Transcript Strategic National Stockpile & Pharmaceutical Response

South Carolina Area Health Education Consortium
Pharmaceutical Response
to a Terrorist Attack
and
Strategic National Stockpile
South Carolina Area Health Education Consortium
Acknowledgements
• South Carolina Area Health Education
Consortium (AHEC)
– Funded by the Health Resources and Services
Administration.
• Grant number: 1T01HP01418-01-00
– P.I. : David Garr, MD, Executive Director AHEC
– BT Project Director: Beth Kennedy, Associate Program
Director AHEC
– Core Team:
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BT Co-director: Ralph Shealy, MD
BT Project Manager: Deborah Stier Carson, PharmD
BT CME Director: William Simpson, MD
IT Coordinator: Liz Riccardone, MHS
Web Master: Mary Mauldin, PhD
P.R Coordinator: Nicole Brundage, MHA
Evaluation Specialist: Yvonne Michel, PhD
Financial Director: Donald Tyner, MBA
South Carolina Area Health Education Consortium
Acknowledgment
This material has been prepared for
SC AHEC Bioterrorism Training Network
by
Deborah Stier Carson, PharmD, BCPS
Program Manager of SC AHEC
Bioterrorism Training Network
Professor Emerita, College of Pharmacy
Medical University of South Carolina
South Carolina Area Health Education Consortium
Objectives
• List the pharmacologic agents that may be used to
limit the impact of biological and chemical public
health emergencies.
• Outline the purpose and function of the Strategic
National Stockpile.
• Describe how to contact the appropriate local or
state agencies to report potential bioterrorism or
other public health concerns.
• Outline the expanded role for the pharmacist in
the event of a bioterrorism or public health
emergency.
South Carolina Area Health Education Consortium
Definition of
Bioterrorism Classes
• Bacteria:
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Anthrax
Brucellosis
Cholera
Glanders
Plague
Tularemia
Q Fever
• Viruses
– Small Pox
– Venezuelan Equine
Encephalitis
– Viral Hemorrhagic Fevers
• Toxins
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Botulinum
Staphylococcal Enterotoxin B
Ricin
T-2 Mycotoxins
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Antibiotics to
Counteract Biologic
Weapons
• Often older agents are still the most
effective.
• Dosage regimens vary depending on
– Bacterial agent being treated
– Treatment v prophylaxis
• Most expensive drug is not
necessarily better !
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Ciprofloxacin
• Anthrax:
– Treatment: 400mg IV q8-12h
– Prophylaxis: 500mg PO bid x 4 wks;
vaccinate
• Plague
– Prophylaxis: 500mg PO bid x 7 days
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Doxycycline
• Anthrax:
– Tx: 200mg IV then 100mg IV q8-12h
– Prophylaxis:100mg PO bid x 4 wks; vaccinate
• Plague:
– Tx: 200mg IV then 100mg IV x 10-14 days
– Prophylaxis:100mg PO bid x 7d or duration of
exposure
• Q-fever
– Tx: 100mg PO bid x 5 - 7 days
– Prophylaxis: start 8-12 days post exposure x 5 days
• Tularemia
– Prophylaxis:100mg PO bid x 14d
South Carolina Area Health Education Consortium
Drug Use In Pregnancy
• Tetracyclines and quinolones are
contraindicated in pregnancy
– Benefits v Risks
– Tetracycline:
• Maternal heptatoxicity (rare)
• Discoloration of deciduous teeth
• Discoloration of growing bone
– Quinolone
• Bone toxicity in beagle pups
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When alternatives are available,
these agents should be avoided in
pregnant women or young children.
However, acts of bioterrorism
shift the benefit
such that these agents should
NOT be excluded as viable treatments
in these populations if the accepted
alternatives are not available.
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Contraindications
• ALL contraindications need to
be reassessed in the event of a
bioterrorism event.
