Microsoft word - tcl september 2007 - 09 30 07.doc

MASS PROPHYLAXIS
Capability Definition
Mass Prophylaxis is the capability to protect the health of the population through the administration of critical interventions in response to a public health emergency in order to prevent the development of disease among those who are exposed or are potentially exposed to public health threats. This capability includes the provision of appropriate follow-up and monitoring of adverse events, as well as risk communication messages to address the concerns of the public. Outcome
Appropriate drug prophylaxis and vaccination strategies are implemented in a timely manner upon the RESPOND MISSION: MASS PROPHYLAXIS
onset of an event to prevent the development of disease in exposed individuals. Public information strategies include recommendations on specific actions individuals can take to protect their family, friends, and themselves. Relationship to National Response Plan Emergency Support Function
(ESF)/Annex
This capability supports the Emergency Support Function: (ESF) #8: Public Health and Medical Services Preparedness Tasks and Measures/Metrics
Activity: Develop and Maintain Plans, Procedures, Programs, and Systems
Critical Tasks
Create plans and systems for mass prophylaxis patient movement and tracking Create plans and systems for the transport and tracking of medical supplies and equipment Develop procedures for obtaining mass prophylaxis supplies from the receipt, staging, and storage (RSS) sites in coordination with the Medical Supplies and Distribution Capability Develop plans, procedures, and protocols for mass prophylaxis dispensing operations Develop the tactical communications portion of the mass prophylaxis dispensing plan Develop a mass prophylaxis inventory management system Develop procedures for the distribution and dispensing of mass prophylaxis Develop processes to ensure that first responders, public health responses, critical infrastructure personnel, and their families receive prophylaxis prior to POD opening Develop processes for coordinating with treatment centers Establish protocols for individuals receiving medications (e.g., number of doses, identification Establish processes for obtaining and distributing investigation new drug (IND) consent forms at Target Capabilities List
479
Develop credentialing mechanisms for volunteers and staff at mass prophylaxis dispensing sites Develop programs to ensure security of mass prophylaxis during dispensing operations Identify and address legal issues regarding authorizations for mass prophylaxis practitioners Establish processes for communicating with the public regarding nature of event and mass Res.C2a 1.3.3.1 prophylaxis operations in coordination with Emergency Public Information and Warning Preparedness Measures
Percent of state/local plans that contain elements included in the State/Local SNS Mass prophylaxis plan is incorporated into overall emergency response plan Plan addresses requesting and receiving Mass Prophylaxis from the State and/or CDC. Plan addresses the distribution of mass therapeutics (e.g. Points of Dispensing, medical Plan addresses cultural characteristics of populations to be treated (e.g. religious needs, Plan addresses the provision of prophylaxis to special needs populations (e.g. disabled people, quarantined individuals, people requiring ongoing medical support). Plan addresses infection control measures to protect staff and patients (e.g. medical screening is performed in separate area away from mass prophylaxis site). Frequency with which mass prophylaxis plan is reviewed and updated Mass prophylaxis plan incorporates input from all relevant stakeholders, including health department, emergency management agency, public works, department of transportation, law enforcement, EMS, fire, hospitals, military installations, department of finance) Treatment center point of contact is identified and documented in mass prophylaxis plan Mass prophylaxis plan provides authorization for practitioners to issue standing orders Mass prophylaxis plan provides authorization for practitioners to dispense medications Activity: Develop and Maintain Training and Exercise Programs
RESPOND MISSION: MASS PROPHYLAXIS
Critical Tasks
Develop and implement training for mass prophylaxis operations Conduct training of all key personnel on fundamentals of NRP, ICS and NIMS Develop and implement training for key personnel on tactical communications during mass Develop and implement training on public information and communication for mass prophylaxis Develop and implement training on security of mass prophylaxis Develop and implement training for mass prophylaxis inventory management 480
Target Capabilities List
Develop and implement training for mass prophylaxis repacking, distribution, and dispensing Create and implement plans and drills for mass prophylaxis Preparedness Measures
