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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: • • • • • • • • 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: – – – – – – – 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 South Carolina Area Health Education Consortium 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 ! South Carolina Area Health Education Consortium Ciprofloxacin • Anthrax: – Treatment: 400mg IV q8-12h – Prophylaxis: 500mg PO bid x 4 wks; vaccinate • Plague – Prophylaxis: 500mg PO bid x 7 days South Carolina Area Health Education Consortium 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 South Carolina Area Health Education Consortium 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. South Carolina Area Health Education Consortium 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 – – – – 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 South Carolina Area Health Education Consortium 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/ South Carolina Area Health Education Consortium Toxins • Decontamination • Supportive care • Anti-toxin when available – Botulism: depending on serotype • Investigational vaccines: – Botulism South Carolina Area Health Education Consortium 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 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 • • • • • • • • 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 – – – – – – – – – 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 South Carolina Area Health Education Consortium 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. South Carolina Area Health Education Consortium 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 • 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 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. South Carolina Area Health Education Consortium 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 – – – – 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 – – – – 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