Annex 1, Appendix 5 STRATEGIC NATIONAL STOCKPILE COUNTERMEASURE DISTRIBUTION & DISPENSING STANDARD OPERATING PROCEDURES (SOP)

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1 Annex 1, Appendix 5 STRATEGIC NATIONAL STOCKPILE COUNTERMEASURE DISTRIBUTION & DISPENSING STANDARD OPERATING PROCEDURES (SOP) Under 42 USC 300hh-12(c), no federal agency shall disclose under section 552, United States Code, any information identifying the location at which SNS Program materials are stored. To the extent permitted by law, the parties agree that neither will disclose the nature of this effort and the terms of this agreement to any person or entity, except as may be necessary to fulfill its mission and statutory and regulatory responsibilities. PRIMARY: SUPPORT: Department of Health and Environmental Control (DHEC) Office of the Governor, Office of The Adjutant General, SC National Guard and Emergency Management Division; State Law Enforcement Division; State Department of Public Safety; Department of Transportation; Office of the Attorney General; State Budget and Control Board; State Department of Education; State Commission on Higher Education; Department of Labor, Licensing and Regulation, Division of Professional and Occupational Licensing and Division of Fire and Life Safety; Department of Defense; American Red Cross; SC Baptist Association; SC Hospital Association; SC Medical Association; SC Nursing Association; SC Pharmacy Association I. INTRODUCTION A. The Strategic National Stockpile (SNS) of the Centers for Disease Control and Prevention (CDC) is a federally owned and managed national repository of antibiotics, antiviral medication, chemical antidotes, antitoxins, life support pharmaceuticals and equipment, vaccines, intravenous administration supplies, airway maintenance supplies, masks, medical/surgical items, pandemic countermeasures and other medical related supplies established by Congress to supplement and re-supply state and local supplies of these critical need medical items in the event of an incident anywhere in the United States involving weapons of mass destruction,(chemical, biological, radiological or explosive) or a major natural or technological disaster. This plan provides for the request, receipt, staging, storage, repackaging, distribution, dispensing, and retrieval and return of any unused assets of this stockpile, pandemic countermeasures or other medical countermeasures depending upon the event. B. Purpose: This SOP implements S.C. Strategic National Stockpile Emergency Operations Plan Standard Operating Procedure which is incorporated into Annex 1, Appendix 5 Mass Casualty Plan of the South Carolina Emergency Operations Plans (EOP). This SOP provides operational guidance to those who are assigned to work in ESF-8 at the State Emergency Operations Center, the DHEC Emergency Operations Center, DHEC Health Region Emergency Operations Center and in all phases of SNS or other countermeasure distribution and dispensing operations. Rev Jan 2013 ANNEX 1-Appendix5-1-1

2 C. Authorities and References: 1. SC Emergency Operations Plan (SCEOP) 2. SC Emergency Operations Center (SEOC) Plan 3. SC DHEC Emergency Operations Plan 4. SCDHEC, Office of Public Health Preparedness, Emergency Notification Plan 5. SC Mass Casualty Response Plan, Appendix 5 of the SCEOP 6. Title V, Emergency Preparedness and Response, section 502 of the Homeland Security Act of SC Emergency Health Powers Act amendment to SC Homeland Security Act of 2002, rule R Implementation of the Emergency Health Powers Act 8. Receiving, Distributing, and Dispensing the Strategic National Stockpile, A Guide for Planners, Version 10.02, August PB1 ( ) Public Health Emergency Preparedness Cooperative Agreement D. Organization: The DHEC Director of Emergency Management, Office of Public Health Preparedness, assisted by the DHEC Emergency Management Coordinator and other support staff will serve as the lead of ESF-8 response and recovery efforts, which includes all state and region Strategic National Stockpile, or other countermeasure distribution and dispensing activities, and upon activation will be located at the State Emergency Operations Center (SEOC), 1100 Hatchery Road, West Columbia, SC All SNS response staff that has leadership roles is NIMS compliant in accordance with DHEC policy A.1101, the Homeland Security Presidential Directive (HSPD)-5 and the State of South Carolina Office of the Governor Executive Order Number signed 27 January These ESF-8 representatives will coordinate Strategic National Stockpile efforts through each DHEC Regional Health Director and/or the Regional Director of Public Health Preparedness or their designee. In support of ESF-8, the Office of Public Health Preparedness will coordinate among DHEC deputyships, program areas, named support agencies and participating private sector resources to support SNS preparedness plans and response in accordance with this SOP and in conjunction with the South Carolina Emergency Management Division and the South Carolina Emergency Operations plan. At the determination of the DHEC Director, the DHEC Emergency Operations Center (DHEC EOC) may be activated to help coordinate other department responsibilities associated with a SNS countermeasure deployment to South Carolina. Rev Jan 2013 ANNEX 1_Appendix 5-1-2

