Index

[Page numbers followed by b, f, n, or t refer to boxed text, figures, footnotes, or tables, respectively.]

A

Accountability

importance of, 165, 166

recommendations for, 12, 170, 209-210

Adherence to prophylactic antibiotic regimen

adverse events and, 131

concerns with predispensing strategies, 138

as determinant of prepositioning strategy effectiveness, 181

evidence, 84, 121, 128-130

Adverse events, 75, 130-132, 173

Al Qaeda, 23

Allergic reactions, 75, 132, 142-143

Alliance for Prudent Use of Antibiotics, 132

American Media Inc., 57

American Pharmacists Association, 108

Amoxicillin, 42, 131

Anthrax attack

animal models for studying effects of, 54-55

current state of response readiness, 2-3

danger of, 5, 23-24

data sources for MCM planning, 34-35

historical experience in the United States, 23, 24, 47, 48t, 56-57, 84, 125, 131

lethality, 23, 24-25, 41, 55

potential scenarios, 174-175

public health challenges, 1, 2, 21

See also Antibiotic prophylaxis, post-exposure; Prepositioning of anthrax countermeasures; Risk of anthrax attack

Anthrax vaccine adsorbed, 32, 42

Antibiotic prophylaxis, post-exposure animal studies, 55

approved agents, 5, 42

challenges in responding to aerosolized anthrax attack, 21

constraints on effectiveness of, 5-7

determinants of effectiveness, 13-14, 41



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Index [Page numbers followed by b, f, n, or t Anthrax attack refer to boxed text, figures, footnotes, animal models for studying effects or tables, respectively.] of, 54–55 current state of response readiness, 2–3 A danger of, 5, 23–24 data sources for MCM planning, Accountability 34–35 importance of, 165, 166 historical experience in the United recommendations for, 12, 170, States, 23, 24, 47, 48t, 56–57, 209–210 84, 125, 131 Adherence to prophylactic antibiotic lethality, 23, 24–25, 41, 55 regimen potential scenarios, 174–175 adverse events and, 131 public health challenges, 1, 2, 21 concerns with predispensing See also Antibiotic prophylaxis, strategies, 138 post-exposure; Prepositioning of as determinant of prepositioning anthrax countermeasures; Risk strategy effectiveness, 181 of anthrax attack evidence, 84, 121, 128–130 Anthrax vaccine adsorbed, 32, 42 Adverse events, 75, 130–132, 173 Antibiotic prophylaxis, post-exposure Al Qaeda, 23 animal studies, 55 Allergic reactions, 75, 132, 142–143 approved agents, 5, 42 Alliance for Prudent Use of Antibiotics, challenges in responding to 132 aerosolized anthrax attack, 21 American Media Inc., 57 constraints on effectiveness of, 5–7 American Pharmacists Association, 108 determinants of effectiveness, Amoxicillin, 42, 131 13–14, 41 329

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330 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX emergency use authorization, 86 Assistant Secretary for Preparedness expiration of medications, 85, 88, and Response, 108, 156 114–115, 116 Association of State and Territorial goals for timely distribution, 7, 21, Health Officials, 108 58, 61 Aum Shinrikyo, 23 impact of time to detection on, 57–61 B incubation period of anthrax and, 6–7, 46, 55–57, 61 BioWatch Actionable Result, 59 mechanism of action, 33 BioWatch monitoring system, 35, recommendations for research, 19, 58–60 215 Brentwood postal facility, 56, 84 response to anthrax attacks of Business Executives for National 2001, 56–57 Security, 77 salient issues, 41 storage of medications, 114 C treatment regimen, 42, 133 See also Adherence to prophylactic Cached MCM antibiotic regimen; Antibiotic- advantages, 95–97t resistant anthrax appropriateness and consequences Antibiotic-resistant anthrax of, 15t, 199–202, 200t concerns with predispensing definition, 7, 8f, 29b, 93 strategies, 132–133, 134–135, determinants of effectiveness, 13 136 in educational institutions, creation of, 5, 43, 132–133 118–119 definitions, 43n in hospitals and health care flexibility of MCM system, 45, 46 facilities, 26, 103–106 implications for MCM planning, infrastructure needs, 95–97t 5–6, 32, 43–46 key features, 94, 95–97t laboratory testing for, 44b, 45n organizational entities needed for, threat of, 24, 43, 44b 95–97t Antitoxin strategies, 26, 33 potential health risks, 172 Appropriateness of prepositioning potential locations, 103 strategies, 14, 15t, 199–202, private sector participation, 107 200t recommendations for local Assessment of distribution and jurisdictions, 14–16, 18b, 203, dispensing capacity 211 data from full-scale exercises, role of community- and faith-based 162–163 organizations, 117–118 in decision-aiding framework for See also Home storage of prepositioning, 10b, 154b, antibiotics; Personal stockpile; 158–163 Workplace caches importance of, 10, 163 Centers for Disease Control and measures for, 10, 11, 25, 159–161, Prevention 164, 212 Cities Readiness Initiative, 7, 53b, obstacles to, 10–11, 158, 163 58, 61, 73 recommendations for, 11, 164, 212

