South Carolina Area Health Education Consortium Pharmaceutical Response to a Terrorist Attack and Strategic National Stockpile

South Carolina Area Health Education Consortium

Pharmaceutical Pharmaceutical ResponseResponse

to a Terrorist Attack to a Terrorist Attack and and

Strategic National Strategic National StockpileStockpile


AcknowledgementsAcknowledgements• 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


AcknowledgmentAcknowledgment

This material has been prepared for SC AHEC Bioterrorism Training Network

by

Deborah Stier Carson, PharmD, BCPSProgram Manager of SC AHEC Bioterrorism Training Network

Professor Emerita, College of PharmacyMedical University of South Carolina


ObjectivesObjectives

• 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.


Definition of Definition of Bioterrorism ClassesBioterrorism 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


Antibiotics to Antibiotics to Counteract Biologic Counteract Biologic

WeaponsWeapons• 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 !


CiprofloxacinCiprofloxacin

• Anthrax: – Treatment: 400mg IV q8-12h – Prophylaxis: 500mg PO bid x 4 wks;

vaccinate

• Plague– Prophylaxis: 500mg PO bid x 7 days


DoxycyclineDoxycycline

• 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


Drug Use In PregnancyDrug 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


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.


ContraindicationsContraindications

• ALL contraindications need to be reassessed in the event of a bioterrorism event.


Other AntibioticsOther Antibiotics

• Sulfadiazine– Glanders

• SMP/TMX– Glanders

• Streptomycin– Tularemia– Plague

• Penicillin / Amoxicillin– Anthrax


Emergency Use of Emergency Use of Bleach in Anthrax Bleach in Anthrax DecontaminationDecontamination

• 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.


Anti-viralsAnti-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


Smallpox VaccinationSmallpox 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.


Smallpox VaccinationSmallpox 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


Smallpox Smallpox Vaccination 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


Contraindications to Contraindications to Smallpox VaccinationSmallpox 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


Contraindications to Contraindications to Smallpox VaccinationSmallpox 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


All contraindicationsAll contraindications to vaccinations will be to vaccinations will be

reconsidered reconsidered in a smallpox in a smallpox emergency.emergency.


Current Status ofCurrent Status ofVoluntary Vaccination Voluntary Vaccination

ProgramProgram• 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.


Vaccination Concerns Vaccination Concerns for Healthcare Providersfor 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.


Other Other VaccinesVaccines

• Anthrax– Multi-dose– Annual booster– Limited usefulness

for preventionin general population

• Numerous vaccines being investigated• CDC: National Immunization Program

– Good site for information– http://www.cdc.gov/nip/


ToxinsToxins

• Decontamination

• Supportive care

• Anti-toxin when available– Botulism: depending on serotype

• Investigational vaccines:– Botulism


Chemical AgentsChemical 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


AntidotesAntidotes• 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


““Military Grade” Military Grade” Organophosphate Organophosphate

PoisoningPoisoning• 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


Atropine as an AntidoteAtropine as an AntidoteValidated rapid reformulation from bulk Validated rapid reformulation from bulk

powderpowder

• 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.


Cyanide AntidoteCyanide 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.


Antidote for LewisiteAntidote 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.


Supportive CareSupportive Carefor Chemical Agent for Chemical Agent

ExposureExposure• 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


““Pills to the People”Pills to the People”The Problem with The Problem with

StockpilingStockpiling• Antidotes and treatments are

expensive

• Have limited shelf-lives

• Unlikely to be used in large quantities


Terrorism or Terrorism or Large Scale Natural Large Scale Natural

DisasterDisaster• 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.



(Homeland security act of (Homeland security act of 2002)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



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


SNS: Push SNS: Push PackagesPackages

• 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


SNS: SNS: Fast and FlexibleFast 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.


SNS ProgramSNS ProgramDelivery and TransportDelivery 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


SNS: Follow upSNS: 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.


ChempacksChempacks• 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


Determining and Determining and Maintaining SNS AssetsMaintaining 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


Supplementing State Supplementing State and Local Resourcesand 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


When and How is the When and How is the SNS Deployed?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.


Push Package Push Package “Deployment”“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.


Push Package Push Package Delivery & Delivery &

AdministrationAdministration• 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


In South CarolinaIn 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.


South Carolina SpecificsSouth 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.


FBI Regional WMD FBI Regional WMD CoordinatorsCoordinators

Midlands CoordinatorSA Roger Stanton

(803) 551-4200

Horry/Georgetown CoordinatorSA Jeff Long

(843) 449-2266

Low Country Coordinator

SA Lance Coble

(843) 722-9164 Upstate Coordinator

SA Tony Garcia

(864) 232-3808 Pee Dee Coordinator

SA Jackie Hamelryck(843) 662-9363


Principles Of Emergency Principles Of Emergency Response Response

And Medical TreatmentAnd 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


The PharmacistThe Pharmacistas Counterterroristas 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".


Initial Role of the Initial Role of the PharmacistPharmacist

• 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.


Expanded Role Expanded Role of the Pharmacistof the Pharmacist

• Bioterrorism preparedness

• Management of pharmaceutical stockpiles

• Participant in mass vaccination, prophylaxis and treatment at public health distribution centers


Medical Outreach TeamMedical 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


ASHP StatementASHP StatementRole of Pharmacists in Role of Pharmacists in

CounterterrorismCounterterrorism

• Key role in planning and execution of – Pharmaceutical (Rx) distribution and

control– Drug therapy management of affected

patients

AJHP 2002;59:282-3.


Expertise must be Expertise must be sought in: 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.


Must be in a position to: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


Should be called upon Should be called upon to:to:

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

Documents

South Carolina Area Health Education Consortium Pharmaceutical Response to a Terrorist Attack and Strategic National Stockpile