Exercises evaluate the tactical communications portion of the mass prophylaxis plan Exercises evaluate the public information and communication portion of the mass Exercises evaluate the mass prophylaxis plan procedures to maintain security Exercises evaluate the mass prophylaxis inventory management system plan Exercises evaluate the mass prophylaxis plan procedures to distribute prophylaxis Exercises evaluate the mass prophylaxis dispensing procedures RESPOND MISSION: MASS PROPHYLAXIS
Exercises evaluate the treatment center coordination plan Frequency with which all key emergency and public health personnel to include Leaders and POD Managers are trained in accordance with identified training plans Frequency with which at least one full scale POD exercise to test Mass Prophylaxis Performance Tasks and Measures/Metrics
Activity: Direct Mass Prophylaxis Tactical Operations
Definition: In response to notification of a mass prophylaxis incident, provide overall management
and coordination of mass prophylaxis operations
Critical Tasks
Coordinate dispensing/administration of mass prophylaxis Coordinate public information releases regarding location of PODs Coordinate with the Medical Supply and Distribution Capability to ensure that medical stockpile warehouses can re-supply Points of Dispensing (PODs) as needed Coordinate with public information agencies to disseminate health and safety information to the Coordinate mass prophylaxis to functional and medical support sheltering locations for special needs populations Coordinate with law enforcement to provide security to protect medicines, supplies, and public health personnel Establish and maintain tactical equipment and communication networks including establishing redundant systems Coordinate Point of Dispensing (POD) locations and hours of operations Establish shift change procedures to ensure continuity of operations Performance Measures
Percent of public health personnel who arrive safely within target timeframe to perform Target Capabilities List
481
Percent of PODs that completely deplete all medical resources prior to re-supply Time in which public is provided with accurate and consistent information messages Testing and functionality of tactical equipment and communication networks is The availability of the intervention is not affected by supply chain or other logistical Percent of population covered by PODs that are secured, open, and prepared to serve Activity: Activate Mass Prophylaxis Dispensing Operations
Definition: Upon notification, activate points of dispensing for mass prophylaxis operation
Critical Tasks
Implement local, regional, and State plans for distributing and dispensing prophylaxis. This should include procedures for requesting federal SNS assets when state and local caches and other available resources have been depleted Initiate staff call down lists for POD operations Ensure POD site operations are established in accordance with POD specific plans and protocols Provide internal and external security for POD sites Have or have access to information systems that support tracking mass prophylaxis allocation that comply with the Public Health Information Network (PHIN) functional requirements for Countermeasure and Response Administration Assemble needed supplies and equipment for POD operations including materials to prepare oral Implement the plan to provide mass prophylaxis to functional and medical support sheltering locations for populations with disabilities, etc. Performance Measures
Percent of sufficient, competent personnel available to staff dispensing centers or vaccination clinics, as set forth in SNS plans and State/local plans RESPOND MISSION: MASS PROPHYLAXIS
Time for all first shift staff to be at the POD Site and ready Time for all equipment and operational supplies to be in place Percent of security forces designated in the POD specific plan who report for duty 482
Target Capabilities List
Activity: Establish Points Of Dispensing
Definition: Set up POD to receive members of the general public, according to POD plan
Critical Tasks
Implement processes for providing prophylaxis for public health responders and their families Implement processes for providing prophylaxis for first responders and critical infrastructure personnel and their families prior to opening POD to general population Ensure adequate staffing levels for anticipated mass prophylaxis throughput Implement processes for obtaining and distributing mass copies of IND protocol consent forms at RESPOND MISSION: MASS PROPHYLAXIS
Post signage to inform and direct the public Res.C2a 5.1.3.1 Implement processes to ensure the mobility impaired populations have access to PODs Performance Measures
Percent of POD staff, first responders, and critical infrastructure personnel and their families given prophylaxis prior to POD opening to general public Percent of PODs that are easily accessible and fully functional Percent of IND drugs dispensed that have corresponding consent forms Percent of population directed to appropriate stations Activity: Conduct Triage for Symptoms
