This Memorandum of Understanding ("MOU") sets forth the terms of an understanding between Minnesota Department of Health ("MDH"), 625 Robert Street North, St. Paul, MN 55164-0975, and
______ ("Pharmacy"),
______, for the purposes of coordinating medical countermeasure (MCM) dispensing and administration.
I. Introduction & Purpose
In emergencies such as terrorist attacks or pandemics, large numbers of people may be exposed to disease-causing germs. MCMs are medicines (e.g., antibiotics, antivirals, or antitoxins) that may be given in support of treatment or as prophylaxis (oral or vaccination) to the identified population in accordance with public health guidelines or recommendations. Lives may depend on dispensing MCMs to a large number of people in a short amount of time.
In such an emergency, MDH can request large quantities of MCMs from the Assistant Secretary for Preparedness and Response (ASPR). ASPR maintains a large cache of MCMs called the Strategic National Stockpile (SNS), which can be quickly mobilized for emergency distribution. MDH then works with partners to dispense the MCMs to the health care system and the public directly.
Coordination between public health programs and private sector pharmacies in planning and response is essential to expanding access to MCMs during a public health emergency. Improved coordination reduces severity and ultimately saves lives by leveraging the strengths of all partners, including existing pharmaceutical and vaccine management, distribution, and administration infrastructures. Improved coordination prior to and during a public health emergency also improves relationships, not only for public health emergencies, but also for routine public health delivery.
This MOU outlines the roles and responsibilities between MDH and Pharmacy in planning for and responding to public health emergencies requiring MCMs.
Included and incorporated into this MOU is "Appendix A: Readiness Guidance for Pandemic Influenza Vaccination in Pharmacy Settings" which provides details regarding pandemic vaccine provider enrollment, training and communication, as well as tracking pandemic vaccine allocation, distribution, and administration.
New pandemic influenza vaccination readiness guidance will be presented as it is updated. Additional guidance documents specific to other MCMs, such as antivirals or antibiotics, will be provided at the time of an incident.
II. General Responsibility of MDH and Pharmacy
This MOU establishes that, before a public health emergency is declared, both MDH and Pharmacy will jointly plan for dispensing and administering MCMs through Pharmacy.
The construction, validity, performance, and effect of this MOU will be governed by the laws of Minnesota. MDH and Pharmacy acknowledge this MOU is only a statement of intended mutual and voluntary cooperation and is not intended to be a legally binding contractual agreement.
Pharmacies interested in providing MCMs must also comply with all federal and state requirements, which includes signing a Pandemic Vaccine Provider Agreement Form, when available and if required by the Centers for Disease Control and Prevention (CDC).
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 to this MOU agrees to release, hold harmless, or indemnify the other party from liability that may arise from or relate to this MOU.
Section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), as enacted by the Public Readiness and Emergency Preparedness Act ("PREP Act") (Pub. L. No. 109-148), if enacted at the time of a public health emergency, may provide additional liability protections for actions carried out under this MOU. Additional information on the PREP Act, including the declarations issued by the Secretary of Health and Human Services (HHS) invoking the Act's protections, may be found at: http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
III. Definitions
- Authorized representative: Person or persons authorized by MDH to request, or Pharmacy to assist in distributing and administering, MCMs and to serve as chief point of contact for other communications, unless otherwise agreed upon.
- Influenza pandemic: Sustained human-to-human transmission of a novel influenza virus and infection across multiple countries and continents.
- Immunization information systems (IIS): Confidential, population-based, computerized databases that record all immunization doses administered by participating providers to persons residing within a given geopolitical area. Minnesota's IIS, managed by MDH, is called Minnesota Immunization Information Connection (MIIC).
- Medical countermeasures (MCMs): medicines (i.e. antibiotics, antivirals, antitoxins, etc.) that may be given in support of treatment or prophylaxis (oral or vaccination) to the identified population in accordance with public health guidelines and/or recommendations.
- Pandemic vaccine: Vaccine product, including both vaccine antigen and vaccine adjuvant, used to provide immune priming or direct protection from infection caused by a pandemic influenza virus.
- Vaccine constituent products: Syringes, needles, vials, shot cards, and all other ancillary supplies required for vaccine administration.
- Vaccine provider: Any provider designated by CDC or state and local immunization programs to receive and administer vaccine and constituent products from the CDC or its contracted distributor during the response. Vaccine providers may include pharmacies, which may have multiple provider locations.
IV. Participation
The Pharmacy has a desire to assist MDH in planning for, distributing, and administering MCMs to the general public during a public health emergency. MDH and Pharmacy agree that any and all actions taken pursuant to this MOU shall be voluntary and at each participant's sole discretion.
V. How to Invoke Assistance
MDH's authorized representative may request assistance of Pharmacy in distributing and administering MCMs by contacting Pharmacy's authorized representative. The provisions of this MOU only apply to requests for assistance made by and to such designee(s). Requests may be oral or written. If oral, the request shall be confirmed in writing as soon as possible.
VI. Term and Termination
This MOU shall become effective immediately upon its execution by Pharmacy and MDH. This MOU shall remain in effect between Pharmacy and MDH for five (5) years or until participation in this MOU is terminated by either MDH or Pharmacy pursuant to written notification delivered to the other no less than thirty (30) calendar days in advance of the termination date.
VII. MOU Review
This MOU and its appendices will be reviewed at least once annually by an advisory group made up of MDH and Pharmacy representatives, as convened by MDH.
This MOU and its implementation will be formally reviewed following its use during a public health emergency, and recommendations from an after action report will be incorporated to update and improve any operational plan.
VIII. Amendment
This MOU may be amended by written and signed mutual agreement of MDH and Pharmacy at any time.
IX. Authority to Sign
By signing this MOU, each party represents that it has the legal authority to enter into this MOU.