Click above link to see the CDC's Guidance for Post-Event Smallpox Planning
on the Government web site , or read the web page below which is taken from the
CDC.
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CONTEXT
Described below are the likely stages of a smallpox outbreak and the
critical responses required by state and local public health agencies. This
information is intended as a context to aid state and local planners in
developing a post-event smallpox plan. The activities listed may occur in the
context of with many other activities in collaboration with a wide range of
federal, state, and local agencies, organizations, elected officials. In some
circumstances smallpox outbreak response activities may be placed under
decision making structures outside of normal public health authorities,
including the lines of command and control specified by the Federal Response
Plan, if it is activated. Planners should review the of the Federal Response
Plan, Emergency Support Function 8 (ESF-8) and its state and local equivalents
to understand how responsibilities will be divided between public health and
emergency management agencies if a significant public health threat occurs.
1. Isolation, and treatment of cases – Suspected and
confirmed cases will need to be quickly moved to facilities that provide
appropriate health care and isolation to prevent additional spread of
smallpox.
2. Diagnosis – Rapid preliminary diagnosis can be based
on clinical characteristics of the illness with sequential laboratory
confirmation at regional (Laboratory Response Network (LRN)) laboratories
and confirmation of the diagnosis at CDC.
3. Vaccination of public health and healthcare response personnel
and first responders in affected communities – A large number of
public health personnel, e.g., public health and law enforcement personnel
and first responders, will be needed to control the outbreak, and healthcare
workers will be needed to diagnose, manage, and treat cases are likely to be
exposed to smallpox cases as part of their work responsibilities. These
individuals must be vaccinated as soon as possible after the first case is
confirmed. For additional information on prioritization of health care
workers for vaccination, see
ACIP Smallpox Vaccination Recommendations, October 21, 2002.
4. Surveillance for new cases – It will be important to
quickly and efficiently diagnose new cases to ensure that the ring
vaccination program (below) will quickly control the outbreak.
5. Containment Activities that would include:
a. Contact and contact of contact tracing -
Identification of contacts of smallpox cases (contact with cases beginning
with the initial symptoms (fever)) and household contacts of these
contacts will need to be identified, vaccinated and isolated if they
develop illness. Contacts of cases should be vaccinated as soon as
possible to maximize the effectiveness of post exposure vaccination and
minimize the number of new cases. (With a highly suspicious clinical case
of smallpox this can be done while diagnostic confirmation is being done).
It will also be important to track patient movement (where they have been)
after onset of symptoms and identify all possible contacts of the case.
b. Vaccination and monitoring of contacts – Post exposure
vaccination may prevent or ameliorate disease and vaccination may protect
from additional exposures from other contacts that develop smallpox.
Contacts are monitored for illness to ensure that they can be isolated to
prevent transmission to others and given appropriate medical care, if they
develop smallpox.
c. Community vaccination – It may be necessary to
vaccinate all persons in exposed communities in addition to contacts and
household contacts of contacts.
6. Epidemiologic investigation - Any potential linkages
between the patients (review travel history for 2-3 weeks prior to symptom
onset) must be identified to determine if there is a common source for
exposure and to determine if any additional persons may have been exposed to
initial source (so they can be traced and evaluated for illness or watched
for illness onset - if ill, isolate and vaccinate their contacts (identify
contacts similar to above), if not already ill, and to ensure that all who
need to be included in the ring vaccination program are included.
7. Large Scale vaccination - A decision may be made by
public health officials and/or political leaders to offer vaccine to all
persons within the city, county or state. Although smallpox vaccine is not
currently licensed, plans should be developed with the assumption that the
vaccine will have been licensed by the time a smallpox event occurs or that
emergency provisions will be enacted so that smallpox vaccine can be
administered without adherence to an investigational new drug protocol.
8. Information Management - Detailed information will be
needed on an ongoing, real-time basis to inform policy makers, health
officials, clinic managers, and the public about the status of smallpox
response activities. Data must be analyzed and shared continuously to enable
managers at all levels to identify and resolve problems, evaluate progress
toward program objectives and redirect the activities, as necessary.