3 The SEOC ESF-8 representative will coordinate and monitor SNS response and recovery efforts through the DHEC EOC. This information will be monitored and executed through WEBEOC at the South Carolina Emergency Operations Center. These SNS activities will be monitored by the DHEC EOC and further managed using the DHEC copy of WEBEOC. SNS response information will be provided to ESF-5 (Information & Planning) by ESF-8 as needed for the standard SEOC Situation Reports. All public information related to the event will be released in coordination with the joint information center (JIC) located at the SEOC. E. Plan Hierarchy: The SNS Emergency Operations Plan is written to be functional as incorporated as Annex 1, into Appendix 5 South Carolina Mass Casualty Emergency Operations Plan of the South Carolina Emergency Operations Plan. DHEC Health Regions and the Columbia Metropolitan Statistical Areas (MSA) Cities Readiness Initiative (CRI) are also required to have an SNS plans to function as extensions of the State SNS plan and in coordination with the Regional Mass Casualty plans. Operations in this plan are to be coordinated by ESF-8 and the ESF-8 SOP. II. MISSION The mission of the Strategic National Stockpile is to rapidly and safely provide antibiotics, antiviral medication, chemical antidotes, antitoxins, life support pharmaceuticals, vaccines, intravenous administration supplies, airway maintenance supplies, masks, pandemic countermeasures and medical/surgical items in a rapid and safe manner to supplement and re-supply any community in South Carolina in the event that state and local capacities are exceeded or are about to be exceeded due to a weapon of mass destruction or a major natural or technological disaster. This plan s mission is one of response in support of the ESF-8 mission of health and medical and as such serves as the plan for all medical material acquisition and distribution. III. SITUATION AND ASSUMPTION A. Situation: 1. A mass casualty event has occurred or is imminent in South Carolina involving a weapon of mass destruction or a major natural or technological disaster has occurred. 2. The capacity of South Carolina s local and state assets to meet the demand for pharmaceuticals, vaccines, medical supplies, or other related countermeasures or medical equipment is inadequate or has been exceeded. B. Assumptions: Rev Jan 2013 ANNEX 1_Appendix 5-1-3

4 1. The State Emergency Operations Plan will be activated. 2. The State Emergency Operations Center will be activated at Operating Condition 1 (OPCON 1) or the appropriate Operating Condition as well as responding county EOC s. 3. The South Carolina Emergency Management Division will activate the Statewide Mutual Aid Agreement and the Emergency Management Assistance Compact. 4. All infrastructures including communications are intact. 5. The appropriate state and federal declarations have been made by the Governor of South Carolina, the President of the Unites States and the Secretary of the Department of Human Services. 6. The arrival of the Strategic National Stockpile 12-Hour Push Package from the federal stockpile to the state receiving, staging and storage site (RSS) warehouse will occur within 12 hours and the managed inventory palletized material will occur within 24 hours once the CDC decision to deploy has been made per DSNS guidance. Delivery to the Health Regions will not occur until 12 hours after the first receipt of federal medical materials. 7. South Carolina has a centralized public health system under the South Carolina Department of Health and Environmental Control (DHEC). All county health departments are staffed and managed by DHEC and respond to emergencies as one agency. Planning and daily management are done utilizing the 8 DHEC Health Regions as the administrative unit. Each of these Regions geographically contains four to ten counties and has in round numbers between 250,000 to 1,000,000 residents. IV. CONCEPT OF OPERATIONS A. South Carolina Department of Health and Environmental Control, lead agency for ESF-8, is responsible for developing, coordinating and maintaining procedures to support the SNS plan as contained in Appendix 5 South Carolina Mass Casualty Emergency Operations Plan of the SC Emergency Operations Plan in conjunction with SC Emergency Management Division. DHEC is responsible for the coordination of all SNS administrative, management, planning, training, preparedness/mitigation, response, and recovery activities to include developing, coordinating, and maintaining the. All ESF-8 supporting agencies will assist DHEC in the planning Rev Jan 2013 ANNEX 1_Appendix 5-1-4

5 and execution of the above as specified in the SCEOP by Gubernatorial Executive order signed January 27, B. Coordination with all supporting and other appropriate departments/agencies and organizations will be performed to ensure operational readiness in time of emergency. C. DHEC shall provide an Emergency Management Coordinator or Alternate, designated by the Director, to represent ESF-8 and the SNS at the SEOC, who, on the behalf of, or in the Director's absence from the SEOC, shall act to meet the health and medical responsibilities as described in the SCEOP. This person will be the point of contact and SNS lead for ESF-8 and SNS Operations at the SEOC. Additional public health personnel to coordinate the state level response will be housed at the DHEC Emergency Operations Center located on the second floor of the Sims/Aycock building, 2600 Bull Street, Columbia, SC D. In coordination with the Office of Public Health Preparedness and the SNS Pharmacist, the DHEC Public Health Regions assess the situation (both preand post-event), and in coordination with local county emergency management officials and response agencies, develop strategies to respond to the emergency. E. Requesting the SNS: The decision to deploy the SNS will be a collaborative effort between local, state, and federal officials. After the recognition of a potential or actual WMD event or a major natural or technological disaster that may or will exceed local medical capacity, the Region Health Director will contact the Office of Public Health Preparedness Director of Emergency Management. The initial recognition of this event may occur at the state level by DHEC and as such the notifications will be made at that point. A strategic policy group comprised of the Governor, the SC EMD Director, and the DHEC Director will be convened to determine if the SNS should be requested. If the Federal assets are required, the DHEC Director on behalf of the governor will request the deployment of the SNS in SC in one of two manners. 1) In federally declared disasters it will be necessary to prepare the Action Request Form (FEMA form ) and process this form through the SC Emergency Management Division request process for federal assistance through DHS/FEMA. Upon submission of the request form and approval, DHS/FEMA will direct HHS to provide the appropriate assistance. 2) In the absence of a federally declared disaster the DHEC Director will initiate the process in one of 4 ways. Contact the HHS regional emergency coordinator (REC). Rev Jan 2013 ANNEX 1_Appendix 5-1-5