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331 INDEX classification of anthrax as Community health centers, 105–106 bioterrorism agent, 24 Community organizations, 117–118 Countermeasure Inventory Tracking Consequences of anthrax attack, as program, 108 risk assessment component, 155, in development of guidance on 156 public–private coordination, 110 Costs measures of state and local annual inventory maintenance, dispensing capacity, 25, 159–160 193–194 postexposure antibiotic regimen components of, in prepositioning, recommended by, 42 173, 191–193 Public Health Emergency consideration of, in decision-aiding Preparedness Cooperative framework, 10b, 154b, 173 Agreement, 105, 161, 162–163 to dispense MCM, 194–195 recommendations for, 11, 164, 212 ethical decision making in public support for full-scale exercises, health, 166 162–163 evaluation of prepositioning See also Strategic National Stockpile strategies, 13, 173 CHEMPACK Program, 71n, 100–101, expiration of medications, 88, 102 100b FDA-approved MedKit Children development, 141–142, 195–197, anthrax postexposure treatment 199 regimen, 42 forward deployment by Strategic consideration of, in public health National Stockpile, 99–100 planning, 34, 167 full-scale distribution and dispensing dosing concerns with predispensed exercises, 162 antibiotics, 135 initial stocking, 193 risk of unintended ingestion of multidrug strategies, 135 antibiotics, 133 recommendations for evaluation of, Ciprofloxacin, 5, 42, 88, 114, 131 13, 202–203, 210–211 Cities Readiness Initiative, 7, 53b, 58, recommendations for research on, 61, 73 19, 214–215 Communications See also Health benefits and challenges in predispensing economic costs of prepositioning strategies, 136–138 Countermeasure Inventory Tracking importance of, 83, 136 program, 108 instructions for use of predispensed Critical infrastructure personnel medications, 137 definition, 28b POD information, 85, 104 Executive Order on, 33 for push strategy implementation, 78 need for special consideration of, recommendations for research, 19, 197 215 predispensed MCM for, 139–142, SNS: Supply Chain Dashboard for, 198–199 108 prepositioning strategies for, 198 strategic planning for MCM risk of inappropriate use of dispensing, 83–84 predispensed antibiotics, 141 Community Emergency Response Cutaneous anthrax, 41, 60 Teams, 118