Definition: Conduct initial screening of individuals prior to their entering the POD
Critical Tasks
Establish number of triage stations to commensurate with the anticipated size of the throughput Ensure symptomatic individuals are directed to appropriate treatment facility Transport or direct symptomatic individuals to appropriate health facility prior to their entering Ensure that personnel conducting triage and other persons in the area are not exposed to disease Performance Measures
Time in which clinical staff and volunteers become available at triage station Within 4 hours from decision to activate site Transportation assets are available to bring symptomatic individuals to appropriate Target Capabilities List
483
Activity: Conduct Medical Screening
Definition: Review patient screening documentation and available medical history to determine
proper course of treatment
Critical Tasks
Ensure proper documentation is created for each individual receiving prophylaxis Identify appropriate prophylaxis based on medical history and exposure Ensure sufficient staffing at the POD site screening station to prevent initial bottlenecks Take appropriate actions for individuals for whom prophylaxis is determined to be inappropriate Performance Measures
Time in which clinical staff and volunteers become available at medical screening station Within 4 hours from decision to activate site Percent of people dispensed the appropriate drug Activity: Conduct Mass Dispensing
Definition: Dispense oral medication/administer vaccination according to standing medical orders
Critical Tasks
Dispense the appropriate medication and dosage to the population, including children, infants Maintain a system for inventory management to ensure availability of critical prophylaxis Ensure adequate supply of pharmaceuticals, ancillary medical supplies and drug information Ensure availability of and distribute pre-printed drug information sheets Distribute IND consent forms as needed for mass prophylaxis/vaccine administration RESPOND MISSION: MASS PROPHYLAXIS
Performance Measures
Percent of dispensing centers or vaccination clinics that are able to process patients at the rate (persons per hour) specified in SNS Plans and State/Local Plans Percent of at-risk population that was successfully provided initial prophylaxis within 48 hours of State/local decision to provide prophylaxis Dispensing is not interrupted due to lack of preparation, availability of forms and Percent of patients who are transported from station to station within times specified in Percent of parents receiving appropriate dosage and/or instructions to prepare oral suspensions for their children according to FDA Guidelines 484
Target Capabilities List
Percent of individuals receiving appropriate medication Activity: Monitor Adverse Events
Definition: Through monitoring, identify individuals who have an adverse reaction to prescribed
medication and initiate appropriate medical care
Critical Tasks
Continue to track outcomes and adverse events following mass distribution of prophylaxis Provide alternate medication as ordered by clinician Access information systems that support monitoring of adverse reactions that comply with the RESPOND MISSION: MASS PROPHYLAXIS
PHIN functional requirements for Countermeasure and Response Administration Establish a call center to triage individuals to receive appropriate medical care in case of an Performance Measures
Percent of patients who receive instructions for adverse event reaction Adverse event monitoring system is in place Number of staff or mechanisms to monitor individuals is adequate based on number of Activity: Demobilize Mass Prophylaxis Operations
Definition: Upon completion, stand down POD operations, return site to normal operations, and
release or redeploy staff
Critical Tasks
Performance Measures
Percent of staff debriefed after mass prophylaxis distribution
Linked Capabilities
Linked Capability
Relationship
Emergency Public Information Mass Prophylaxis provides releasable public information of POD sites and other and Warning relevant information to Emergency Public Information and Warning for public notification. Target Capabilities List
485
Linked Capability
Relationship
Emergency Operations Center Management provides situation reports to Mass Prophylaxis, which provides situation reports in return. Medical Supplies Management Medical Supplies Management and Distribution provides medical assets to Mass and Distribution Prophylaxis, including the request for SNS and the receipt, staging, and storage of mass prophylaxis Emergency Public Safety and Security Response provides perimeter security and crowd/traffic control for Mass Prophylaxis. Epidemiology Surveillance and Epidemiology Surveillance and Investigation provides information for Mass Investigation RESPOND MISSION: MASS PROPHYLAXIS