9. Communications - To address public questions,
minimize false rumors and misinformation, and reassure the public that the
public health system is responding effectively, it is imperative that public
health officials acknowledge the seriousness of a smallpox outbreak and
provide accurate, timely information to the public through the media.
Although smallpox vaccine is not currently licensed by the Food and Drug
Administration, given the short time frame post-event smallpox preparedness
plans should be developed with the over-all assumption that the vaccine will
have been licensed at the time a smallpox event occurs or that emergency
provisions will be enacted so that smallpox vaccine can be widely
administered. However, plans should also acknowledge the possibility that
vaccinations may be given under an IND protocol and, therefore should also
briefly address an approach for rapid consenting procedures (in groups, if
necessary) and monitoring of vaccinee take rates and adverse events. Planners
should also assume that vaccine will be delivered only by specialized
vaccination clinics (as opposed to by individual private providers) and that
liability concerns related to administration of smallpox vaccine will be
addressed on a national basis. Additional information, on vaccination
operations under an IND are provided in Annex 3 of the CDC Smallpox Response
Plan and Guidelines (SRPG) which can be accessed at
www.bt.cdc.gov/agent/smallpox/response-plan/index.asp.
PREPAREDNESS CAPACITIES
Described below are some basic concepts related to the critical preparedness
capacities required to control a smallpox event. Also listed are examples of
plan elements that can be used as a basis for developing your draft plan.
Additional information about important preparedness activities are described
in
Annex 5 of the SRPG.
Organization and Management
Planning and implementing a post-event smallpox vaccination response will
require state and local public health agencies to establish an organizational
structure for command, control and decision making. Plans should provide a
description how this structure will function within your agency. Examples
include:
- an organizational chart showing the structure and location of a smallpox
response coordinating unit within your agency;
- an emergency response management decision model; · a list of the
positions/individuals assigned responsibility for managing the key
operational functions; and
- a list of key contacts within state, local and federal agencies that
will be involved in smallpox response efforts;
- a process by which your agency will work with hospitals and hospital
organizations to develop a plan for treatment of smallpox cases
Assignment of Staff Roles and Responsibilities
Each grantee should have at least one public health smallpox response team.
Case investigation teams should include a medical expert as team leader,
medical epidemiologists, disease investigators, diagnostic laboratory
scientists, nurses, vaccinators, and other necessary personnel as determined
by state and local officials. All members of the response team(s) must be
vaccinated before they begin control activities. Projects should be prepared
for the possibility that hundreds of public health and public safety workers
could potentially be required to control a smallpox outbreak. In addition to
case investigation teams, each project should identify individuals who will
operate vaccination clinics if a large scale vaccination program becomes
necessary. For additional information about clinic staffing requirements, see
Annex 3 of the SRPG. Plans should cover the following critical
staffing issues:
- the number of response teams, their composition by position title and
agency affiliation;
- a strategy for completing vaccination of all workers involved in control
activities within 1-3 days of the confirmation of the first smallpox case;
- a strategy for ensuring a rapid response throughout the state;
- plans to ensure adequate staffing to receive, provide security for and
distribute vaccine and other National Pharmaceutical Stockpile items;
- plans to add or reassign staff to handle potential influx of specimens
submitted for testing to the state laboratory;
- a description of the sources for clinic personnel (e.g., local health
departments, community health centers, Visiting Nurses Association,
community volunteers); and
- a generic staffing plan for each clinic, including a listing of
individual staff responsibilities.
Enhanced Surveillance, Epidemiology, and Laboratory Testing
Surveillance preparedness will require close collaboration with medical and
hospital organizations and individual hospitals to ensure the rapid reporting
of additional suspected cases of smallpox.