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332 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX D Disposal of antibiotics, 133–134, 193 Distribution and dispensing system Data sources for MCM planning capacity assessment, 10–11, 25, 35, animal studies, 54–55 158–163 anthrax incubation period, 46–47 current concerns and shortcomings, current limitations, 34–35 2–3, 24–25, 36, 82–85, 89 drills and exercises, 162–163 current goals, 7, 21, 58, 61 ethical obligations to improve, 165 current structure, 69–71, 88–89 from H1N1 influenza pandemic determinants of effectiveness of, response, 163 187–199 Department of Defense, 26 implications of antibiotic-resistant forward deployment of MCM at anthrax, 44–45 facilities of, 101 local dispensing capability as Department of Health and Human rate-limiting factor in attack Services, 26 response, 187–188 in emergency response system, 72, need for national guidance on 86, 87, 108 public–private coordination, recommendations for, 9, 19, 112, 109–111, 111b 211, 214–215 private sector participation, 9, 107, Department of Homeland Security, 5, 108–109 24, 26, 155, 156, 163 public behavior as determinant of BioWatch monitoring system, 35, effectiveness of, 181, 188, 58–60 214t Department of Justice, 26 recommendations for local Detection and surveillance system jurisdictions to improve, 14–16, capabilities assessment, in decision- 18b, 203, 211 aiding framework, 10b, 154b, recommendations for national 157 guidance on public–private case reports in, 60–61 coordination, 9, 18b, 112, 211 as component of national security response to H1N1 influenza strategy, 26 pandemic, 25 cutaneous disease, 60 role of clinicians and first as determinant of dispensing system responders, 81 effectiveness, 187 strategies for, 7. See also specific environmental sensors, 58–60 strategy impact on post-exposure terminology, 28b prophylaxis, 57, 62 See also Medical countermeasures implications for dispensing (MCM) for inhalational anthrax; decisions, 35, 85 Prepositioning of anthrax mechanisms, 58 countermeasures; Time from prophylaxis distribution and, 7 release to dispensing recommendations for capability Distribution curve of incubation assessment, 12, 18b, 202–203, period, 6, 46 210–211 Distributive justice, 12, 165, 166, 170, role of clinicians and first 209–210 responders, 81 Dose effects in anthrax exposure, Diethylene triamine pentaacetic acid, 51–52 101

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333 INDEX F Dosing concerns with predispensed antibiotics, 135 Faith-based organizations, 118 Doxycycline False alarms, 16 adverse event risk, 131 Federal Food, Drug, and Cosmetic Act, allergic reactions, 132 86 anthrax post-exposure prophylaxis, Federal government 5, 42 mission-essential personnel, 33 concerns about antibiotic-resistant need for national guidance on anthrax, 43–44, 45 public–private coordination, emergency use authorization, 86 109–111, 111b shelf life, 88 as provider of threat information, storage requirements, 114 155–156 Drills and exercises recommendations for, 2, 18b, 36, data from, 10–11, 25, 162–163 164, 212 head-of-household dispensing See also specific agency or model, 75–77 department push strategy, 78 First-order model, 175–180, 237–240 recommendations for, 11, 164, 212 First responders See also Postal model of anthrax vaccination for, 32 distribution, pilot program; St. in current distribution and Louis, Missouri, pilot study dispensing system, 81 definition, 28b, 33–34 ethical obligations of communities E to, 166 Emergency use authorization, 72, MedKits for, 139 86–87, 114 need for special consideration of, approval process, 79n, 86 197 definition, 28b predispensed MCM for, 139–142, MedKit, 29b, 87, 119, 139, 142, 198–199 144t, 195–196 prepositioning strategies for, 198 for Postal Model pilot program, 79, recommendations for prepositioning 87, 139 strategies, 16, 203, 211 Environmental Protection Agency, risk of inappropriate use of 165–166 predispensed antibiotics, 141 Ethical principles and issues, 11–12, Flexibility of distribution and 18b, 154b, 164–170, 198, 203, dispensing systems 209–210, 211 concerns with predispensing Ethnic/racial groups, 34, 158, 166 strategies, 134–136, 198 Expiration of medications, 85 to respond to drug-resistant implications for predispensing anthrax, 45, 46, 136, 141 strategies, 88, 138 Food and Drug Administration state-owned stockpiles, 102 emergency use authorization, 28b, workplace caching and, 114–115, 72, 79n, 86–87, 114 116 MedKit approval, 17, 119, 139, See also Shelf Life Extension 141–142, 144t, 195–197, 199, Program 203