South Carolina Area Health Education Consortium
Other Antibiotics
• Sulfadiazine
– Glanders
• SMP/TMX
– Glanders
• Streptomycin
– Tularemia
– Plague
• Penicillin / Amoxicillin
– Anthrax
South Carolina Area Health Education Consortium
Emergency Use of Bleach in
Anthrax Decontamination
• Do Not Decontaminate a Crime Scene.
– Anywhere a biologic WMD is thought to be
present automatically becomes a crime scene
with very specific procedures that must be
followed by law enforcement, including
decontamination.
– Bleach must be applied in accordance with
use instructions from Federal, State, or local
emergency response personnel following a
plan that include steps to ensure proper
gathering of evidence prior to
decontamination.
South Carolina Area Health Education Consortium
Anti-virals
• Viral hemorrhagic fever
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Ribavirin
Supportive care for victims
Vaccine – investigational
Universal blood /bodily fluids precautions to
prevent spread !!
• Smallpox
– Immune globulin – chemoprophylaxis
– Vaccination - prevention
South Carolina Area Health Education Consortium
Smallpox Vaccination
• Prior to 1985
– Americans were REQUIRED to
receive smallpox vaccination.
– Low and acceptable rate of adverse
side effects
– Multiple smallpox vaccinations
without significant adverse effect
– the number of immunologically compromised
individuals in the population was very small.
South Carolina Area Health Education Consortium
Smallpox Vaccination
• As we enter the 21st Century
– large population of immunologically
compromised individuals.
– very susceptible to communicable
diseases
– exposure to inoculation site which has
not yet healed could trigger generalized
vaccinia and death
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Smallpox
Vaccination
• Prior smallpox vaccination affords some
level of protection, but….
• If a confirmed case of smallpox is
diagnosed anywhere, the entire population
who have no contraindications will likely
be vaccinated.
• Sufficient smallpox vaccine is available
for entire US population
South Carolina Area Health Education Consortium
Contraindications to
Smallpox Vaccination
• For vaccinees and their close
household and sexual contacts
– Eczema or atopic dermatitis
(and other acute, chronic, or exfoliative
skin conditions)
– Immunodeficiency or
immunosuppression
(natural or iatrogenic)
– Pregnancy
South Carolina Area Health Education Consortium
Contraindications to
Smallpox Vaccination
• For vaccinees only:
– Previous allergic reaction to smallpox
vaccine or any of the vaccine’s
components
– Moderate or severe acute illness
– Children under 12 months of age
– Breastfeeding
– Heart disease
South Carolina Area Health Education Consortium
All contraindications
to vaccinations will be
reconsidered
in a smallpox emergency.
South Carolina Area Health Education Consortium
Current Status of
Voluntary Vaccination
Program
• The federal government indemnifies individuals
who administer smallpox vaccinations (and their
employers) against liability for adverse effects of
the vaccination.
• For now, only those who will administer
smallpox vaccinations (DHEC personnel and
individuals trained by DHEC) and hospital
personnel who will care for smallpox victims in
the early days of a smallpox epidemic have been
vaccinated.
• In Jan 2004, voluntary vaccine administration
will be expanded to include traditional first
responders and community physicians and staff.
South Carolina Area Health Education Consortium
Vaccination Concerns
for Healthcare Providers
• Providers with unhealed vaccine sites
pose a minimal risk for close contacts.
– CDC states that proper use of the Tegaderm
bandage allows direct patient contact.
– Uncertain liability and questions as to
whether indemnification would be provided
by government or covered by insurance.
• In other states, hospitals have elected not
to vaccinate employees for this reason
– Majority of SC hospitals participate in
vaccination.