Guide A of the SRPG provides detailed information about
surveillance for smallpox. Enhanced surveillance plans should include:
- plans to enhance surveillance systems after an initial case is confirmed
(within jurisdiction or elsewhere) to ensure rapid identification and
reporting of additional cases; and
- plans to conduct epidemiological analysis to estimate the population at
risk, identify unexpected epidemiological features of the outbreak, and
evaluate the characteristics and extent of the outbreak to develop the most
effective containment and communications strategies.
- plans to enhance laboratory testing capabilities to respond to the need
to quickly diagnose cases of smallpox and differentiate from other illnesses
and adverse reactions to the vaccine.
Identification of Clinic Sites
Each grantee will be responsible for identifying sites for specialized
vaccination clinics to prepare for the possibility that a large number of
vaccinations may need to be administered in a short period of time (e.g.,
within 5-10 days). Although vaccination of contacts of cases may be handled in
the field by case investigation teams, large numbers of contacts and/or
potential contacts may need to be referred to fixed clinic sites or vaccinated
on an ad hoc basis at other convenient locations. Plans should be scalable to
accommodate vaccination of a population ranging from a few hundred persons to
the entire population, depending on the nature, location and size of the
outbreak.
Annex 2 and
Annex 3 of the SRPG provide additional information
concerning selection of clinic sites. State and local agencies should
coordinate this process carefully to ensure appropriate clinic coverage
throughout your jurisdiction and where jurisdictions meet and/or overlap.
Plans should include:
- the criteria used for selecting fixed clinic sites
- a list of potential and confirmed clinic sites; and
- a description of arrangements with neighboring jurisdictions to
vaccinate and follow-up persons who would not have reasonable access to a
clinic within jurisdiction.
Training and Education
Many state and local health departments, hospitals, health care professional
organizations, communication professionals, public safety workers and others
will require general education and training on smallpox and smallpox vaccine
issues. Specific personnel such as clinic screeners, vaccinators, adverse
event responders, communications staff, hotline staff, laboratory workers,
data enterers, and vaccine take readers will need highly detailed information.
While many materials and some centralized training will be provided by CDC on
a preparedness basis, state and local health department personnel will need to
distribute informational and educational materials and undertake the actual
education and training efforts. To this end CDC's training efforts focus on
training-the-trainer. CDC will continue to develop satellite courses, audio
conferences, CD-ROMs, slide sets, vaccination training materials, handouts,
etc. You should consider including a plan for conducting critical training
functions over the next 12 months. Examples of elements in a training plan
include:
- selection and designation of a core of capable public health personnel
who will be trained by CDC to train others;
- curriculum and timeline for training sessions on specific parts of the
implementation plan, venues for training, and specific personnel to be
trained;
- procedures for quickly reproducing and distributing CDC materials;
- the names and positions of the key training and communications partners
(infectious disease or training specialist) who are designated to receive
educational materials and coordinate training activities about disease,
vaccine, adverse events, contraindications, screening process, vaccination
and post vaccination take reading; and
- a plan for providing clinic personnel with national and state-specific
educational materials and training on adverse events and procedures for
responding when patients present with potential adverse events;
Data Management
Consistent data derived from health departments and clinics must be analyzed
continuously to enable managers at all levels to identify and resolve
problems, evaluate progress toward program objectives and redirect the
activities, as necessary. Shortly, CDC will provide grantees with
specifications for smallpox systems and data exchange. This information will
include the functional needs for operating information systems at the grantee
level, specific data formats and terms that need to be exchanged in real-time
with CDC, and process rules for the management of data on vaccination events,
adverse event tracking, cases and case contacts, laboratory results and the
necessary data exchanges for successful system integration. Since the
complexity of the functional information technology needs in these areas is
significant, CDC is developing software to provide to grantees who do not have
the capabilities to address all of these functional needs. To meet immediate
planning needs, grantee plans should cover the following details:
- the name and position of the individual designated to oversee,
coordinate and collaborate with state, local, and CDC data management and
information experts to facilitate full knowledge, understanding, acceptance
and support of the system, its implementation and maintenance, and its
evaluation;
- a description of how patient information will be entered into CDC's
record keeping and data system;
- plans for ensuring adequate electronic connectivity at each clinic site
and other data access areas;
- a description of technical assistance potentially needed from CDC to
support the information technology needs of State and clinic sites; and
- plans to acquire computers, printers and other related supplies for all
vaccination clinic sites and other access points;
- plans for compliance with the Information Technology Functions and
Specifications of the Public Health Information Network (www.cdc.gov/cic/functions-specs)
RESPONSE CAPACITIES
Described below are some basic concepts related to the critical response
capacities required to control a smallpox event. Also listed are examples of
plan elements that may be and, as indicated in some cases, must
be addressed in your plan. Planners should refer to
Guides A-F in the SRPG for detailed
information about the roles of CDC and state and local agencies in responding
to a smallpox outbreak.
