WHEREAS, this MOU is intended to supplement, and not supplant, existing local level plans and distribution strategies;

Transcription

1 1 Memorandum of Understanding between New York State Department of Health ( NYSDOH ) and [INSERT PHARMACY NAME]( PHARMACY ) for the Coordination of a Pandemic Influenza Vaccination Campaign in Planning for and Responding to An Influenza Pandemic This Memorandum of Understanding ("MOU"), made as of [insert date], sets forth the terms of an understanding between New York State Department of Health ("NYSDOH"), having its primary offices at Empire State Plaza, Corning Tower, Albany, NY and [INSERT PHARMACY NAME] ("PHARMACY "), having its primary offices at [insert address], each a Party and, collectively, the Parties. WHEREAS, coordination between public sector health programs and private sector pharmacies in pandemic influenza planning and response will be essential to expanding public access to influenza pandemic vaccination during the next influenza pandemic; WHEREAS, this MOU is intended to supplement, and not supplant, existing local level plans and distribution strategies; WHEREAS, the purpose of the MOU is to set forth a framework for the utilization of the existing infrastructure of pharmacies to assist in rapidly providing pandemic influenza vaccinations to the general public during an influenza pandemic; WHEREAS, PHARMACY acknowledges that executing this MOU does not guarantee that PHARMACY will receive vaccine during a pandemic outbreak; and WHEREAS, the Parties acknowledge that this MOU sets forth intended mutual and voluntary cooperation and is not intended to be a legally binding contractual agreement. NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this MOU, the receipt and sufficiency of which are hereby acknowledged, the Parties agree to the following: I. DEFINITIONS A. Authorized Representative. Person or persons authorized by NYSDOH to request, or by PHARMACY to assist in distributing and administering, pandemic vaccine and to serve as the primary point of contact for other communications, unless otherwise agreed upon. Such representatives and their contact information shall be annexed to this MOU as Attachment A. B. Influenza Pandemic. Sustained human to human transmission of a novel influenza A virus and infection across multiple countries and continents.

2 2 C. New York State Immunization Information System. Confidential, web based state wide database, which maintains immunization doses administered by providers in a manner that is consistent with Public Health Law (PHL) section 2168 and associated regulations. This system is also used to manage vaccine inventory for all publicly supplied vaccines. D. Pandemic Vaccine. Vaccine product as established and defined by the United States Department of Health and Human Services (HHS). E. Pandemic Vaccine Ancillary Supplies. Vaccine syringes, needles, vials, shot cards, and all other supplies utilized for vaccine administration of pandemic vaccine, excluding sharps containers. These supplies are included with vaccine shipments F. Pandemic Vaccine Provider. Any provider designated by the Centers for Disease Control and Prevention (CDC) and/or state and local immunization programs to receive pandemic vaccine and ancillary supplies from the CDC or its contracted distributor during the pandemic response. Pandemic vaccine providers may include pharmacies, which may have multiple provider locations. G. Pandemic Vaccine Provider Agreement Form. A standard agreement form which will be issued at the time of a pandemic event by NYSDOH setting forth the terms to which pandemic vaccine providers must agree and sign in order to receive publicly purchased vaccine. Pandemic Vaccine Provider Agreement form terms may include, but not be limited to, the following terms: requirements for vaccine ordering, storage and handling, eligibility screening (if applicable), reporting of vaccine inventory and of doses administered, expired, and wasted, and compliance with all relevant state and federal law. Such terms will be based upon the factors known at the time of the event and address the specific influenza pandemic situation as well as any current response strategies and capabilities. H. Secondary Distribution. For the purposes of this MOU, secondary distribution means the distribution of pandemic vaccine from a PHARMACY designated depot to individual sites as agreed upon by NYSDOH, which may be completed by PHARMACY s existing distributor and/or vaccine wholesalers. II. ASSUMPTIONS A. The federal government will directly contract with vaccine manufacturers to develop, fill, and finish all pandemic vaccine orders, as well as contract with other entities for the provision of ancillary products. B. NYSDOH will manage all pandemic vaccine provider site orders and will make allocations to individual PHARMACY sites on a regular basis, as determined by NYSDOH and subject to the conditions set forth in this MOU, once vaccine is available.