6 Reach out to the SNS program services consultant (PSC). Call the CDC emergency operations center (EOC) at Call the HHS secretary s operations center (SOC) at Once a request is received, federal agencies will collaborate with the state officials to evaluate the nature and magnitude of the public health threat and to understand how the use of federal medical supplies will address the public health threat. If a catastrophic incident occurs, credible threats exist or an attack is imminent, the federal government may direct deployment of SNS material before a public health emergency declaration; a federal Stafford Act disaster declaration or receipt of requests for DSNS assets. The US Marshall s service no longer routinely deploys with the SSAG. South Carolina may receive the 12-Hour push package or may receive palletized material (4 X 4 X 4 pallet) from managed inventory or a combination of the two. How the SNS material is deployed and signed for will be coordinated as part of the request for assistance between the state and DSNS. The SNS Services Advance Group (SSAG) who will determine the type of technical assistance required in response to the State s request. Technical assistance requirements, including specific objectives and timeframes, will be coordinated as part of the request for assistance from the project area. This request will be made by calling the CDC Director s Emergency Operations Center (DEOC) F. In response to the event, the Secretary of HHS has properly issued a public health emergency declaration, justifying the emergency use of certain medical counter measures to diagnose, treat, provide prophylaxis or prevent the identified threat. The FDA Commissioner has properly issued an emergency use authorization for the medical countermeasures shipped to South Carolina, and DHEC has received and made sufficient copies of the fact sheets required by the FDA to be distributed or dispensed with the medical countermeasure. The DHEC Director will request that the Governor declare a state of emergency and a public health emergency allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. G. Prior to the arrival of the Federal assets or in the event that Federal assets are not yet available, the SNS pharmacist or designee will transfer the State of South Carolina owned drugs from the pharmaceutical cache located at the PHP Pharmacy, 8229 Parklane Road, Columbia, SC to the Rev Jan 2013 ANNEX 1_Appendix 5-1-6

7 predetermined RSS site for distribution per this plan. If the magnitude of the event does not warrant utilization of the predetermined RSS site, distribution operations will be run out of the PHP pharmacy which has been surveyed by the DSNS program consultant and the US Marshall s service. H. Receipt: Once the deployment of SNS assets have been ordered the State Emergency Operations Center will be activated at OPCON 1 or the appropriate Operating Condition and the Governor will declare a state of emergency and a public health emergency allowing for the implementation of the South Carolina Emergency Health Powers Act and its associated regulations. The responding county EOC s will also be activated at the appropriate Operating Condition. A draft South Carolina Emergency Health Powers declaration has been written by the DHEC Office of General Counsel and is available in the event it is needed. DHEC will request the following resources to support this plan through the State Emergency Operations Center (SEOC): warehouse, warehouse management and inventory tracking, on-site security, transportation and security during transport, communication, law enforcement and traffic control. These resources will be provided by the support agencies as specified in the SCEOP. The DHEC Director has predetermined an SNS Receiving, Staging and Storage (RSS) site for the receipt of all DSNS materials which include pandemic influenza and other countermeasures. This primary RSS location has been validated by the DSNS program services consultant and the US Marshall s service. The SC SNS Pharmacist or designee will notify the Receiving, Staging, and Storage site of the deployment of the SNS assets by the DSNS. Previously when the SNS 12- Hour Push-Package or Managed Inventory arrived at the SNS RSS site the CDC liaison for the SNS will immediately transfer custody of the SNS assets to the State of South Carolina using the CDC Strategic National Stockpile Program Medical Material Transfer Form and the DEA Form 222. As of 10/6/2009 How SNS materiel is deployed and signed for will be based on numerous factors and will be coordinated as part of the request for assistance between the project area and DSNS. The SC SNS Pharmacist or designee is designated by the DHEC Director to officially accept the custody of the SNS assets from the CDC for the State of South Carolina at the SNS RSS site. In addition to the SNS Pharmacist the following pharmacists may sign for the SNS, the Director of Pharmacy DHEC Health Services, the Director of the DHEC Bureau of Drug Control, the back-up SNS Director or the Assistant Director DHEC Bureau of Drug Control. The Region Distribution sites will be notified of the arrival of the SNS assets at the RSS site. South Carolina may accept all or part of the 12-Hour Push-Package. Rev Jan 2013 ANNEX 1_Appendix 5-1-7

