U.S. gov t Pharmacies can charge for vaccine administration Bill patient insurance if available Out-of-pocket fees: cannot exceed regional Medicare vaccine administration fee If billed to Medicaid: cannot exceed NYS Medicaid administration fee Pharmacies can use EPAP for administration reimbursement if available Pharmacies strongly encouraged to vaccinate all, regardless of ability to pay
To Get Involved 39
40 Next Steps NYSDOH approval of template in the works Contact me Review the template Your organizational leadership Your legal department Discuss any changes or addenda you wish to make Submit signed MOU DOH leadership final review and approval of individual MOU
41 Contact: Scott Coley NYSDOH, Bureau of Immunization Scott.Coley@health.ny.gov 518-473-4437
Questions? 42