3 3 C. As it is anticipated that the New York City Department of Health and Mental Hygiene (DOHMH) will receive its own allotment of vaccine from the federal government during an influenza pandemic, the scope of this MOU is limited to vaccine allocation, distribution, and administration outside of New York City. D. Where applicable, formal agreements between LHDs and individual pharmacy sites are not superseded by this MOU or any subsequent pandemic vaccine provider agreement forms. E. CDC s Advisory Committee on Immunization Practices (ACIP) will develop recommendations on use of pandemic influenza vaccine products. F. CDC may use an option in the Vaccine for Children (VFC) program s vaccine distribution contract to distribute pandemic influenza vaccine products to pandemic vaccine providers. III. GENERAL RESPONSIBILITIES OF PARTIES A. Planning. NYSDOH and PHARMACY agree that planning for vaccination through PHARMACY will be done jointly and will occur as part of existing pandemic planning activities and before a specific influenza pandemic threat is identified. PHARMACY further agrees that it will coordinate with NYSDOH to ensure statewide consistency with the implementation of specified items, which include, but are not limited to, the following: screening forms, educational materials, billing, and training. B. Activation. 1. If the NYSDOH Commissioner, in consultation with the Division of Epidemiology and the Office of Health Emergency Preparedness, makes a determination to disseminate pandemic influenza vaccine to PHARMACY, a NYSDOH authorized representative may request assistance of PHARMACY by contacting the authorized representative of PHARMACY. Such requests may be oral or written. If oral, the request shall be confirmed in writing as soon as possible. 2. A Pandemic Vaccine Provider Agreement form shall be executed before PHARMACY receives any vaccine or ancillary supplies. a. PHARMACY should review such form at the time of the event, in conjunction with the executed MOU, and, if PHARMACY agrees with the terms, a PHARMACY representative, who has the legal authority to sign for PHARMACY, shall execute the form. b. An executed Pandemic Vaccine Provider Agreement form shall become an attachment to this MOU. Where any terms in the Pandemic Vaccine Provider Agreement form differ from such terms in this MOU, execution of such form will be considered an amendment of the MOU, as set forth and subject to the requirements in Section XVII of this MOU. c. Failure to comply with the requirements of an executed Pandemic Vaccine Provider Agreement form (or the MOU) may result in the denial of subsequent pandemic vaccine orders and the termination of this agreement as set forth in Section XIII of this MOU. IV. TRAINING, LICENSURE, AND CERTIFICATION