South Carolina Area Health Education Consortium
Other
Vaccines
• Anthrax
– Multi-dose
– Annual booster
– Limited usefulness
for prevention
in general population
• Numerous vaccines being investigated
• CDC: National Immunization Program
– Good site for information
– http://www.cdc.gov/nip/
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Toxins
• Decontamination
• Supportive care
• Anti-toxin when available
– Botulism: depending on serotype
• Investigational vaccines:
– Botulism
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Chemical Agents
• Nerve agents: acetylcholinesterase inhibitors
– Sarin, Tabun
– Organophosphates (e.g. insecticides)
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Cyanide
Lewisite: blistering agent
Sulfur mustard: blistering agent
Phosgene: pulmonary toxin
Chlorine: pulmonary toxin
South Carolina Area Health Education Consortium
Antidotes
• Cyanides:
– Amyl nitrite, sodium nitrite, sodium thiosulfate
– Experimental in US:
4-dimethylaminophenol, dicobalt edetate
• Lewisite:
– Dimercaprol (BAL)
• Sulfur mustard, phosgene, or chlorine:
– No specific antidotes
– Supportive and treat associated complications
• Nerve agents, organophosphate
insecticides
– Atropine and pralidoxime
South Carolina Area Health Education Consortium
“Military Grade”
Organophosphate Poisoning
• Miosis, salivation, and bronchospasm
• Decontamination is with hypochlorite and
fluid irrigation.
• Large doses of antidote may be required
– Atropine - up to 20 to 30 mg and
– Pralidoxime - up to 8 g IV
– Rapid IM auto injectors (military)
• Benzodiazepine
– midazolam or diazepam
South Carolina Area Health Education Consortium
Atropine as an Antidote
Validated rapid reformulation from bulk powder
• Commercial vials: 0.4mg/ml or 1mg/ml
– 6 mg dose could not be administered IM
– Stocks will deplete rapidly
• Reconstitute from bulk powder
– 2mg/ml concentration
– Much less expensive
($11 powder v $5000 prefill)
– Maintained potency
• 8 weeks (refrig) / 4 weeks (room temperature)
Geller et al. Ann Emerg Med 2003; Vol 41, No 4.
Kozak et al. Ann Emerg Med 2003 Vol 41, No 5.
South Carolina Area Health Education Consortium
Cyanide Antidote
• Symptoms:
– hyperpnea and cardiovascular collapse
• Amyl nitrite (inhaled)
– as temporizing agent pending IV access
• Sodium nitrite, sodium thiosulfate
– Must be administered rapidly and most
must be given intravenously, usually in
large volumes.
South Carolina Area Health Education Consortium
Antidote for Lewisite
• Topical exposure
– Topical dimercaprol
– Immediate decontamination
• Systemic toxicity
– Dimercaprol
• Intramuscularly
– Painful, high risk of toxicity
• Severe drug reactions
• No effect on skin lesions.
South Carolina Area Health Education Consortium
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Supportive Care
for Chemical Agent
Exposure
Eye care
Attention to skin lesions
Supplementary oxygen
Bronchodilators
Pulmonary toilet
Positive pressure ventilation
Treatment of complicating infections
Monitoring
– up to 24 hours may be indicated after
exposure to sulfur mustard and pulmonary
agents to detect latent or escape syndromes
South Carolina Area Health Education Consortium
“Pills to the People”
The Problem with
Stockpiling
• Antidotes and treatments are
expensive
• Have limited shelf-lives
• Unlikely to be used in large
quantities
South Carolina Area Health Education Consortium
Terrorism or
Large Scale Natural Disaster
• Requires rapid access to large quantities of
pharmaceuticals and medical supplies
– Not normally readily available
– Few state or local governments have the resources to
create sufficient stockpile
• Creation of national pharmaceutical stockpile:
Congressional charge to Health and Human
Services and Centers for Disease Control and
Prevention in 1999
– Re-supply of large quantities of essential medical
materiel to states and communities during an
emergency within 12 hours of the federal decision to
deploy.
South Carolina Area Health Education Consortium
Strategic National Stockpile
(Homeland security act of
2002)
• Tasked DHS with defining the goals and
performance requirements and managing
the deployment of assets.
– Effective on 1 March 2003, the NPS became
the strategic national stockpile (SNS)
managed jointly by DHS and HHS.
– The SNS program works with governmental
and non-governmental partners to upgrade the
nation’s public health capacity to respond to a
national emergency.