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334 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX prescription laws, 86 evaluation of potential recommendations for, 17, 203 prepositioning strategies, 10b, shelf life extensions, 88 154b Forum on Medical and Public Health findings from cost–benefit modeling, Preparedness for Catastrophic 186–202 Events, 83 incorporation of ethical principles Forward-deployed MCM and community values, 10b, advantages, 95t 154b, 164–170 appropriateness and consequences key elements, 9, 10b, 153, 154b of, 15t, 199–202, 200t need for, 108–109 by commercial entities, 102–103 purpose, 2, 9, 35–36, 153 definition, 7, 8f, 29b, 93 recommendations for research to at Department of Defense facilities, support, 19, 212–215 101 Fukushima, Japan nuclear accident, determinants of effectiveness, 13 120, 125–126, 128–129 dispensing capacity, inventory levels and, 102 G examples, 95t impact on response time, 99 Gastrointestinal anthrax, 41 infrastructure needs, 95t Georgia, 77 key features, 94, 95t Good manufacturing practice for organizational entities needed for, pharmaceuticals, 86 95t potential health risks, 172 H recommendations for local jurisdictions, 14–16, 18b, 203, H1N1 influenza pandemic, 3, 25, 71, 211 103, 108, 113, 163 state control of, 73, 101–102 Hamilton, New Jersey, postal facility, by Strategic National Stockpile, 56 99–101 Hazard Vulnerability Analysis, 156 at Veterans Administration Head-of-household dispensing model, hospitals, 101 75–77, 82, 138 Framework for decision making Health benefits and economic costs of assessment of anthrax attack risk, prepositioning 10b, 154–157 evaluation in decision-aiding assessment of attack detection framework, 10b, 154b, 171 capabilities, 10b, 154b, 157 findings from cost–benefit modeling, assessment of current dispensing 191–199 capabilities, 10b, 154b, modeling methodology, 174–186, 158–163 237–240 cost–benefit modeling, 174–186 recommendations for evaluation of, evaluation of likely economic costs, 13, 171, 202–203, 210–211 10b, 154b, 173 Health care providers evaluation of potential health in closed workplace PODs, 114, benefits, 10b, 154b, 172–173 115–116

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335 INDEX MCM caching in nonhospital health MCM caching in, 26, 103–105 care facilities, 106 as PODs, 104 rationale for MCM caching in potential effectiveness of closed health care settings, 103, 104 PODs, 188–191 recommendations for prepositioning strategies, 16, 203, 211 I High-risk jurisdictions determinants of risk, 155 Inappropriate use forward deployment of MCM to, estimated prevalence, 128–130 99, 101 form of predispensing and, 130 recommendations for assessment of medication use instructions and, capabilities, 11, 164, 212 137 value of prepositioning strategies in, risk among first responders and 14, 197, 202 critical infrastructure personnel, Home storage of antibiotics 141 in continuum of prepositioning risk in predispensed MCM, 2, 16, strategies, 7 121, 128, 172–173 cost–benefit modeling of risk of antibiotic resistance in, prepositioning strategies, 175, 132–133 181 Incubation period of anthrax cost comparison of prepositioning animal studies, 54–55, 61 strategies, 195 cutaneous disease, 60 creation of multi-drug-resistant data sources, 6, 7, 34–35, 46–47, anthrax and, 6, 45–46, 132–133 61 expiration of medications, 88 distribution curve, 6, 46 initial costs, 193 dose effects, 51–52 maintenance costs, 193–194 historical evidence, 47–52, 61–62 recommendations, 2 implications for distribution and responsibilities of local jurisdictions, dispensing strategies, 6–7, 46, 138–139 55–57, 61 storage and disposal issues, minimum, 46, 61 133–134 theoretical modeling, 52, 53–54b See also Predispensed MCM Insurance coverage, MedKit, 196 Hospital Preparedness Program, Investigational Device Exemption, 72 104–105, 156 Investigational New Drug, 72, 121 Hospitals and acute care facilities Israel, 120 cost–benefit modeling of prepositioning strategies, 175, J 181 cost comparison of prepositioning Joint Commission, 104 strategies, 195 costs of MCM inventory maintenance, 193–194 L costs to dispense MCM from, Legal issues 194–195 emergency use authorizations, initial costs to stock MCM, 193 86–87