4 4 A. Responsibility of PHARMACY. PHARMACY will prepare for a potential pandemic event by ensuring that all pharmacists and other vaccinating personnel employed or contracted by the PHARMACY will: 1. Complete vaccine storage and handling training, as well as NYSIIS training, as needed. 2. Agree to review and adhere to any of CDC s ACIP vaccine recommendations. 3. Complete any other training as determined necessary by NYSDOH. 4. Be appropriately licensed and certified to administer vaccines in New York State. B. Responsibility of NYSDOH. NYSDOH will provide technical assistance, training materials, and other resources, as available, to assist PHARMACY in providing the appropriate training and certifications, as required by NYSDOH, to all pharmacists and other vaccinating personnel employed or contracted by PHARMACY. NYSDOH will provide event specific resources prior to and/or during an influenza pandemic, if available and where feasible. V. PANDEMIC VACCINE PRODUCT ALLOCATION A. Overview of Allocation. 1. NYSDOH will manage all pandemic vaccine orders and make allocations on a regular basis, as determined appropriate by NYSDOH, and as set forth in subdivision (B) of this section. 2. PHARMACY will be considered a single ordering entity (to include any and all of its immunizing locations within New York State), and will be reflected as such in NYSDOH s overall vaccine orders to CDC. B. Allocation to PHARMACY by NYSDOH. During an influenza pandemic, allocation of pandemic vaccine from NYSDOH to PHARMACY may be based on: 1. Availability of pandemic vaccine, as allocated to NYSDOH. Where pandemic vaccine supply is limited and/or where vaccine is allocated pursuant to federally recommended vaccine priority groups, NYSDOH will confer with local health departments (LHDs), pharmacies, and other pandemic vaccine providers according to local prioritization determinations made by LHDs. 2. Epidemiology of the influenza pandemic. 3. Relative county population for pro rata vaccine allocation. 4. PHARMACY capacity, as reported by PHARMACY after NYSDOH initiates response to a recognized pandemic threat. PHARMACY shall provide NYSDOH with an estimate of the number of pandemic vaccines: a. It can store; and b. Staff can administer per week or day, including the minimum, maximum, and typical numbers of vaccines which can be administered. 5. Location of PHARMACY sites and need for geographic distribution to ensure public access to pandemic vaccination points, as determined by NYSDOH. 6. Capacity of other pandemic vaccine providers to administer pandemic vaccines. 7. Potential need to vary pandemic vaccine provider allocations based on vaccine prioritization guidelines for special populations.

5 5 8. Any other method of allocation NYSDOH in its discretion deems appropriate to best protect public health, in accordance with any federal guidelines. C. Allocation to PHARMACY sites 1. Responsibility of PHARMACY. PHARMACY, their contracted vaccine distributor, or designee will be responsible for allocating pandemic vaccine to individual PHARMACY sites within New York State outside of New York City as defined in Section I of this MOU from each allocation made to PHARMACY by NYSDOH. PHARMACY s authorized representative will work in collaboration with NYSDOH in planning for vaccine allocation to sites based on the factors set forth in paragraph (B) of this section. 2. Responsibility of NYSDOH. NYSDOH acknowledges and agrees that it intends to share information with PHARMACY s authorized representative, as needed and authorized under state and federal law, in order to work collaboratively with PHARMACY in making determinations about allocations to individual sites or regions of the New York State. VI. PANDEMIC VACCINE PRODUCT SECONDARY DISTRIBUTION A. PHARMACY acknowledges and agrees to the following: 1. Once pandemic vaccine has been distributed to PHARMACY or its designated depot, PHARMACY and its designees are responsible for any subsequent distribution of pandemic vaccine to PHARMACY s individual sites, as agreed upon by NYSDOH. 2. PHARMACY shall disclose to NYSDOH the location of its designated depot(s) for distribution to sites covered by this MOU. Such information shall only be released by NYSDOH in accordance with the terms set forth in Section XI of this MOU. 3. Pandemic vaccine allocated to PHARMACY by NYSDOH shall not be distributed outside of New York State, nor to sites in New York City, unless authorized by NYSDOH and allowable by the federal government. VII. TRACKING A. Tracking of Pandemic Vaccine Distribution 1. NYSDOH responsibilities. NYSDOH will be responsible for receiving and managing vaccine orders and allocation within New York State, excluding New York City. 2. PHARMACY s responsibilities. a. Upon receipt of a delivery of pandemic vaccine, PHARMACY shall review and accept the delivery in the NYSIIS inventory module. PHARMACY, through its authorized representative, will share data with NYSDOH on pandemic vaccine distributed to other sites within PHARMACY s organization, as requested by NYSDOH. b. When pandemic vaccine doses are distributed from one PHARMACY site to another, each PHARMACY site shall track doses distributed in NYSIIS as follows: the original site shall decrement the doses from its NYSIIS inventory and the receiving site will add the doses to its own NYSIIS inventory. c. In accordance with any terms set forth in a Pandemic Vaccine Provider Agreement form, maintain an up to date public vaccine inventory in the NYSIIS inventory module, including