Case Investigations
Since smallpox is a contagious disease, the highest priorities for public
health officials are to reduce risk of transmission by immediately identifying
and vaccinating close contacts of cases and isolating the cases. One
confirmed case of smallpox requires urgent detailed case investigation.
Additional information about case investigations is provided in
Guide A of the SRPG. Please include in your plan the following
critical plan elements for identifying clinic sites:
- a smallpox diagnosis classification and case definition;
- procedures for identifying tracing, vaccinating and monitoring contacts;
- plans to impose isolation of confirmed, probable and suspected cases;
- plans to monitor the outcome of confirmed cases; and
- a strategy for maintaining case investigations and
vaccination/monitoring of contacts at all costs despite
demands for large scale vaccination efforts or other urgencies.
Vaccination Strategy
Plans should reflect the vaccination strategy described in
Guide A and
Guide B of the SRPG and the process that will be followed
to expand vaccination of contacts to expanding rings involving the community,
urban areas and ultimately wide area ("mass") vaccination, if necessary.
Please include the following elements in your plan:
- a strategy for vaccinating health care providers and public safety
workers who may be required to play a role in response efforts and who have
not yet been vaccinated;
- the process and procedures for vaccinating and monitoring contacts and
potential contacts;
- a strategy for isolating contacts who refuse vaccination;
- plans for implementing quarantine requirements, if necessary;
- documentation of state legal authority for invoking quarantine; and
- a description of the decision and approval process in concert with CDC
and DHHS for expanding the scope of the vaccination program from
surveillance and containment (ring strategy) to wide area vaccination.
Vaccine Logistics and Security
Each grantee needs to designate a person with overall responsibility and a
clinic based person to be responsible for ensuring the safety of vaccine and
its appropriate handling upon receipt from CDC, transporting to and from
vaccination sites, ensuring appropriate handling and storage of vaccine at the
clinics, and implementing vaccine accountability and usage reporting in
accordance with CDC’s specifications for smallpox information systems and data
exchange (to follow under separate cover). Additional information about
vaccine logistics and security is provided in
Annex 2 and
Annex 3 of the SRPG. All plans should include the following:
- the name and position of an individual who will be responsible for
collaborating with the CDC National Pharmaceutical Stockpile and clinics
concerning receipt, distribution, security, refrigeration, transport,
accountability of the combined vaccine, diluent and bifurcated needle
‘kits’, and the disposal of waste materials;
- plans for documenting and reporting vaccine usage in accordance with CDC
specifications for smallpox information systems and data exchange;
- plans to ensure security of the vaccine during transport and clinic
operations;
- a description of the facilities and refrigeration equipment to store and
continuously monitor the temperature of vaccine;
- a description of how and where vaccine will be held between vaccination
sessions;
- a detailed description of how accountability for vaccine will be
accomplished daily at state and clinic levels; and
- a strategy for minimizing wastage of vaccine by maximizing the number of
doses administered per 100-dose vial.
Clinic Operations and Management
Project planners should establish an integrated clinic strategy and flow
to maximize the efficiency of the clinic.