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336 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX liability protection in emergencies, emergency use authorization, 29b, 86, 87, 109, 114, 116–117 119, 139, 144t, 195–196 in predispensing strategies, 139 expiration of medications, 88 prescription laws, 86 FDA-approved, 8f, 17, 29, 119, preservation of civil rights in 139, 141–142, 144t, 195–197, emergency responding, 166–167 199, 203–204, 212 for private sector closed PODs, instructions for use, 137 115–117 legal issues, 139 scope of, 85 over-the-counter, 119–120 workplace caching, 114 pharmaceutical development costs, Levofloxacin, 5, 42 196–197 pilot studies, 79, 121–124, 129–130 recommendations, 17, 18b, 203– M 204, 212 replacement costs, 193 Material Threat Determination, 5, 43, risk of inappropriate use of 44b, 155 contents, 129–130 MCM. See Medical countermeasures storage and disposal issues, 133, 134 for inhalational anthrax Memoranda of understanding/ Meals on Wheels, 117 agreement, 110, 113–114 Medical countermeasures (MCM) for Metropolitan statistical areas, 73 inhalational anthrax Minneapolis–St. Paul, Minnesota, antitoxin administration, 33 79–80, 120, 123–124, 129–130, categories of strategies for, 7. See 139, 141 also specific strategy Minnesota. See Minneapolis–St. Paul, current plans, 1, 3, 24–25, 69–71, Minnesota 88–89 Mission-essential personnel, 33 definition of MCM, 28b Missouri. See St. Louis, Missouri, pilot generalizability of findings from study research on, 30–32 Model Pharmacy Act, 114n private sector role, 3, 9, 107 public engagement in planning for, 12, 167–168, 170, 209–210 N schematic of strategies for, 31f vaccination, 32 National Alliance of State Pharmacy See also Distribution and dispensing Association, 108 system; Predispensed MCM; National Association of Chain Drug Prepositioning of anthrax Stores, 108 countermeasures National Association of County and Medical/nonmedical points of City Health Officials, 108 dispensing, 75 National Bioterrorism Hospital MedKit Preparedness Program, 104n antibiotic supply in, 137 National Community Pharmacists cost, 193 Association, 108 definition, 8f, 29b National Voluntary Organizations disposal options, 193–194 Active in Disaster, 117 Natural disasters, 25

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337 INDEX Nerve agent antidote program, closed, 71, 75, 77, 109, 112–113 100–101, 100b, 120 costs to dispense MCM, 194–195 current concerns about plans and New Tools for Assessing State capabilities, 82–83, 85 and Local Capabilities for Countermeasure Delivery, 161 current distribution and dispensing New York state, 101–102 plans, 1, 3, 71, 73–74, 88–89 definition, 14, 28–29b determinants of effectiveness, 74 O drive-through, 74 head-of-household model, 75–77 Oseltamivir, 196 hospitals and acute care facilities as, 104 P medical/nonmedical, 75 nonhospital health care facilities as, Packaging 106 FDA-approved MedKit, 196 open, 73–74 predispensed MCM, 17, 130 potential effectiveness of Pandemic and All-Hazards prepositioning strategies, Preparedness Act, 104n 188–191 Penicillin G, 5, 42, 131 private sector agreements with Personal stockpile jurisdictions, 110 definition, 8f, 29b private sector locations, 109 indications for, 198 processing time, 85 individual purchase of, 198 rationale for forward deployment of legality, 139 MCM, 99 misuse concerns, 130, 137, 144t retail pharmacies as, 107 recommendations, 16, 203 security concerns, 82 storage and disposal issues, 134 sites for, 74–75, 85, 101 See also Home storage of staffing, 74, 75, 83 antibiotics; MedKit time needed to make ready, 99 Pharmaceutical Research and transportation considerations in Manufacturers of America, 108 selection of, 85 Pharmacies See also Workplace caches in coordinated response to H1N1 Postal model of distribution, 3, 74 influenza pandemic, 108 advantages, 79 MCM caching in, 106–107 in current distribution and need for framework for dispensing plans, 71 collaboration with government Executive Order on, 26, 80 in response to anthrax attack, follow-up monitoring of kits, 88 108–109 goals, 79 as POD sites, 74–75, 107 legal liability protections in, 87 private sector role in forward obstacles to implementation, deployment of MCM, 102–103 80–81 Philadelphia drill, 75, 82 pilot program, 26, 43–44, 79–80, POD. See Points of dispensing 88, 120, 123–124, 129–130, Points of dispensing (PODs) 135, 139, 141 benefits of prepositioning, 14