6 6 accounting for doses wasted, expired, or distributed to other PHARMACY sites, as set forth in subparagraph (b) of this paragraph. 3. Additional tracking requirements. Any additional tracking requirements may be incorporated into the Pandemic Vaccine Provider Agreement form, as determined necessary by NYSDOH. B. Tracking of Pandemic Vaccine Administration 1. PHARMACY responsibilities. a. PHARMACY will ensure that all vaccinations are reported in accordance with current state law and that public vaccine is tracked as required by this MOU and the Pandemic Vaccine Provider Agreement form. b. In accordance with Public Health Law section 2168, ensure that all doses administered to persons less than 19 years of age are reported to NYSIIS; and for persons 19 years of age and older, report all doses administered to NYSIIS provided consent is obtained. Where vaccine is administered to persons 19 years of age and older who do not consent to NYSIIS reporting, PHARMACY shall ensure the NYSIIS inventory module is used to account for such doses on an aggregate basis, where such accounting does not reveal the identity of the vaccine recipient. c. Ensure vaccine usage is reported to NYSIIS at least weekly, unless otherwise requested by NYSDOH. Failure to account for doses administered or to maintain an accurate inventory may result in a denial of future orders and termination of this MOU, as set forth in Section XIII of this MOU. 2. NYSDOH responsibilities. a. At NYSDOH s discretion, submission of data to NYSIIS may instead be made through the Countermeasure Data Management System (CDMS) by pharmacies that have established submission capacity. b. NYSDOH will communicate additional event specific reporting requirements to pharmacies, as applicable. VIII. MEDICAL SCREENING AND VACCINE ADMINISTRATION A. NYSDOH Responsibilities. 1. Provide guidance and technical assistance to PHARMACY regarding screening and administration of pandemic vaccines, including, but not limited to, where there is prioritization of specific patient populations or where multiple pandemic doses or mixing with adjuvant are required. 2. Provide medical screening forms to PHARMACY as guidance in implementing pandemic vaccine administration. 3. Provide additional materials electronically, as applicable, to PHARMACY for the purposes of distributing to all persons during an influenza pandemic, including, but not limited to, the Vaccine Information Sheet (VIS) (if available), appropriate documentation for Emergency Use Authorizations (EUAs) or Emergency Use Instructions (EUIs) and any other documentation issued pursuant to other FDA emergency use authorities. B. PHARMACY Responsibilities

7 7 1. Ensure that pharmacists and other applicable healthcare providers employed or contracted by PHARMACY administer pandemic vaccines in accordance with New York State law. 2. Use NYSIIS to assess time and type of prior vaccination, if applicable. 3. Ensure that the terms of the Pandemic Vaccine Provider Agreement form are adhered to, as well as any additional event specific state or federal guidance or requirements, including, but not limited to: a. Requirements pursuant to an EUA or another FDA emergency use authority, if applicable. b. Vaccine prioritization requirements, when and if applicable. c. Vaccine indications and contraindications. d. Assessment of timing and type of prior pandemic vaccine administered (if multiple vaccine doses are required) for each person presenting for pandemic vaccination. Assessment of prior pandemic vaccine history shall be made through NYSIIS at the point of administration and then, if necessary, by other any other means, such as through the patient s individual shot card. e. Mix vaccine antigen and adjuvant at the point of administration (if needed), and match the vaccine antigen and adjuvant type between vaccine dose one and vaccine dose two (if required). 4. Properly handle and store influenza vaccine as directed by NYSDOH, the Food and Drug Administration (FDA), and any CDC guidance on storage, handling, and temperature control. 5. Provide education materials (e.g., VIS, any fact sheets associated with an EUA, or EUI, if applicable) to all persons receiving pandemic vaccination. 6. Report any pandemic vaccine adverse events following vaccination to the Vaccine Adverse Event Reporting System ( , 7. Exercise all other necessary skills and duties required by NYSDOH for patients to safely receive proper and effective vaccinations. IX. VACCINE COST AND PAYMENT A. During an influenza pandemic, where the federal government directly contracts with vaccine manufacturers to develop, fill, and finish all pandemic vaccine orders, as well as contracts with other entities for the provision of ancillary products, PHARMACY: 1. Is prohibited from charging patients, health insurance plans, or other third party payers for the cost of the vaccine or ancillary supplies provided at no cost to the PHARMACY. 2. May charge a fee for the administration of the vaccine to the patient, their health insurance plan, or other third party payer. If the out of pocket administration fee is billed to Medicaid, the amount billed shall not exceed the State Medicaid administration fee, if one exists. PHARMACY is strongly encouraged to administer pandemic vaccines to all patients seeking vaccine at their sites regardless of ability to pay the administration fee, consistent with any applicable vaccine prioritization guidelines issued at the time of an event. 3. May use the Emergency Prescription Assistance Program (EPAP) for administration reimbursement, where applicable, if the federal government activates EPAP for this purpose. 4. Is prohibited from selling the vaccine or ancillary supplies to any third party.