8 In the absence of an emergency declaration by the Governor of South Carolina operations will be managed at the Public Health Preparedness Pharmacy Warehouse. This facility is licensed by the S.C. Board of Pharmacy and S.C Drug Control and the federal Drug Enforcement Agency (DEA). Vaccines shipped to the RSS site or PHP Pharmacy will be stored in the Division of Immunization walk-in refrigerator (8 feet X 12 feet) at the DHEC Hayne Building SC Board of Pharmacy, non-dispensing drug outlet permit # 10385, 8231 Parklane Road if the quantity shipped exceeds the capacity of the PHP Pharmacy refrigerator. All vaccine storage and handling will follow the DHEC Division of Immunization Vaccine Storage and Handling policy rev. 02/09/12.Once the determination has been made as to where the vaccines need to be delivered, the vaccines will be transferred to the DHEC Health Region locations with vaccine refrigerators by ESF-2 or by the DHEC Bureau of Business Management depending upon the size of the event. I. Staging: Once custody of the SNS assets have been signed for by the Director of the Strategic National Stockpile and transferred to the State of South Carolina at the RSS site or PHP pharmacy, these assets will be off loaded and staged. The SNS shipping containers will be arranged in a color-coded schematic by product type and container number: Red: Oral Antibiotics Yellow: Intravenous Drugs and Supplies Blue: Airway Management Green: Chemical Antidotes and Supplies White: Medical/Surgical Supplies Pink: Pediatric Drugs and Supplies Refrigerated items and control substances will be shipped in specialized containers to maintain proper storage and legal requirements. Noncontainerized materials will be arranged in an area separate but adjacent to the containerized materials. Like items will be grouped together. J. Distribution: While the SNS assets are being staged at the RSS site, the DHEC Region Director or designee in conjunction with local emergency management officials will request the supplies that are needed to replenish exhausted local inventories thru the DHEC Region s incident command structure in conjunction with the affected counties incident command structure. The intravenous medicines, IV administration supplies, fluids, life support medicines, airway equipment, antidotes and symptomatic treatment material for casualties; and medical or surgical items for treating casualties from a WMD or a major national natural event will be transported from the RSS site to the Region Distribution site for transfer to the designated hospitals or directly to the designated hospitals as specified in the DHEC Health Region SNS plan. Transportation assets to perform this will be requested through ESF-2 at the South Carolina Emergency Operations Center (SEOC). Rev Jan 2013 ANNEX 1_Appendix 5-1-8

9 All Control Drugs will be transferred to the designated treatment center s Drug Enforcement Agency (DEA) registrant employing DEA form 222 where applicable. All Control substances will be packaged separately from other legend drugs and will be transferred utilizing the Control Substances in 12- Hour Push Pack form revised 9/2011. All Control substances not transferred to designated treatment center s DEA registrant will be transferred to the PHP pharmacy which is a SC Drug Control/DEA as well as SC Board of Pharmacy permitted location. Post exposure prophylaxis packages, initial 10 day supply, will be delivered to the Region Distribution sites. The numbers of regimens needed has been determined based upon the total population of the Health Region. Additional supplies of post exposure prophylaxis will be shipped upon request to the affected Region. Follow on 50 day prophylaxis and/or Anthrax Vaccine Adsorbed as required by an anthrax exposure will be delivered to the Health Region once received from the DSNS. The 50 day follow on supplies for the completion of prophylaxis and/or vaccine will be dispensed/administered by the Regions to those individuals who were truly exposed as determined by epidemiological investigation. The Region Distribution site will distribute these initial regimens to the identified first responder site, any facility with a confined population with pharmaceutical services for treatment of residents, staff and staff s family, the closed large employer points of dispensing and to the mass public points of dispensing for distribution to the general public. Hospitals will request any needed SNS medical material other than initial prophylaxis supplies from the State RSS site through the ESF-8 liaison at their county Emergency Operations Center or through the Region unified medical command. These requests will be forwarded to the RSS site by the ESF-8 leads at the State Emergency Operations Center. The Region Distribution sites will meet the same specifications as the RSS site. A memorandum of agreement currently is in place with the Department of Labor, Licensing and Regulation, Board of Pharmacy to insure temporary licensing of drug distribution and dispensing locations. These distribution sites are located in each DHEC Health Region and can serve as an alternate RSS site in a more localized event. The DHEC Health Region plan will provide for necessary support to off load the shipment, manage and track the inventory, and on-site security at the Region Distribution site. Transport and transport security, and traffic control of the medical supplies from the Region Distribution site to the predetermined receiving hospital or to the predetermined dispensing site will be specified in the Region SNS/CRI plan. The Region SNS/CRI plan will specify an individual from the predetermined treatment center/hospital to be available to accept custody of the SNS control drugs from the DHEC Drug Control Pharmacists. Unless stated otherwise the Rev Jan 2013 ANNEX 1_Appendix 5-1-9