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338 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX predispensed MCM for families of risk of adverse drug events, postal workers, 140 130–132 rationale, 78–79 risk of antibiotic resistance from security issues in, 80–81 misuse of, 132–133 Postal system, anthrax attacks of 2001, risk of unintended ingestion, 133 23, 47, 56–57, 84 scope of concerns about, 127–128 Potassium iodide, predispensing of, screening for contraindications to 120, 124–127, 124b use, 135–136 Predispensed MCM special challenges in, 119 adherence issues, 84, 138 special packaging for, 17, 130 advantages, 97–98t state and local responsibilities, appropriateness and consequences 138–139 of, 15t, 199–202, 200t storage, 114, 133 communications challenges, to targeted populations, 14–16, 136–138 16, 17, 33–34, 139–143, 197, comparison of different forms of, 198–199, 203 143, 144t See also Home storage of antibiotics in continuum of prepositioning Pregnancy, 135 strategies, 7, 119 PREP Act Declaration, 87 costs, 197 Prepositioning of anthrax definition, 8f, 94, 119 countermeasures determinants of risk associated annual maintenance costs, 193–194 with, 127 categories of strategies for, 7, 36, dosing concerns, 135 93–94, 95–98t, 170–171. See evaluation of risk associated with, also specific strategy 127 comparison of appropriateness and expiration of medications, 138 consequences of strategies, 15t, flexibility concerns, 134–136 199–202, 200t forms of, 7, 119–120 as component of national security to general public, 14, 16, 120, 126, strategy, 3, 26, 215 127–128, 130, 134, 136 concerns about negative historical experience, 120–127 consequences, 2, 3, 14, 93 inappropriate use risk, 16, 17, 121, continuum of strategies, 7, 27, 29b 128–130, 172–173 cost components, 191–192 infrastructure needs, 97–98t, cost evaluation, 13, 173 138–139 cost to dispense, 194–195 key features, 94, 97–98t definition, 1, 3, 29b legal issues, 139 ethical issues, 168–170 for patients with special medical expiration of medications, 88 needs, 142–143 findings from cost–benefit modeling, multidrug model, 135 188–202 organizational entities needed for, health risks, 2, 172–173 97–98t implications of multi-drug-resistant public understanding of proper use agents, 5–6, 43–46 of, 137 initial stocking costs, 193 recommendations for, 14–16, 203, issues of concern, 262 211

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339 INDEX legal issues, 86–87 legal issues in MCM distribution need for national guidance on and dispensing, 87, 115–117 public–private coordination, in MCM caching, 107 109–111 in MCM development and delivery, potential effectiveness of strategies, 3, 26, 77, 107, 108–109 188–191 need for framework for potential limitations to effectiveness collaboration with government of, 2, 14, 172 in response to anthrax attack, public behavior as determinant of 108–109 effectiveness of, 137–138, 188 need for national guidance on rationale, 1, 3, 13–14, 26, 93, 171, public–private coordination, 172 109–111, 111b recommendations for evaluation obstacles to participation in of strategies for, 12–13, 18b, distribution and dispensing 202–203, 210–211 system, 9, 107, 109–110, 112 recommendations for integration obstacles to successful collaboration of ethical principles and public with government, 77, 117 engagement in, 11–12, 18b, 170, potential POD sites, 74, 77, 109 209–210 recommendations for national recommendations for national guidance on public–private guidance on public–private coordination, 9, 18b, 112, 211 coordination, 9, 18b, 112, 211 state push strategy experiment, 78 recommendations for research to understandings and agreements with inform decision making on, 18b, jurisdictions, 110, 117 19, 212–215 See also Pharmacies; Workplace recommendations from cost–benefit caches modeling, 202–204 Public, defined, 29b, 33 resource demands, 2, 191–193, 197 Public health risk-related information for, challenges in responding to 156–157 aerosolized anthrax attack, 1, 2, strategies for, definition and scope 21 of, 29b, 171 ethical framework for MCM study goals, 4, 21–22 planning, 11–12, 164–170, study process, 4–5, 22–23, 27 209–210 See also Framework for decision recommendations for local making; Recommendations jurisdictions to improve Presidential Executive Orders, 26, 33, dispensing capabilities, 14–16, 80 18b, 203, 211 Private sector Public Health Emergency Preparedness arrangements with local Cooperative Agreement, 105, jurisdictions for distribution and 161, 162–163 dispensing, 110 Public Health Law Network, 115 collaboration in response to H1N1 Public Health Preparedness influenza pandemic, 108 Capabilities, 159–160 in forward deployment of MCM, Public Health Preparedness 102–103 Capabilities, 25