8 8 5. Neither NYSDOH nor PHARMACY will charge the other Party any fee, or seek reimbursement for any costs associated with or related to the implementation of this MOU, except as expressly set forth herein. X. COMMUNICATION A. NYSDOH Responsibilities. 1. Provide PHARMACY with information, as NYSDOH determines legal and appropriate, regarding pandemic influenza emergency response, including, but, not limited to the following: fact sheets, electronic newsletters, and alerts. 2. Provide timely updates to PHARMACY regarding vaccine allocations and changes in guidance on pandemic vaccine prioritization. 3. Manage public information activities with regard to the overall health and medical response across New York State, including public identification of pharmacies participating in such response pursuant to this MOU. 4. As applicable, coordinate with the New York State Board of Pharmacy and the Pharmacists Society of the State of New York (PSSNY) in advance of a pandemic. 5. Ensure communication with NYSDOH s incident command structure and the emergency operations team or other such designated team for the influenza pandemic response. B. PHARMACY Responsibilities. 1. Update contact information with NYSDOH, as needed. 2. Participate in all planning discussions and exercises with NYSDOH, as requested. 3. Coordinate with the New York State Board of Pharmacy and PSSNY, as applicable. XI. PUBLIC RELEASE OF INFORMATION A. Freedom of Information Law Request. In the event that NYSDOH receives a request under the New York State Freedom of Information Law (FOIL) for PHARMACY s distribution network, NYSDOH will notify PHARMACY in a timely manner of such request. Consistent with the procedures set forth in Public Officers Law (POL) section 89(5), PHARMACY may, within ten (10) business days of its notification by NYSDOH, submit a written request for NYSDOH s consideration, which sets forth (1) what information the PHARMACY believes should be excepted from public disclosure; and (2) the reasons why such information should be excepted, per the exceptions set forth in POL section 87. NYSDOH will make a final determination on what information may be publicly disclosed consistent with POL. B. Subpoena, Court Order, or other Compulsory Process for Non Public Information. In the event NYSDOH receives a subpoena, court order, or other compulsory process to release PHARMACY s distribution network, NYSDOH will contact PHARMACY in a timely manner and take appropriate legal measures, as determined by NYSDOH, to protect such information. NYSDOH will not release the such information until PHARMACY has determined, within a reasonable timeframe, whether to take legal measures to prevent disclosure of such information and has notified NYSDOH of its determination in a timely manner.

