Pharmaceutical Response Planning for Public Health Emergencies Edbert Hsu, MD, MPH Johns Hopkins Office of Critical Event Preparedness and Response

1
Pharmaceutical Response Planning for Public
Health EmergenciesEdbert Hsu, MD, MPHJohns
Hopkins Office of Critical Event Preparedness
and Response

• This presentation is based on research conducted
  by the Johns Hopkins Office of CEPAR and partner
  agencies sponsored by the Maryland HRSA BHPP
  Program

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Partner Agencies

• Department of Health and Mental Hygiene (DHMH)
• Maryland Board of Pharmacy
• Baltimore City Health Department (BCHD)

• Maryland Emergency Management Agency (MEMA)
• Maryland Institute for Emergency Medical Systems
  Services (MIEMSS)
• Maryland Society of Health System Pharmacists
  (MSHP)

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Background

• CDCs Strategic National Stockpile (SNS) Program
  was developed in 1999 to assist states and
  communities in responding to public health
  emergencies

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Background

• Push packages (12), strategically located are
  scheduled to arrive within 12 hours of decision
  to deploy providing a broad spectrum of assets
• Vendor managed inventory can follow within 24-36
  hours when a specific threat is identified

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Purpose of SNS

• Designed to supplement state and local public
  health agencies in the event of a biological or
  chemical terrorism incident
• Not considered a first response tool

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Issue

• Critical need for preparation on the part of
  state and local planners
• Hospitals must be prepared for immediate response

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Major Project Goals

• Assessment of existing regional hospital
  pharmaceutical supplies
• Establishment of guidelines for developing and
  maintaining optimal pharmaceutical cache at each
  hospital
• Planning for a regional pharmaceutical stockpile

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Pharmaceutical Response Survey

• Developed collaboratively with pharmacists and
  partner agencies
• Piloted with hospital pharmacists
• Phase I administered to all Region 3 hospital
  pharmacists
• Phase II conducted statewide

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Pharmaceutical Response Survey

• Hospital characteristics
• Determination of regional hospital pharmaceutical
  response preparedness
• - specific protocols and written
• agreements
• - access to emergency supply systems
• - delineated plans for coordination with
• SNS assets and prior exercises

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Pharmaceutical Response Survey

• Determination of hospital pharmaceutical response
  capacity for given biological, chemical and
  radiological scenarios
• Cataloguing of pharmaceutical supplies by
  quantity and type

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Key Findings

• Strong participation from hospitals and
  pharmacists surveyed
• A total of 36/45 hospitals throughout the state
  completed the survey
• 80 response rate

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Key Findings

• Has your facility/ system assessed its
  pharmaceutical inventory to determine whether it
  could support the treatment and prophylaxis for
  patients exposed to biological agents?
• Yes (33) 92
• No (2) 6
• Dont Know (1) 3

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Key Findings

• Does your facility have any written agreements or
  memoranda of understanding (MOUs) for pooling or
  obtaining pharmaceutical and medical supplies?
• Yes (26) 72
• No (6) 17
• Dont Know (4) 11

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Key Findings

• Has your facility/ system identified an emergency
  pharmaceutical supply system via pharmaceutical
  vendors related to the prophylaxis and treatment
  for exposure to biological agents?
• Yes (14) 39
• No (22) 61
• Dont Know (0) 0

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Ciprofloxacin 500 mg Tablets
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Ciprofloxacin 500 mg Tablets
17
Doxycycline 100 mg Capsules
18
Doxycycline 100 mg Capsules
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Cyanide Antidote Kits
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Cyanide Antidote Kits
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Key Findings

• Would specific guidelines on maintaining optimal
  hospital pharmaceutical cache be useful in your
  facilitys preparedness planning?
• Yes (32) 89
• No (0) 0
• Dont Know (4) 11

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Key Findings

• Would emergency access to a local or regional
  reserve pharmaceutical stockpile be useful in
  your facilitys preparedness planning?
• Yes (35) 97
• No (0) 0
• Dont Know (1) 3

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Key Findings

• Wide variations exist in degree of pharmaceutical
  reserve supplies and preparedness
• Several hospitals have developed extensive
  reserve supplies while others are very limited
• Given reported reserve supplies, responses may
  overestimate hospital capabilities during
  emergency scenarios

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Hospital Pharmaceutical Reserve Template
Strength/ Concentration Dosage Form Dosage Units Expiration Date
Ciprofloxacin 500 mg PO/ Tabs
250 mg PO/ Tabs
400 mg IV
500 mg/ 5 ml PO/ Susp
250 mg/ 5 ml PO/ Susp

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Project Scope

• Advisory group recommendation to focus on
  biological incident preparedness at the hospital
  level
• Assumption that community mass prophylaxis plans
  are fully implemented

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Hospital Pharmaceutical Reserve Guidance Document