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340 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Public knowledge and understanding rationale for forward deployment of adherence to prophylactic antibiotic MCM, 99 regimen, 84 time needed to make ready for concerns about antibiotic-resistant distribution, 99 anthrax, 44b Reciprocal obligations, 12, 165, 166, of dispensing system, 85, 104 170, 209–210 dosing concerns with predispensed Recommendations antibiotics, 135 against development of FDA- participation in MCM planning, 12, approved MedKit, 17, 18b, 212 165, 167–168, 170, 209–210 for assessment of distribution and for predispensing strategies, dispensing systems, 11, 164, 212 136–137 for evaluation and development of role of clinicians and first prepositioning strategies, 12–13, responders in MCM system, 81 18b, 202–203, 210–211 strategic planning for MCM for federal government, 9, 11, 17, dispensing, 83–84 18b, 19, 112, 164, 204, 211, use of MCM in response to 212, 214, 215 perceived threat, 125–127, for integration of ethical principles 128–129, 137 in prepositioning strategies, Public Readiness and Emergency 11–12, 18b, 170, 209–210 Preparedness Act, 85, 86, 87, for large-scale exercises, 11, 164, 212 110, 114, 116–117 for national guidance on public– Pull strategies, 73–74 private coordination, 9, 18b, Push Packages, 43, 72, 88, 159 112, 211 Push strategies for public engagement in MCM advantages, 78 planning, 12, 18b, 170, 209–210 definition, 73–74, 78 for research to inform MCM disadvantages, 78 decision making, 18b, 19, recommendations, 14, 203 212–215, 213–214t, 215b state experiments, 78 Red Cross, 117 See also Points of dispensing Regional distribution centers, 71 (PODs), closed; Postal model of Research needs, to inform decision distribution making about prepositioning strategies, 18b, 19, 212–215, 213–214t, 215b Q Risk of anthrax attack assessment of, for decision-aiding Q-fever, 52, 54b framework, 154–157 Quarantines, 168 components of risk, 155 Department of Homeland Security R assessments, 156 high-risk jurisdictions, 11, 14, 99, RAND-CDC Performance Metrics 101 Project, 161 implications for prepositioning Receiving, staging and storage centers strategies, 156–157, 186 in current distribution and recommendations for assessment of, dispensing system, 71, 72 12, 18b, 202–203, 210–211