– Critical is ensuring capacity to receive, stage,
and dispense SNS assets
• Federal, state, and local levels
South Carolina Area Health Education Consortium
Strategic National Stockpile
• Repository of
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Antibiotics
Vaccines
Immunoglobulins
Chemical antidotes
Antitoxins
Life-support medications
IV administration
Airway maintenance supplies
Medical/surgical items
South Carolina Area Health Education Consortium
SNS: Push
Packages
• Strategically located
throughout US
• Supplement and
re-supply state and local public
health agencies in the
event of a national emergency
• When: Anywhere and Anytime
• Where: Within the U.S. or its
territories
South Carolina Area Health Education Consortium
SNS:
Fast and Flexible
• First line:
Push Packages
– Caches of pharmaceuticals, antidotes, and
medical supplies
– Designed to provide rapid delivery of a broad
spectrum of assets for an ill defined threat in
the early hours of an event.
– Positioned in strategically located, secure
warehouses
– Ready for immediate deployment to a
designated site within the state.
South Carolina Area Health Education Consortium
SNS Program
Delivery and Transport
• Push packages can be delivered within 12
hours of a federal decision to deploy.
– Authority for material will transfer upon
arrival
• Once package is on the tarmac,
responsibility shifts from federal to local
authorities
• SNS technical advisory response unit
(TARU) staff will arrive and remain
– Coordinate with state and local officials for
efficient delivery and distribution
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SNS: Follow up
• Vendor managed inventory (VMI)
supplies
– Shipped to arrive within 24 to 36 hours.
– Can be tailored to the suspected or
confirmed agent(s).
– Could act as the first option for
immediate response from the SNS if
agent is known.
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Chempacks
• Will be placed in preselected areas within
the state and contain:
– MARK-1 autoinjectors
• 2mg atropine & 600mg 2-PAM
– Bulk atropine sulfate
– Bulk 2-PAM
– Pediatric atropine auto injectors
• 0 .5mg and 1.0mg
– Diazepam (CANA kits)
– Bulk diazepam
– IV fluids and catheters
• To be rolled out in January 2005
South Carolina Area Health Education Consortium
Determining and
Maintaining SNS Assets
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Current biological and/or chemical threats
Availability of medical material
Ease of dissemination of pharmaceuticals
Medical vulnerability of the U.S. Civilian population
• Stock is rotated and kept within potency shelf-life
limits
– Quarterly quality assurance/quality control checks on
all push packages
– Annual 100% inventory of all package items
– Inspections of environmental conditions, security, and
overall package maintenance
South Carolina Area Health Education Consortium
Supplementing State
and Local Resources
• The SNS is not a first response tool
– Significant exposure to nerve agents will
require an antidote within minutes
• During a national emergency, state, local,
and private stocks of medical material will
be depleted quickly
• State and local first responders and health
officials can use the SNS to bolster their
response with a 12-hour push package,
VMI, or both
South Carolina Area Health Education Consortium
When and How is the
SNS Deployed?
• Overt:
– overt release of an agent that might adversely
affect public health.
• Covert:
– subtle indicators, such as unusual morbidity
and/or mortality identified through the
nation’s disease outbreak surveillance and
epidemiology network, will alert health
officials to the possibility (and confirmation)
of a biological or chemical incident or a
national emergency.
South Carolina Area Health Education Consortium
Push Package
“Deployment”
• Local emergency management and public health
authorities determine that the demand for
pharmaceuticals will exceed local supply.
• They will notify their respective central offices in
Columbia.
• The Commissioner of DHEC & Director of SC
EMD will advise the governor.
• If appropriate, the governor will request the push
package from CDC or DHS.
• DHS, HHS, CDC, and other federal officials will
evaluate the situation and determine a prompt
course of action.
– Short turn around time expected.
