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
(Espa�ol), 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
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