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341 INDEX S local dispensing capability as rate-limiting factor in attack Schools, cached MCM in, 118–119 response, 187–188 Security issues recommendations for, in closed workplace PODs, 114 development of national concerns about current dispensing guidance for public–private system, 82 coordination, 9, 112, 211 in postal model of distribution, recommendations for assessment 80–81 of MCM planning and Shelf life. See Expiration of implementation, 11, 164, 212 medications recommendations for evaluation of Shelf Life Extension Program, 85, 88, prepositioning strategies, 12–13, 99, 101, 102 18b, 202–203, 210–211 Skilled nursing facilities, 105–106 recommendations for improving SNS: Supply Chain Dashboard, 108 dispensing capabilities, 14–16, Socioeconomic status, access to MCM 18b, 203, 211 and, 34, 117–118, 158, 166, 169 recommendations for integration Special need patients, 142–143 of ethical principles in MCM St. Louis, Missouri, pilot study, 120, planning, 11–12, 18b, 170, 121–123, 129–130, 133, 137, 209–210 141 regional distribution centers, 71 Staffing responsibilities in predispensing clinicians and first responders in strategies, 138–139 distribution and dispensing state control of forward-deployed system, 81 MCM, 101–102 concerns about current dispensing variations among, effectiveness of system, 83 prepositioning and, 14, 35, 153, points of dispensing, 74, 75, 83 154b, 197 role of medical professionals in State Homeland Security Program, 156 closed workplace PODs, 114, State Mitigation Plan, 156 115–116 Stewardship, 12, 165, 166, 170, Stafford Act, 110 209–210 State, local, and tribal jurisdictions Storage of medications, 114, 133 arrangements for private sector Strategic National Stockpile collaboration in distribution and anthrax antitoxin stockpile, 33 dispensing, 110 assessing time to delivery from, 159 assessment of distribution and CHEMPACK Program, 100–101, dispensing capabilities, 10–11, 100b 35, 82 contents, 43, 45, 71–72 current MCM plans for anthrax, 3, in current MCM plans, 1, 3, 7, 24, 73–74, 88–89 69–72, 88–89 decision making on prepositioning definition, 30b, 71 strategies. See Framework for forward deployment of MCM by, decision making 99–101 legal issues for private sector PODs, process for withdrawals from, 72 115–116 recent deployments, 71

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342 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX recommendations for assessment of Strategic National Stockpile delivery capabilities, 11, 164, 212 time, 159 response to antibiotic-resistant Transparency anthrax attack, 45 importance of, 165, 166 stock rotation and replacement recommendations for, 12, 170, program, 88 209–210 Technical Assistance Review, 25, Transportation issues, 85, 158 160 Tularemia, 52, 54b warehouse locations, 99 Sverdlovsk incident, 7, 23, 34–35, 43, U 49–52, 53b, 54b, 61 UPS, 78 Urban Areas Security Initiative, 99, T 156 Technical Assistance Review, 25, 160 Threat and Hazard Identification and V Risk Assessment, 156 Tier 1 cities, 99, 156, 159 Vaccine, anthrax, 26, 32, 42 Tier 2 cities, 156 Vendor-managed inventory, 72, 159 Time from release to dispensing Veterans Administration hospitals, 101 assessment of detection capabilities, Virginia, 78, 103 157 Vulnerability of jurisdictions, benefits of prepositioning, 3, 13–14, assessment of, 155, 156 93, 172, 202 Vulnerable and at-risk populations data sources for MCM planning, assessment of distribution and 35, 127 dispensing system capability, 158 detection technology and, 35, ethical obligations in prepositioning 58–61, 85 planning, 166, 169–170 establishment of POD sites, 99 predispensed MCM for, 139–140, forward deployment of MCM and, 198–199 99 role of community organizations in impact of time to detection, 57, 61, MCM dispensing, 117–118 62 types of, 34 importance of timely decision making, 13–14, 61, 187, 188 modeling of prepositioning W strategies, 176–181, 187, 237–240 Washington State exercise, 75–77 POD processing time, 85 Workplace caches, 1, 2, 3, 22, 29, 73, potential effectiveness of 74, 107 prepositioning strategies in advantages, 112–113, 198 reducing, 188–191 antiviral stockpiles, 113 predispensed MCM risk assessment, cost–benefit modeling of 127 prepositioning strategies, 175, stages, 57 181

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343 INDEX cost comparison of prepositioning medication shelf life issues, 114– strategies, 195 115, 116 costs to dispense MCM, 195 potential effectiveness, 188–191 current implementation, 113 public seizure of, 117 for first responders and critical role of medical professionals in infrastructure personnel, 140 operations of, 114, 115–116 initial stocking costs, 193 security concerns, 114 legal issues, 115–117 storage space, 114 logistical arrangements, 113–115 supply sources, 112 maintenance costs, 193–194

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