South Carolina Area Health Education Consortium
Push Package
Delivery & Administration
• State and local authorities will
provide security and transport to
local distribution sites
• Local pharmacists will prepare &
dispense the drugs at public
distribution sites according to state
regulations
• Security will be a major concern
South Carolina Area Health Education Consortium
In South Carolina
• The SNS will be delivered to a
pre-selected site(s) in South Carolina
depending on the nature and extent
of the event.
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South Carolina Specifics
• In the State arena
– The State Law Enforcement Division (SC
SLED) has responsibility for Homeland
Security issues.
• In the Federal arena
– FBI has responsibility for Crisis Management
– FEMA has responsibility for Consequence
Management.
• FBI heads the SC Joint Terrorism Task
Force
– Members represent county and local law
enforcement agencies.
South Carolina Area Health Education Consortium
FBI Regional WMD
Coordinators
Midlands Coordinator
SA Roger Stanton
(803) 551-4200
Low Country
Coordinator
SA Lance Coble
(843) 722-9164
Horry/Georgetown
Coordinator
Upstate Coordinator
SA Jeff Long
(843) 449-2266
SA Tony Garcia
(864) 232-3808
Pee Dee Coordinator
SA Jackie Hamelryck
(843) 662-9363
South Carolina Area Health Education Consortium
Principles Of Emergency Response
And Medical Treatment
• Multidisciplinary approach is necessary
– Emergency medical needs
– Emergency public health needs
• Coordination will be required
– First responders
– Law enforcement and security personnel
– Medical personnel and public health
specialists
– Toxicologists and environmental engineers
– Laboratory personnel
South Carolina Area Health Education Consortium
The Pharmacist
as Counterterrorist
• Easily accessible source of information in
the pre-event phase.
• Can provide appropriate reassurance or
accurate information should a disaster or
emergency occur.
• SC Pharmacy Association “Pharmalert
Network"
– Participating pharmacies are hooked into the
DHEC "health alert network".
South Carolina Area Health Education Consortium
Initial Role of the
Pharmacist
• Role used to be dispensing the
medications and supplies to those in the
disaster situation in need of prescription
on a short term basis
• This role became extended to fill orders
for distribution in mass casualty situations
• Role involves not only the initial
distribution of supplies but also the
requirements to ensure a re-supply of
medications.
South Carolina Area Health Education Consortium
Expanded Role
of the Pharmacist
• Bioterrorism preparedness
• Management of pharmaceutical
stockpiles
• Participant in mass vaccination,
prophylaxis and treatment at public
health distribution centers
South Carolina Area Health Education Consortium
Medical Outreach Team
• Composed of physicians, nurses, EMT,
preventive medicine staff and pharmacists
• Drug info / dispensing / distribution
• Patient education
• Non-traditional clinical functions during
an emergency
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Triage and physical assessment
Taking histories to exclude contraindications
Medication administration
Collection of epidemiological data; screening
surveys
South Carolina Area Health Education Consortium
ASHP Statement
Role of Pharmacists in
Counterterrorism
• Key role in planning and execution
of
– Pharmaceutical (Rx) distribution and
control
– Drug therapy management of affected
patients
AJHP 2002;59:282-3.
South Carolina Area Health Education Consortium
Expertise must be sought in:
– Selecting drugs and related supplies for
national and regional stockpiles and local
emergency inventories
– Ensuring proper packaging, storage and
handling, labeling and dispensing of
emergency pharmaceuticals
– Ensuring appropriate deployment of
emergency pharmaceuticals in the event of an
attack
– Developing guidelines for Diagnosis and
treatment of victims of WMD
– Ensuring appropriate education and
counseling of individuals who receive
treatment from an emergency supply after an
event.
South Carolina Area Health Education Consortium
Must be in a position to:
• Advise public health officials on
appropriate messages to convey to
the public about the use of essential
pharmaceuticals after an attack
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Adverse effects
Contraindications
Effectiveness of alternatives
Potential for development of drug
resistance
South Carolina Area Health Education Consortium
Should be called upon to:
• Collaborate with physicians and
other health care prescribers in the
drug management of victims