486
Target Capabilities List
Provide SNS/medical assets; provide site provide RESPOND MISSION: MASS PROPHYLAXIS
Transport symptomatic to definitive medical care Appropriately reduce number of POD(s) and staff Target Capabilities List
487
Resource Element Description
Resource Elements
Components and Description
Command and control center based on incident command system (ICS) functions (planning, logistics, operations, finance/administration and information) Locations where prophylaxis will be provided. Includes all equipment and trained and available fulltime staff and volunteers to include: clinicians/public health professions; ancillary support personnel, traffic control personnel, security personnel, inventory assistants, and staff for storing, receiving and distributing federal medical supplies and equipment to fully staff 24 hour operations at each POD Pharmaceuticals, medical supplies and materials, available from local, state and federal stockpiles. This may include follow-on managed inventory (MI) supplies Triage call center system and personnel equipped to address affected populations who have had an adverse reaction. Vaccines and drugs used under the IND protocol require monitoring and reporting of such adverse events. Monitoring and reporting the adverse effects of IND vaccines and drugs are the joint responsibility of designated State adverse event coordinators and the CDC through established mechanisms Planning Assumptions
ƒ Assume population potentially exposed and requiring prophylaxis is 2 million in one Metropolitan Statistical Area (MSA). Additional geographic locations would require resource considerations according to population estimates in affected areas. RESPOND MISSION: MASS PROPHYLAXIS
ƒ Additional illnesses will occur prior to mass prophylaxis campaign. Many people are likely to present who fear they might have been exposed multiple unexplained physical symptoms (MUPS). Due to time elapsed prior to plan execution and non-informed public. Studies show that between 4 and 50 times as many people seek medical care after an event for MUPS than for diagnosable symptoms treatable by medical providers. ƒ State/local medicines and medical supplies are insufficient for mass prophylaxis. ƒ Federal medical assets are requested and received at each location within 12 hours from the Federal ƒ Adequate prophylaxis is readily available from the Strategic National Stockpile; initial 10-day regimen with ciprofloxacin (Cipro) or doxycycline (Doxy). Amoxicillin (10-day regimen) is also available based on antimicrobial sensitivity results. Goal is to protect exposed or potentially exposed population as quickly as possible based on current Centers for Disease Control (CDC) recommendations for anthrax prophylaxis. 488
Target Capabilities List
ƒ Follow-on prophylaxis with vaccine and antibiotics (50-day supply) for persons at highest risk of exposure based on epidemiological data and current CDC recommendations for anthrax prophylaxis. ƒ State/locals have sufficient personnel to fully command or staff a mass prophylaxis dispensing operation. This may include assistance from Federal response teams, if requested. ƒ State/locals have developed and exercised both and emergency response plan and a Mass Prophylaxis ƒ Guidelines for post exposure prophylaxis populations will be developed by public health officials and subject matter experts depending on epidemiological circumstances. Decision will be based on estimates of timing, location and conditions of exposure. ƒ Point of Distribution (POD) Staffing: Number of PODs determined assumes 24 hour operation, population equally distributed among PODs, performance at 100% capacity at all times, constant flow of people, staffing is constant and adequate. PODs should be located where easily accessible to the public i.e., publicly owned buildings. RESPOND MISSION: MASS PROPHYLAXIS
ƒ Medical Assets/Supplies – Adequate prophylaxis and medical supplies are readily available in the ƒ Due to limited pediatric suspension, states have established MOAs with local compounding pharmacies and are prepared to use the FDA’s crushing guidelines to enhance pediatric prophylaxis capability. ƒ The regulatory mechanism for providing investigational product(s) for Mass Prophylaxis may be under an IND or an Emergency Use Authorization. ƒ States will be prepared for both IND and EUA regulatory channels. ƒ Population Centers – resources readily available for largest urban areas for duration of prophylaxis ƒ Receiving, Staging, and Storing (RSS) – State/local jurisdictions with mass prophylaxis plans have identified a site for receiving, staging, and storing Federal assets. In some worse case scenarios, more than one site may need to be identified. The occurrence of multiple events could deplete the availability of Federal stockpiled medical assets and Federal resources i.e., staff, supplies, etc. The unavailability of staff and volunteers to operate the POD system. Inadequate planning for mass prophylaxis would result in delays in response and ultimately risk of loss of life. Planning Factors from an In-Depth Analysis of a Scenario with Significant