Annex 2 of the SRPG provides general guidelines for
smallpox clinic operations, and
Annex 3 provides detailed information about clinic
operations for large-scale clinics.) Clinic staff will be responsible for
participating in scheduling of patients, establishing patient flow, record
keeping, educating and screening potential vaccinees, ensuring adequate
educational materials, forms, and other supplies, stocking of medical
supplies, worker safety, obtaining informed consent, vaccine handling,
vaccination, acute medical reaction management, collection/entry of data about
vaccination events into an information system compliant with CDC’s
specifications for smallpox information systems and data exchange (to follow
under separate cover), post vaccination wound management, waste disposal,
advice on adverse events and reporting, completing the vaccinee’s vaccination
card, and evaluating for vaccine take. Plans should provide a description how
smallpox clinics will be managed and operated. Examples include:
- brief job description for each clinic function, including supervisors;
- a clinic flow/operations schematic;
- a strategy for maintaining medical and vaccination supplies and other
equipment, educational and screening materials, forms, and cold storage;
- a plan for providing and maintaining adequate phone lines, telephones,
computers, furnishings (tables, chairs, etc), waste disposal, medical
related supplies, forms and informational materials at each clinic site; and
- a plan for providing adequate crowd control measures and security for
staff and vaccine at each clinic site.
Vaccine Safety Monitoring, Reporting, and Patient Referral
Up to an estimated 30% of vaccinees will feel uncomfortable enough following
vaccination to curtail their normal activities and seek additional information
about their reaction to the vaccination; between 14 and 52 per million
vaccinees may have life threatening side effects; and an estimated 1 to 2 per
million vaccines will die from vaccine-associated side-effects. Some
vaccinees with life threatening side-effects may need short term
hospitalization with a very small proportion needing to receive VIG or perhaps
Cidofovir (both IND drugs). Protocols for use of VIG and Cidofivir and for
evaluation and treatment of neurologic and dermatologic adverse events are
under development by CDC and will be made available when complete. Grantees
should integrate plans for participating in a national and/or hotline(s),
educating providers in clinically diagnosing and treating reactions,
identifying subspecialists in dermatology, neurology, allergy/immunology,
infectious diseases, and ophthalmology to act as referral physicians for
severe adverse event evaluations, hospitalizations, treatment and longer term
follow-up, and collecting, receiving and analyzing state specific data on
adverse events.
Planners should carefully review
Annex 4 of the SRPG for detailed information about vaccine safety
monitoring activities during a smallpox outbreak. CDC’s specifications for
smallpox information systems and data exchange (to follow under separate
cover) will provide additional guidance. Based on these guidelines, plans
should describe how adverse event reports will be managed. The following are
critical plan elements for ensuring vaccine safety monitoring and reporting
and patient referral:
- the name and position of the individual designated to oversee and
coordinate Vaccine Safety monitoring, data collection, data analysis and
appropriate distribution;
- development of a jurisdiction-wide hotline staffed with qualified
medical personnel to medical questions from the public if this service is
not provided at the national level;
- arrangements are made for hotline coverage on a 24/7 basis;
- a process for referring eligible potential vaccinees to medical
providers for additional consultation and laboratory testing, if needed;
- a plan to alert providers about smallpox vaccination, vaccine takes and
adverse event following vaccination, hotline number, referral physicians and
the Vaccine Adverse Event Reporting System;
- a list of the potential subspecialists that will be available to
evaluate, treat and consult on smallpox vaccine adverse events;
- a training plan to ensure that all staff involved in vaccine safety
monitoring are fully aware of their responsibilities and how the other
participants fit into the strategy; and
- a timeline for completing follow-up of persons with adverse events that
is consistent with the CDC’s IND protocol, if applicable.
Communications
In the event of a smallpox outbreak, the public must be assured that
federal, state, and local health officials are effectively responding to the
smallpox emergency. Programs should have plans in place to inform the public,
health professionals, policy makers, partner organizations and the media about
smallpox disease, the status of the outbreak, who should receive vaccine,
where to go for vaccinations, risks of vaccination, and control strategies.
