Pharmaceutical Response to a Terrorist Attack and Strategic National Stockpile

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Pharmaceutical Responseto a Terrorist Attack
and Strategic National Stockpile
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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
• 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

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Acknowledgment

• This material has been prepared for SC AHEC
  Bioterrorism Training Networkby
• Deborah Stier Carson, PharmD, BCPSProgram
  Manager of SC AHEC Bioterrorism Training Network
• Professor Emerita, College of PharmacyMedical
  University of South Carolina

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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.

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Definition of Bioterrorism Classes

• Bacteria
• Anthrax
• Brucellosis
• Cholera
• Glanders
• Plague
• Tularemia
• Q Fever

• Viruses
• Small Pox
• Venezuelan Equine Encephalitis
• Viral Hemorrhagic Fevers
• Toxins
• 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
• Prophylaxis100mg PO bid x 4 wks vaccinate
• Plague
• Tx 200mg IV then 100mg IV x 10-14 days
• Prophylaxis100mg 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
• Prophylaxis100mg PO bid x 14d

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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.

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Other Antibiotics

• Sulfadiazine
• Glanders
• SMP/TMX
• Glanders
• Streptomycin
• Tularemia
• Plague
• Penicillin / Amoxicillin
• Anthrax

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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.

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Anti-virals

• Viral hemorrhagic fever
• Ribavirin
• Supportive care for victims
• Vaccine investigational
• Universal blood /bodily fluids precautions to
  prevent spread !!
• Smallpox
• Immune globulin chemoprophylaxis
• Vaccination - prevention

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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.

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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

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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

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Contraindications to Smallpox Vaccination

• For vaccinees only
• Previous allergic reaction to smallpox vaccine or
  any of the vaccines components
• Moderate or severe acute illness
• Children under 12 months of age
• Breastfeeding
• Heart disease

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All contraindications to vaccinations will be
reconsidered in a smallpox emergency.
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Current Status ofVoluntary 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.

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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.

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Other Vaccines

• Anthrax
• Multi-dose
• Annual booster
• Limited usefulnessfor preventionin 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)
• Cyanide
• Lewisite blistering agent
• Sulfur mustard blistering agent
• Phosgene pulmonary toxin
• Chlorine pulmonary toxin

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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

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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

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Atropine as an AntidoteValidated 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.
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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.

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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.

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Supportive Carefor 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

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Pills to the PeopleThe Problem with Stockpiling

• Antidotes and treatments are expensive
• Have limited shelf-lives
• Unlikely to be used in large quantities

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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.

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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 nations
  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

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Strategic National Stockpile

• Repository of
• Antibiotics
• Vaccines
• Immunoglobulins
• Chemical antidotes
• Antitoxins
• Life-support medications
• IV administration
• Airway maintenance supplies
• Medical/surgical items

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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

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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.

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SNS ProgramDelivery 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

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Determining and Maintaining SNS Assets

• Factors for considerations
• 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

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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

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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 nations
  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.

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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.

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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

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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.

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FBI Regional WMD Coordinators

• Midlands Coordinator
• SA Roger Stanton
• [phone]
• Horry/Georgetown Coordinator
• SA Jeff Long
• [phone]

• Low Country Coordinator
• SA Lance Coble
• [phone] 
• Upstate Coordinator
• SA Tony Garcia
• [phone] 
• Pee Dee Coordinator
• SA Jackie Hamelryck
• [phone]

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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

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The Pharmacistas 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". 

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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.

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Expanded Role of the Pharmacist

• Bioterrorism preparedness
• Management of pharmaceutical stockpiles
• Participant in mass vaccination, prophylaxis and
  treatment at public health distribution centers

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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
• Triage and physical assessment
• Taking histories to exclude contraindications
• Medication administration
• Collection of epidemiological data screening
  surveys

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ASHP StatementRole of Pharmacists in
Counterterrorism

• Key role in planning and execution of
• Pharmaceutical (Rx) distribution and control
• Drug therapy management of affected patients

AJHP 200259282-3.
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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.

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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
• Adverse effects
• Contraindications
• Effectiveness of alternatives
• Potential for development of drug resistance

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Should be called upon to

• Collaborate with physicians and other health care
  prescribers in the drug management of victims

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