• Post-Exposure Prophylaxis
• Each hospital should maintain appropriate
• antibiotics for Category A agents in a
  dedicated
• reserve supply for a 72 hour period
• - all hospital staff
• - immediate staff families
• - total inpatient capacity

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Hospital Pharmaceutical Reserve Guidance Document

• Treatment
• Each hospital should maintain appropriate
  antibiotics for Category A agents in a dedicated
  reserve supply for a 72 hour period in accordance
  with HRSA guidelines defined in critical
  benchmark 2-6.
• - 100 additional patients requiring
• treatment for each suburban/ urban
• hospital
• - 50 additional patients requiring
• treatment for each rural hospital

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Hospital Pharmaceutical Reserve Guidance Document

• Intended to define minimum standards for hospital
  pharmaceutical preparedness for biological
  incidents
• Guidance includes sample hospital calculations
• Includes pediatric considerations

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Region 3 Amount of Unit Doses Cipro 400 mg IV
and/or Doxy 100 mg IV Available at Each Hospital.
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Region 3 Required Doses of IV Cipro or Doxy for
Treatment of 100 Additional Patients By Hospitals
For 72 Hours Amount of IV Cipro and Doxy
Remaining Available Doses at Each Hospital. (Red
denotes a deficit.)
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Region 3 Combined Cipro/Doxy Available vs. Total
Required
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Statewide Combined Cipro/Doxy Available vs. Total
Required
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Regional Stockpile Planning

• Advisory group consensus to focus on category A
  biological preparedness, hospital level
• Based on hospital staffing calculations and
  patient projections, regional stockpile
  requirements were determined
• Antibiotic treatment and prophylaxis
  recommendations reviewed

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Regional Stockpile Planning

• Options
• - stock only ciprofloxacin
• - stock only doxycycline
• - stock a combination of
• cipro and doxycycline
• - stock cipro and doxycycline, no pediatrics
• - maximal coverage

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Regional Stockpile Planning

• Option 1 Stock only Ciprofloxacin
• Coverage for category A anthrax, plague,
  tularemia
• Coverage for category B Q fever
• Incomplete coverage for category B brucellosis,
  glanders
• Cipro 6143852 863112 units at 0.09 per
  unit (77,680) adult prophylaxis
• Cipro 61650 9900 units at 24.13 per unit
  (238,887) adult treatment
• Cipro 625532 153192 units at 3.90 per
  unit (597,449) pediatric prophylaxis
• Cipro 6550 3300 units at 24.13 per unit
  (79,629) pediatric treatment
• Total cost 993,645

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Regional Stockpile Planning

• Option 2 Stock only Doxycycline
• Coverage for category A anthrax, plague
• Coverage for category B Q fever, brucellosis,
  glanders
• Incomplete coverage for category A tularemia
  (no treatment) Incomplete coverage for category
  B brucellosis (need rifampin), glanders (no
  treatment)
• Doxycycline 6143852 863112 units at 0.04 per
  unit (34,524) adult prophylaxis
• Doxycycline 81650 13200 units at 3.98 per
  unit (52,536) adult treatment
• Doxycycline 625532 153192 units at 4.19 per
  unit (641,874) pediatric prophylaxis
• Doxycycline 8550 4400 units at 3.98 per unit
  (17,512) pediatric treatment
• Total cost 746,446

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Regional Stockpile Planning

• Option 3 Stock Ciprofloxacin and Doxycycline
• Cipro 6143852 863112 units at 0.09 per
  unit (77,680) adult prophylaxis
• Doxycycline 6143852 863112 units at 0.04 per
  unit (34,524) adult prophylaxis
• Cipro 61650 9900 units at 24.13 per unit
  (238,887) adult treatment
• Doxycycline 81650 13,200 units at 3.98 per
  unit (52,536) adult treatment
• Cipro 625532 153192 units at 3.90 per unit
  (597,449) pediatric prophylaxis
• Cipro 6550 3300 units at 24.13 per unit
  (79,629) pediatric treatment
• Total cost 1,080,705

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Additional Recommended Medications

• Albuterol Neb 3.64 for 30 units
• Albuterol Nebulizer masks 1.03
• Atropine 1mg 1.81/ 0.22
• Epinephrine (1mg/10cc) 1.70
• Valium (10mg IV) 0.34
• Phenergan (25mg IV) 1.00
• Dopamine (pre-mixed 400mg/250cc) 7.37
• MSO4 (10mg) 0.59
• Tylenol ES 3.00 for 150
• Motrin 400mg 1.83 for 100
• Botulinum antitoxin 466/ dose

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Next Steps

• Advisory group has opened dialogue with
  pharmaceutical vendors
• Partner agencies have applied for funding sources
  for stockpile startup costs (e.g. UASI)
• Consider establishing a hospital pharmaceutical
  response fund hospitals with significant
  reserves would have reduced contributions