Guide E of the SRPG provides information about
CDC’s communication plans and activities.
Many resources are available to assist grantees in developing smallpox
communication plans. For communication professionals, the following materials
are available from CDC:
- Emergency Risk Communication CDCynergy (cd-rom with risk communication
templates, tools and planning guides.) (Available as cd-rom in January.
Currently usable at
www.orau.gov/cdcynergy/erc)
- Smallpox “Key Facts” Fact Sheet (to be used to support message
development) (Will be provided through NPHIC, ASTHO, NACCHO and other direct
networks.)
- Media resources, telebriefing transcripts at
www.cdc.gov/communication
For the public, the CDC Public Response Hotline (888-246-2675 (English),
888-246-2857 (Español), or 866-874-2646 TTY)) is available. States may
contact the CDC hotline and request state response assistance from the Project
Officer (Judy Gantt) at 404-639-0831, or 404-639-7290. A wide variety of
downloadable and printable documents and images are available to the public at
www.cdc.gov/smallpox.
The following documents and images are available for health care
professionals at www.cdc.gov/smallpox:
- Smallpox Response Plan & Guidelines
- Vaccination Clinic Guide
- Chart: Smallpox Vaccine Adverse Event Rates (from 1968 national and 10
state surveys)
- Adverse Reactions Fact Sheet
- Medical Management Fact Sheet (key facts about the two medications that
may help persons who have certain adverse events: VIG and cidofovir).
- Contraindications Fact Sheet (Overview of conditions that put persons at
higher risk of experiencing adverse reactions)
- Smallpox Vaccination and Adverse Events Training Module
- Smallpox: What Every Clinician Should Know Online Training
- Summary of October 2002 ACIP Smallpox Vaccination Recommendations
- Draft Supplemental Recommendations of the ACIP on the Use of Smallpox (Vaccinia)
Vaccine (June 20, 2002)
- Telebriefing transcript: Public Health Recommendations for Smallpox
Vaccine Use (June 20, 2002)
- Developing New Smallpox Vaccines (Emerging Infectious Diseases 2001
Nov-Dec)
- Vaccinia (Smallpox) Vaccine: Recommendations of the Advisory Committee
on Immunization Practices (ACIP)
- MMWR Recommendations and Reports (2001 Jun)
- Bioterrorism Readiness Plan: A Template for Healthcare Facilities
- Consensus Statement: Smallpox as a Biological Weapon: Medical and Public
Health Management
- Smallpox: Clinical and Epidemiologic Features (Emerging Infectious
Diseases 1999 Jul-Aug)
- Current Status of Smallpox Vaccine (Emerging Infectious Diseases 1999
Jul-Aug)
- Vaccine Administration and Complications (JAMA 1999)
- Reactions to smallpox vaccinations
- Vaccine and Adverse Events Training Module
- Video “Smallpox: What Every Clinician Should Know” (December, 2001)
- Video Webcast “Smallpox Vaccine and Vaccination Strategies” (March 25,
2002)
- Smallpox and Vaccinia (Vaccines. 3rd ed. W.B. Saunders Company. 1999)
In the event of a smallpox event, individual states would use systems
developed under Focus Area F of state terrorism preparedness grants to
communicate with the public through the media and community-based outlets.
Therefore, smallpox preparedness plans should include:
- communication across state and local agencies and all hospitals and
other partner groups participating in the state’s smallpox response plan.
- a pool of clinically trained personnel that will be dedicated to
responding to a large volumes of calls from state and local health care
professionals involved in the response; (as indicated above, public calls
may be directed to the CDC Public Response Hotline.)
- arrangements for translation/interpretation services for special
populations requiring information in languages other than English.
In general, all information presented in these pages and
all items available for download are for public use. However, you may
encounter some pages that require a login password and ID. If this is the
case, you may assume that information presented and items available for
download therein are for your authorized access only and not for
redistribution by you unless you are otherwise informed.