10 control substances will be delivered to the main pharmacy within the hospital and received by the Director of Pharmacy or his designee. The DHEC Region Director (or designee) will be the lead official at the Region Distribution site and will specify an individual to accept custody of the shipment of the SNS assets from the RSS site and will assure that the Region Distribution Site is made ready to receive countermeasures from the RSS site. The SNS Operations lead or designee will notify the Region Distribution Site of the deployment of the SNS from the RSS site to the Region Distribution site. The Region SNS and CRI plans will arrange for transportation and security of post exposure prophylaxis packages to the local points of dispensing for dispensing to the entire Region population within the prescribed time frame. K. Continuation of Supplies: While the initial CDC 12-Hour Push Package and/or other pharmaceuticals are being distributed from the RSS site to the Region Distribution Site, the DHEC Region Director in conjunction with local/county emergency management officials will continually assess the need for additional supplies of specific items. If additional medical materiel is needed, the SC SNS Pharmacist or designee at the RSS site will request these items from the CDC by calling the CDC 24 Hour Hotline, or the CDC Switchboard, If the event is a declared national disaster and the National Response Framework has been activated the Department of Homeland Security would establish a Joint Operations Center (JOC) with an Emergency Support Function # 8 (ESF-8) for health and medical services. ESF-8 at the SEOC would request federal support through the tasking desk at the SEOC to ESF-8 at the JOC. A FEMA Action Request Form (ARF) for the additional assets may be required. The same process will be followed as in the initial request phase of the response. The Managed Inventory pharmaceuticals may arrive in bulk or repackaged regimens and will be shipped directly to the RSS site from their points of origin. Additional pharmaceuticals and/or medical supplies not available through the Strategic National Stockpile Managed Inventory program may be procured through the State of South Carolina emergency procurement procedures. These procedures may utilize national resources such as RX Response. In an event when the causative factors have been identified and the DHEC Region Health Director in conjunction with local/county emergency management officials and the CDC Director can determine the specific supplies that are needed, the first shipment received may be from the Managed Inventory and not from the multi-hazard 12-Hour Push Package. The Region Distribution Sites will report continually to the RSS site the number and type of prophylactic regimens dispensed, the number and types of SNS assets transferred to the treatment centers and the projected number of additional assets that will be needed. Requests for additional assets for the Rev Jan 2013 ANNEX 1_Appendix

11 RDS site from the RSS site will be received at a minimum of daily in conjunction with the reports. The frequency of these reports will be determined by the specific incident. The points of dispensing will request additional post exposure prophylaxis antibiotics from the Region Distribution Site. The process for this request procedure will be specified in the Region SNS plan and will mirror the RDS to RSS request process. Inventory Control at the RSS site and the Region Distribution site will follow the procedures below. The DHEC Bureau of Finance will be the lead for inventory control at the RSS site. The Region/ CRI plan will identify the inventory lead at the Region Distribution site. The initial packing slips will be given to the inventory clerks for entry into the manual inventory system. All items received and distributed will be listed one product per page on DHEC form 1285 SNS Perpetual Inventory. The following information will be recorded per item: (1) Item description found on the inventory list provided by DSNS (2) Lot Number and expiration date (3) NDC number found on the inventory list provided by DSNS (4) Unit of measure found on the inventory list provided by DSNS (5) Unit pack (number per case or box) found on the inventory list provided by DSNS All items will be recorded as each and distributed by box or case. There will be a running decreasing balance (similar to a checkbook) inventory sheet for every item contained in the shipment. Each entry into the checkbook will list the following: (1) Which container the item came from or (2) Where the item is going to (3) Number received or shipped Currently the inventory tracking system for the state level response is transitioning to the secure federal Inventory Management and Tracking System (IMATS). This system will track all SNS assets which can be preloaded by the DSNS. The Region Distribution site will continue to use the paper system or an excel spreadsheet since the RDS in most instances will handle only oral medications or vaccines. The initial shipment of SNS materials will be apportioned and shipped to the affected Region Distribution site, treatment facilities or point of dispensing based on population if the threat has been identified. DHEC form 1286 or 1287 will be used to record the following information concerning the shipment: (1) Region or Point of Dispensing (2) Treatment center (if applicable) (3) Date (4) Time Rev Jan 2013 ANNEX 1_Appendix

12 (5) Lot Number & Expiration date (6) NDC Number (7) Quantity (8) Requested by (if applicable) (9) Filled by (10)Time Filled (11)Delivered by (12) Time delivery left All Control substances will be packaged separately from other legend drugs and will be transferred utilizing the Control Substances in 12-Hour Push Pack form revised 9/2011. This form will be completed by the individual who signs for the control substances and will be given directly to the DHEC Drug Control pharmacist who will make the delivery to the hospital on the delivery slip. All drugs control, legend, or other countermeasure will be tracked in the same manner. The original slip will go to the perpetual inventory clerk and a copy will be given to the fulfillment area to be filled. Once the order is filled and all names are recorded two copies of the filled order form will then go with the shipment as the packing slip and delivery slip. The packing slip will be inside the order and the delivery slip will be signed and returned to the inventory clerk at the RSS site or Region Distribution site. This slip may be returned via the truck driver in hard copy or by fax. The original will return to the inventory clerk to match the filled order with the requested order. The contents of the shipment will then be subtracted from the perpetual inventory. These processed orders will then be set aside awaiting verification of receipt of the order from the Health Region. The fulfillment area will be manned by 4 teams of 4 people each. The DHEC forms 1285, 1286, and 1287, 1288 can be found on the DHEC intranet site and can be accessed as follows: --Technologies Tab RIMS PDF Forms Control Substances in 12-Hour Push Pack form revised 9/2011 will be provided at the time it is required by the SNS Pharmacist or designee. Once the agency EOC is activated and WebEOC is being used to track the incidence all forms related to the response will be posted in WebEOC. L. Dispensing Sites: The Region Health Director or his designee in conjunction with local/ county emergency management agencies will develop the Health Region Strategic National Stockpile and City of Columbia Metropolitan Statistical Area (MSA) Cities Readiness Initiative (CRI) plans which identify adequate public/ private points of dispensing to provide initial ten day prophylaxis for the entire population within 48 hours of the federal decision to ship medical countermeasures into South Carolina in response to a disease Rev Jan 2013 ANNEX 1_Appendix