9 9 C. PHARMACY Disclosure of Data or Information. 1. PHARMACY shall comply with all applicable state and federal laws related to protected health information. 2. Unless approved by NYSDOH, PHARMACY shall not disclose any other information received by PHARMACY from NYSDOH, where NYSDOH has determined such information to be confidential. XII. DEMOBILIZATION A. Unused vaccine. NYSDOH and PHARMACY will coordinate for NYSDOH s retrieval and/or disposal of any unused pandemic vaccine from PHARMACY sites in accordance with any applicable state and/or federal guidelines. B. Securing unused vaccine. PHARMACY shall secure any unused pandemic vaccine until such time when NYSDOH can provide arrangements or directives for recovery or disposal. XIII. TERM AND TERMINATION A. Effective Date. This MOU shall become effective immediately upon its execution by PHARMACY and NYSDOH. B. Term. This MOU shall remain in effect until participation is terminated by either party to this MOU. C. Termination without Cause. Either party may terminate this MOU by providing written notification to the other party no less than thirty (30) calendar days in advance of the termination date. Where PHARMACY terminates this MOU, it shall return remaining vaccine products in a manner and within a timeframe, as established by NYSDOH. D. Termination for Cause. PHARMACY s breach of a material provision of this MOU or any applicable Pandemic Vaccine Provide Agreement form provision may result in immediate termination of this MOU, including suspending vaccine supply and compelling PHARMACY s return of any remaining vaccine products in a manner and timeframe established by NYSDOH. XIV. LIABILITY A. Each party to this MOU shall be responsible for its own acts and omissions and those of its officers, employees, and agents. No party to this MOU shall be responsible for the acts or omissions of entities not a party to this MOU. Neither party agrees to release, hold harmless or indemnify the other party from liability that may arise from or is related to this MOU. B. Section 319F 3 of the Public Health Service Act (42 U.S.C. section 247d 6d), as enacted by the Public Readiness and Emergency Response Act ( PREP Act ) (Pub. L. No ), may provide additional

10 10 liability protections for actions carried out under this MOU, where a PREP Act declaration is made by the U.S. Secretary of Health and Human Services. XV. WAIVER A. Any waiver by NYSDOH of any act, failure to act or breach on the part of PHARMACY shall not constitute a waiver by NYSDOH of any prior or subsequent act or failure to act or breach by PHARMACY and shall not be effective unless set forth in a written document executed by NYSDOH. XVI. MERGER CLAUSE A. This MOU and any attachments annexed hereto, as referenced herein, constitute the entire understanding of the parties and merges all prior discussions, agreements or understandings into it. No prior agreement, oral or otherwise, regarding the subject matter of this MOU shall be deemed to deemed to exist or bind any of the parties. XVII. AMENDMENTS A. This MOU may be amended by written and signed mutual agreement of the authorized Parties to this Agreement. It may not be altered, modified, rescinded, or extended orally. XVIII. NON ASSIGNMENT CLAUSE A. Neither party may assign this MOU, or any interest in this MOU, without the prior written consent of the other party. XIX. NO THIRD PARTY BENEFICIARY A. Nothing express or implied in this MOU is intended to confer, nor shall anything herein confer, upon any person other than the Parties, any rights, remedies, obligations, or liabilities whatsoever. XX. ADDITONAL PROVISIONS A. Operational Plan Review. This MOU will be reviewed at least annually by one (1) NYSDOH representative and one (1) PHARMACY representative. This MOU and its implementation will be formally reviewed following its use during an influenza pandemic and applicable recommendations from an after action report (AAR) will be incorporated into this MOU. B. Jurisdiction, Venue, and Applicable Law. This MOU shall be governed, construed, applied and enforced in accordance with the laws of the State of New York (without regard to choice of law or conflict of law principles) and the laws of the United States, where applicable.

11 11 C. Severability. If any provision of this MOU is found by a proper authority to be unenforceable or invalid, such unenforceability or invalidity shall not render this MOU unenforceable or invalid as a whole, and, in such event, such provision shall be changed and interpreted so as to best accomplish the objectives of such unenforceable or invalid provision within the limits of applicable law or applicable court decisions. D. Authority to Sign. Each Party signing this MOU, represents that it has the legal authority to enter into this MOU. IN WITNESS WHEREOF, the Parties hereto have executed this MOU as of the day and date first written above. New York State Department of Health Sally Dreslin, M.S., R.N. Executive Deputy Commissioner Signature Title <Insert PHARMACY name> <Insert Name> <Insert Title> Signature Title