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Pharmaceutical Response Planning for Public Health Emergencies Edbert Hsu, MD, MPH Johns Hopkins Office of Critical Event Preparedness and Response.
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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
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) Partner Agencies
Background CDC’s Strategic National Stockpile (SNS) Program was developed in 1999 to assist states and communities in responding to public health emergencies
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
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
Issue • Critical need for preparation on the part of state and local planners • Hospitals must be prepared for immediate response
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
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
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
Pharmaceutical Response Survey • Determination of hospital pharmaceutical response capacity for given biological, chemical and radiological scenarios • Cataloguing of pharmaceutical supplies by quantity and type
Key Findings • Strong participation from hospitals and pharmacists surveyed • A total of 36/45 hospitals throughout the state completed the survey • 80% response rate
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% Don´t Know (1) 3%
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% Don´t Know (4) 11%
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% Don´t Know (0) 0%
Key Findings • Would specific guidelines on maintaining optimal hospital pharmaceutical cache be useful in your facility’s preparedness planning? Yes (32) 89% No (0) 0% Don´t Know (4) 11%
Key Findings • Would emergency access to a local or regional reserve pharmaceutical stockpile be useful in your facility’s preparedness planning? Yes (35) 97% No (0) 0% Don´t Know (1) 3%
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
Project Scope • Advisory group recommendation to focus on biological incident preparedness at the hospital level • Assumption that community mass prophylaxis plans are fully implemented
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
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
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
Region 3 Amount of Unit Doses Cipro 400 mg IV and/or Doxy 100 mg IV Available at Each Hospital.
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.)
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
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
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 6*143852 = 863112 units at $0.09 per unit ($77,680) adult prophylaxis Cipro 6*1650 = 9900 units at $24.13 per unit ($238,887) adult treatment Cipro 6*25532 = 153192 units at $3.90 per unit ($597,449) pediatric prophylaxis Cipro 6*550 = 3300 units at $24.13 per unit ($79,629) pediatric treatment Total cost: $993,645
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 6*143852 = 863112 units at $0.04 per unit ($34,524) adult prophylaxis Doxycycline 8*1650 = 13200 units at $3.98 per unit ($52,536) adult treatment Doxycycline 6*25532 = 153192 units at $4.19 per unit ($641,874) pediatric prophylaxis Doxycycline 8*550 = 4400 units at $3.98 per unit ($17,512) pediatric treatment Total cost: $746,446
Regional Stockpile Planning • Option 3: Stock Ciprofloxacin and Doxycycline • Cipro 6*143852 = 863112 units at $0.09 per unit ($77,680) adult prophylaxis • Doxycycline 6*143852 = 863112 units at $0.04 per unit ($34,524) adult prophylaxis • Cipro 6*1650 = 9900 units at $24.13 per unit ($238,887) adult treatment • Doxycycline 8*1650 = 13,200 units at $3.98 per unit ($52,536) adult treatment • Cipro 6*25532 = 153192 units at $3.90 per unit ($597,449) pediatric prophylaxis • Cipro 6*550 = 3300 units at $24.13 per unit ($79,629) pediatric treatment • Total cost: $1,080,705
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
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