13 outbreak or other emergency event. First responder dispensing sites separate from the public points of dispensing will be identified in each Region plan. If the emergency event is a disease outbreak and laboratory confirmation of the infecting organism has been made additional prophylaxis up to 60 days may be required for those exposed to the infecting agent. The DHEC Region Health Director (or designee) will insure that symptomatic individuals are directed to treatment facilities, guidelines are followed to determine whether an individual needs prophylactic drugs, individuals are counseled on the threat/risk of the drug, potential contraindications in individuals are identified, guidelines for correct dosage based on age and weight are provided, proper documentation is maintained identifying individual that is receiving the drug, lot number, NDC number, expiration date, and amount of drug received, and that the people who receive a drug understand how the drug is to be taken and how and who report adverse reactions to the countermeasure. In the event that the drug is being dispensed to the public on a Food & Drug Administration Emergency Use Authorization ( EUA), the DHEC Region Health Director will ensure that all terms of the EUA are followed prior to dispensing including providing adequate dispensing information as provided by the manufacturer or the DSNS to all public and private points of dispensing. Adults may pick up as many medication regimens as needed for children and homebound adults, with government issued identification, if they can provide age, weight and a brief medical/ prescription drug history of the person for whom they are picking up medication. No identification is required for adults, anyone age 16 or over, picking up medication for themselves only. Unaccompanied minors, anyone under 16 years of age as defined by section SC Code of Laws who arrive at a Dispensing Site will be escorted to the special needs area by the behavioral health team where every effort will be made to contact the parent or guardian prior to dispensing any countermeasure. If a parent or guardian cannot be located the child will be placed with the SC Department of Social Services Child Protective Services after the proper dosage of medication is dispensed under the authority of SC Code of laws section Provisions must be specified in the Region SNS plan to accommodate citizens with a variety of special needs such as language, vision and mobility barriers at the dispensing sites. The DHEC Region Health Director (or designee) will be the lead official at the public points of dispensing. Large employers, that meet the requirements to serve as a point of dispensing for their employees and employee s family will identify the lead official at the employer s closed dispensing site and that person will be listed in the Region SNS or CRI plan. Facilities with confined populations and established medication dispensing procedures will provide to the Region distribution site the number of needed Rev Jan 2013 ANNEX 1_Appendix

14 regimens and will follow their usual and customary medication dispensing procedures for patients/ residents, staff and staff s family following CDC and DHEC guidelines and recommendations. Examples of these affected institutional populations are hospitals, nursing homes, military installations or prisons. These medications may be either unit of dispensing containers or bulk containers. These institutions and how they will receive their medication will be identified and defined in the DHEC Region or CRI. The DHEC Region SNS and CRI plans will also identify large employer closed points of dispensing. These facilities may not have pharmacy permits but will follow the scope of services as set forth in the DHEC 870(Volunteer Health Care Provider Agreement). The DHEC Region/CRI plans will identify how traffic control and security will be provided at the large employer closed point of dispensing. Each mass public/closed dispensing site will need to provide for the following characteristics, while allowing differences to accommodate the various facilities hosting the dispensing site and the security requirements of local law enforcement. Adequate signage needs to be in place to ensure a smooth patient flow. (1) One way into the parking lot of the facility and one way out (2) One way into the building and one way out. Be sure that those arriving do not have access to stop and visit with those that are leaving. (3) An area to screen for those that are currently symptomatic awaiting transfer to treatment facility (4) An area to fill out necessary paperwork and receive disease and drug information via video or printed material. (5) An area for medical/pharmaceutical counseling if needed. (6) A drug and patient drug information sheet dispensing area (7) A special needs area (8) A holding area for patients creating a disturbance. Depending upon the nature of the disturbance this room can be used for counseling by social work or law enforcement. (9) An area to stamp the hand of the person receiving the medication to prevent them from immediately returning to the line. (10) A secure area to store the pharmaceuticals and a delivery access point and route away from public view. M. A memorandum of agreement currently is in place with the Department of Labor, Licensing and Regulation, Board of Pharmacy to insure temporary licensing of mass public and large employer closed drug dispensing sites and distribution sites in a Gubernatorial declared emergency. This waiver is for the duration of the declaration or 30 days whichever is less. After 30 days a new declaration will be required. The following procedures have been established to ensure safe drug dispensing and adequate record keeping to protect the public health, safety and welfare in a mass casualty event that Rev Jan 2013 ANNEX 1_Appendix