Demand for the Capability
Resource
Estimated
Scenario
Quantity of
Organization
Capacity
Requirement
Resources Needed
Prophylaxis medicines Federal assets from SNS Target Capabilities List
489
Resource
Estimated
Scenario
Quantity of
Organization
Capacity
Requirement
Resources Needed
Approaches For Large-Scale Events
The information and analysis included in this capability reflects only one of the 15 scenarios - aerosolized anthrax. Target Capability Preparedness Level
Resource
Unit Measure
Capability
Element Unit
(number per x)
Activity
supported by
RESPOND MISSION: MASS PROPHYLAXIS
Conduct Mass Dispensing Conduct Adverse Events Monitoring 490
Target Capabilities List
Resource
Unit Measure
Capability
Element Unit
(number per x)
Activity
supported by

References
1. Homeland Security Presidential Directive/HSPD–8: National Preparedness. The White House, Office of the Press Secretary. December 2003. http://www.whitehouse.gov/news/releases/2003/12/20031217-6.html. RESPOND MISSION: MASS PROPHYLAXIS
2. National Response Plan. U.S. Department of Homeland Security. December 2004. 3. National Incident Management System. U.S. Department of Homeland Security. March 2004. http://www.dhs.gov/interweb/assetlibrary/NIMS-90-web.pdf. 4. Modular Emergency Medical System: Concept of Operations for the Acute Care Center. U.S. Army Soldier and Biological Chemical Command, Biological Weapons Improved Response Program. Maryland. May 2003. 5. Resource Typing Definitions–I: First 60 Resources. National Mutual Aid and Resource Management Initiative. U.S. Department of Homeland Security, Federal Emergency Management Agency. January 2004. http://www.fema.gov/pdf/preparedness/initial_60_rtd.pdf. 6. Emergency Response Training Necessary for Hospital Physicians/Nurses That May Treat Contaminated Patients. Standard interpretation. Occupational Safety and Health Administration. March 1999. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=22710. 7. Emergency Response Training Requirements for Hospital Staff. Standard interpretation. Occupational Safety and Health Administration. April 1997. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=22393. 8. Hazardous Waste Operations and Emergency Response, 29 CFR 1910.120. Occupational Safety and Health Administration. November 2002. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9765. 9. Medical Personnel Exposed to Patients Contaminated with Hazardous Waste. Standard interpretation. Occupational Safety and Health Administration. March 1992. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=20609. 10. Training Requirements for Hospital Personnel Involved in an Emergency Response of a Hazardous Substance. Standard interpretation. Occupational Safety and Health Administration. October 1992. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=20911. 11. Mass Antibiotic Dispensing-Managing Volunteer Staffing. Centers for Disease Control and Prevention. December 2004. http://www.phppo.cdc.gov/PHTN/webcast/antibiotic2/default.asp. 12. Mass Antibiotic Dispensing: A Satellite Web Cast Primer. Centers for Disease Control and Prevention. June 2004. http://www.phppo.cdc.gov/phtn/antibiotic/default.asp. 13. U.S. Postal Service May Deliver Medicine in the Event of a Catastrophic Incident. Memorandum of understanding between the U.S. Departments of Homeland Security and Health and Human Services and the U.S. Postal Service. February 2004. http://www.usps.com/communications/news/press/2004/pr04_015.pdf#search='U.S.%20POSTAL%20SERVICE%20MAY%20DELIVER%20MEDICINE. 14. DHS, Office for Domestic Preparedness, Metropolitan Medical Response System (MMRS) program, 15. Receiving, Distributing, and Dispensing Strategic National Stockpile (SNS) Assets: A Guide for Preparedness, Target Capabilities List
491
16. “Community-Based Prophylaxis. A Planning Guide for Public Health Preparedness.” Weill Medical College of Cornell University, Department of Public Health, August 2004. 17. Hupert, Nathaniel. Modeling the Public Health Response to Bioterrorism: Using Discrete Event Simulation to Design Antibiotic Distribution Centers, in a September-October 2002 supplement to Medical Decision Making (Med Decis Making 2002:22(Suppl): S17-S25). 18. “PHIN Preparedness - Countermeasure/Response Administration Functional Requirements”, Version 1.0, Centers for Disease Control and Prevention, April 2005. 19. “State and Local Technical Assistance Review Tools, Centers for Disease Control and Prevention, September RESPOND MISSION: MASS PROPHYLAXIS
492
Target Capabilities List

Source: http://www.health.mesacounty.us/APC2/pdf's/Target%20Capabilities/Mass%20Prophylaxis.pdf