15 would require federal or other medical countermeasures being sent to South Carolina. All necessary forms including the standing orders will be posted to WEBEOC under file library once most current CDC event driven updates are available. 1. Protocols/ standing orders to provide current guidelines for the assessment, prophylaxis and/or treatment and follow-up of persons who may be exposed to a biological and/or chemical agent. These protocols can be found in the DHEC standing orders manual that is available on the DHEC intranet site. To access these orders go to dhecnet program areas-health services manuals & reports- Health services standing orders manual BT tab. Copies of these orders will be printed by the Region Health director or his designee and be available for review at the points of dispensing. Healthcare workers and others who participate in the response effort will use these protocols to insure uniform treatments for all citizens of South Carolina. These protocols include the CDC treatment and post exposure prophylaxis guidelines. 2. The Clinical Evaluation Form for Dispensing Mass Post- Exposure Prophylaxis Therapy ( DHEC 1288) form for patients exposed to a biologic agent will serve as the (1) exposure screening form, (2) dispensing record, (3) refill record, (4) medical chart and (5) acknowledgement of receiving treatment. To access this form go to dhecnet program areas- technologies RIMS PDF forms. This form will be filled out for every person who receives prophylaxis. This record is to be maintained in the Health Region pharmacy in lieu of a written prescription document for 3 years after the last date of service. After 3 years the record is to be transferred to archives where it will be maintained in accordance with DHEC policy A.932. The NAPH form will serve as the prescription form for any refills should they be necessary. A copy may be maintained in the county Health Department where services were rendered to insure rapid availability to the affected individual s private physician. Rev Jan 2013 ANNEX 1_Appendix Each prepackaged 10-day regimen from the CDC comes labeled with two perforated labels identifying drug, quantity, expiration date, NDC number and prescription number. One label will be attached to the NAPH form for the initial dispensing and for any refills that may be needed. The prescription number, quantity of drug, patient name, date and prescribing physician, (the Deputy Director of Health Services), will be handwritten on the dispensing label. To

16 comply with proper prescription labeling each Health Region must include the name of the Health Region, the complete address and the phone number on each of the dispensing labels printed at the Region. Each prescription must be labeled as to proper dosing instruction and each prescription will be labeled with the following statement: Call your doctor for medical advice about side effects. You may report side effects to Food & Drug Administration at FDA Rev Jan 2013 ANNEX 1_Appendix Each patient will be counseled on the proper use of the drug and any drug- drug and drug- medical condition interactions using the Patient Counseling Information for Selected Antimicrobials Used for Prophylaxis Following Exposure to Potential Bioterrorist Agents. A Notification to the Patient s Primary Care Physician Form DHEC form 1289 will be given to the patient to take to his/her physician. General patient drug information is available to DHEC through internet based drug information at The log-in is located on the left side of the page. Click on e answers log-in and on the left side of the page is medfacts patient information. Click on that and scroll through until you find the drug. Each Region with a pharmacy should have an IP address set up with access to this site. If not login with SCDOHAEC and SCDOHAEC1. Each drug information sheet will be labeled with the following statement: Call your doctor for medical advice about side effects. You may report side effects to Food & Drug Administration at FDA Any countermeasures dispensed under an Emergency Use Authorization will be dispensed with the patient information prepared by the requesting authority of the EUA. Each dispensing site will also have available information on the causative agent if known for distribution to the general public. This information will be prepared at the time of the incident initially using the Centers for Disease Control and Prevention (CDC) agent information sheets available at until the most current information can be incorporated into the SCDHEC agent information. Countermeasures that have not completed the Food and Drug Administration approval process may be dispensed as an investigational new drug (IND) or on an Emergency Use

17 Authorization (EUA). The CDC designated lead center, institute or office will obtain approval from the FDA to use specific IND protocols for medical countermeasures. The CDC will provide the forms that patients must read and sign to give informed consent at the time of the event. CDC will provide the latest versions of the protocols, authorizations and instructions for use to be distributed with the countermeasure. In the event that countermeasures are required that have not completed the FDA approval process and are not being dispensed as an IND, DHEC will ensure that a FDA Emergency Use Authorization has been obtained by the manufacturer or requesting authority and all appropriate paperwork will be distributed with the countermeasure to the DHEC Public Health Region Distribution site for distributing with the antiviral or other countermeasure to the healthcare provider or public or closed point of dispensing. These healthcare providers or public or closed points of dispensing will be informed of the conditions under which the countermeasures can be dispensed as are set forth by the FDA Commissioner at the time that the Emergency Use Authorization is granted such as: (1) distribute FDA approved information for healthcare providers or authorized dispenser (2) distribute FDA approved information for recipients (3) monitoring and reporting adverse events (4) records maintenance The DHEC Region 3 and City of Columbia Cities Readiness Initiative (CRI) plans will coordinate planning with the Charlotte/Mecklenburg county North Carolina CRI to insure adequate coverage of York County South Carolina and the Catawba Indian Nation whose population is included under the Charlotte, NC metropolitan statistical area and is funded as part of the Charlotte CRI by the Centers for Disease Control and Prevention. The Office of Tribal government will have its members receive prophylactic medication through this process in a declared emergency. The ultimate responsibility for York County South Carolina falls under the DHEC Region 3 plan. N. Retrieval Per the terms of the 2010 memorandum of agreement between the Centers for Disease Control and Prevention (CDC) and the South Carolina Department of Health and Environmental Control (DHEC), the CDC retains title to the DSNS and Federal Medical Rev Jan 2013 ANNEX 1_Appendix

18 Station durable assets. Any durable assets sent to the Region Distribution Sites (RDS) will be returned to the Receiving Staging and Storage (RSS) site utilizing a transportation tasking to ESF-1 at the State Emergency Operations Center (SEOC). The RSS site will arrange for the pick-up of the durable assets from the RDS and returning it to the RSS. Upon CDC request and at CDC expense the durable assets will be returned to the CDC or when no longer needed for public health emergency response purposes. Also, per the terms of the 2010 memorandum of agreement between the CDC and DHEC, at the conclusion of a public health emergency response, CDC will assess the return of unused medical materiel to determine if sealed, non-pharmaceutical items stored in accordance with manufacturer recommendations can be returned to federal custody. CDC will not otherwise accept return of any unused medical materiel. Other unused medical materiel including pharmaceutical items will be returned to the RDS. Once all materiel is returned to the RDS site, these materiels will be returned to the RSS, with any durable assets, for final disposition. O. Communication: The communications function ensures the timely flow of information used in the decision making process as well as in operational effectiveness. The communications function involves 3 distinct areas. 1. Public Healthcare Communication All official public healthcare information related to the incident will be coordinated through and released in conjunction with the SC Emergency Management Division and participating agencies through the Joint Information Center (JIC) located at the State Emergency Operations Center as described in Annex 15 (ESF-15) of the South Carolina Emergency Operations Plan and in accordance with the DHEC Public Information Emergency Operations Plan. DHEC is the lead agency for all ESF-8, health and medical, response which includes primary responsibility for all messaging which affects the public s health. The types of information released will include information on the event itself, how to protect yourself and your family and any public health orders such as quarantine, shelter in place or evacuation orders. Also included will be messages how to get the medicine, cost of the medicine, medicine for pets, medication safety. SNS specific messages will include but not limited to where to pick up your medication, how to pick up your medication, why you need to pick up the medicine for you and your family, why you need to take the medicine, what medical information is needed to receive medication, what is needed for identification, how to take your medication, who should take the medication, how long to take the medication, what are the expected side effects of the medication, who to call in the event of unexpected side effects and what to do if your are currently symptomatic. Templates for these messages have been written and when needed will be incident specific and Rev Jan 2013 ANNEX 1_Appendix

19 distributed through local public information channels such as television, radio, newspaper and at the local dispensing sites by the healthcare professionals. Direct contact with affected individuals will be available through the call-in SC Public Information Phone System (PIPS), South Carolina 211 or the GIS based call-out system REACH SC. DHEC, ESF-8, will provide the prescripted messages to the community in a variety of ways to ensure that harder to reach populations due to economic disadvantage, language or literacy, medical issues, isolation or age will receive the necessary information. Since South Carolina has a centralized health agency, all DHEC Health Regions and the county health departments within those Regions will use the same public health information provided by DHEC Division of Media Relations. 2. Logistical/ Tactical Communication Types of information to be included but not limited to are as follows: expected number of potential individuals needing treatment, number treated with prophylactic medication and sent home, number transferred to hospitals or other treatment centers, number still requiring treatment, medications and supplies transferred to treatment center, additional SNS assets needed by treatment centers. These numbers will be reported on a regular basis as determined by the incident by the Region Distribution site lead to the RSS site and to ESF-8 at the State Emergency Operations Center. The DHEC EOC will monitor all response and recovery activities through the state and agency copies of WebEOC. The DHEC EOC will maintain communications with ESF-8, RSS Site, Region Distribution sites by , fax, telephone, cell phone, 800 MHZ radio. Requests from the county emergency operations center for SNS distributed medical countermeasures or other health and medical services will be either called into the SEOC by telephone, transmitted via WebEOC or by radio. The State Emergency Operations Center (SEOC) Operations Tasking Group (OTG) will task any such requests for health and medical services to ESF-8. DHEC representatives in ESF-8 will task either a support agency or the appropriate DHEC program area. This procedure is consistent with the request procedure found in the ESF-8 SOP. Requests from DHEC Health Regions to the DHEC EOC will be tasked by DHEC EOC personnel to the appropriate program areas within DHEC. Requests for support from outside the agency for Health Region response will be requested by the DHEC EOC thru ESF-8 or directly by the Health Region through the OTG at the SEOC. Completion of all tasks will be reported to the DHEC representatives in ESF-8 at the SEOC for inclusion in the periodic situation reports. This procedure is consistent with the request procedures found in the ESF-8 SOP. 3. Equipment Rev Jan 2013 ANNEX 1_Appendix