1. Pharmaceutical Response Planning for Public Health Emergencies Edbert Hsu, MD, MPH Johns 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

2. 2 Partner Agencies Department of Health and Mental Hygiene (DHMH) Department of Health and Mental Hygiene (DHMH) Maryland Board of Pharmacy Maryland Board of Pharmacy Baltimore City Health Department (BCHD) Baltimore City Health Department (BCHD) Maryland Emergency Management Agency (MEMA) Maryland Emergency Management Agency (MEMA) Maryland Institute for Emergency Medical Systems Services (MIEMSS) Maryland Institute for Emergency Medical Systems Services (MIEMSS) Maryland Society of Health System Pharmacists (MSHP) Maryland Society of Health System Pharmacists (MSHP)

3. 3 Background CDC’s Strategic National Stockpile (SNS) Program was developed in 1999 to assist states and communities in responding to public health emergencies

4. 4 Background Push packages (12), strategically located are scheduled to arrive within 12 hours of decision to deploy providing a broad spectrum of assets 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 Vendor managed inventory can follow within 24-36 hours when a specific threat is identified

5. 5 Purpose of SNS Designed to supplement state and local public health agencies in the event of a biological or chemical terrorism incident 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 Not considered a first response tool

6. 6 Issue Critical need for preparation on the part of state and local planners Critical need for preparation on the part of state and local planners Hospitals must be prepared for immediate response Hospitals must be prepared for immediate response

7. 7 Major Project Goals Assessment of existing regional hospital pharmaceutical supplies Assessment of existing regional hospital pharmaceutical supplies Establishment of guidelines for developing and maintaining optimal pharmaceutical cache at each hospital Establishment of guidelines for developing and maintaining optimal pharmaceutical cache at each hospital Planning for a regional pharmaceutical stockpile Planning for a regional pharmaceutical stockpile

8. 8 Pharmaceutical Response Survey Developed collaboratively with pharmacists and partner agencies Developed collaboratively with pharmacists and partner agencies Piloted with hospital pharmacists Piloted with hospital pharmacists Phase I administered to all Region 3 hospital pharmacists Phase I administered to all Region 3 hospital pharmacists Phase II conducted statewide Phase II conducted statewide

9. 9 Pharmaceutical Response Survey Hospital characteristics Hospital characteristics Determination of regional hospital pharmaceutical response preparedness Determination of regional hospital pharmaceutical response preparedness - specific protocols and written - specific protocols and written agreements agreements - access to emergency supply systems - access to emergency supply systems - delineated plans for coordination with - delineated plans for coordination with SNS assets and prior exercises SNS assets and prior exercises

10. 10 Pharmaceutical Response Survey Determination of hospital pharmaceutical response capacity for given biological, chemical and radiological scenarios Determination of hospital pharmaceutical response capacity for given biological, chemical and radiological scenarios Cataloguing of pharmaceutical supplies by quantity and type Cataloguing of pharmaceutical supplies by quantity and type

11. 11 Key Findings Strong participation from hospitals and pharmacists surveyed Strong participation from hospitals and pharmacists surveyed A total of 36/45 hospitals throughout the state completed the survey A total of 36/45 hospitals throughout the state completed the survey 80% response rate 80% response rate

12. 12 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? 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% Yes (33) 92% No (2) 6% No (2) 6% Don´t Know (1) 3% Don´t Know (1) 3%

13. 13 Key Findings Does your facility have any written agreements or memoranda of understanding (MOUs) for pooling or obtaining pharmaceutical and medical supplies? Does your facility have any written agreements or memoranda of understanding (MOUs) for pooling or obtaining pharmaceutical and medical supplies? Yes (26) 72% Yes (26) 72% No (6) 17% No (6) 17% Don´t Know (4) 11% Don´t Know (4) 11%

14. 14 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? 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% Yes (14) 39% No (22) 61% No (22) 61% Don´t Know (0) 0% Don´t Know (0) 0%

15. 15 Ciprofloxacin 500 mg Tablets

16. 16 Ciprofloxacin 500 mg Tablets

17. 17 Doxycycline 100 mg Capsules

18. 18 Doxycycline 100 mg Capsules

19. 19 Cyanide Antidote Kits

20. 20 Cyanide Antidote Kits

21. 21 Key Findings Would specific guidelines on maintaining optimal hospital pharmaceutical cache be useful in your facility’s preparedness planning? Would specific guidelines on maintaining optimal hospital pharmaceutical cache be useful in your facility’s preparedness planning? Yes (32) 89% Yes (32) 89% No (0) 0% No (0) 0% Don´t Know (4) 11% Don´t Know (4) 11%

22. 22 Key Findings Would emergency access to a local or regional reserve pharmaceutical stockpile be useful in your facility’s preparedness planning? Would emergency access to a local or regional reserve pharmaceutical stockpile be useful in your facility’s preparedness planning? Yes (35) 97% Yes (35) 97% No (0) 0% No (0) 0% Don´t Know (1) 3% Don´t Know (1) 3%

23. 23 Key Findings Wide variations exist in degree of pharmaceutical reserve supplies and preparedness Wide variations exist in degree of pharmaceutical reserve supplies and preparedness Several hospitals have developed extensive reserve supplies while others are very limited Several hospitals have developed extensive reserve supplies while others are very limited Given reported reserve supplies, responses may overestimate hospital capabilities during emergency scenarios Given reported reserve supplies, responses may overestimate hospital capabilities during emergency scenarios

24. 24 Hospital Pharmaceutical Reserve Template Strength/ Concentration Dosage Form#Dosage UnitsExpiration Date Ciprofloxacin500 mgPO/ Tabs 250 mgPO/ Tabs 400 mgIV 500 mg/ 5 mlPO/ Susp 250 mg/ 5 mlPO/ Susp

25. 25 Project Scope Advisory group recommendation to focus on biological incident preparedness at the hospital level Advisory group recommendation to focus on biological incident preparedness at the hospital level Assumption that community mass prophylaxis plans are fully implemented Assumption that community mass prophylaxis plans are fully implemented

26. 26 Hospital Pharmaceutical Reserve Guidance Document Post-Exposure Prophylaxis Each hospital should maintain appropriate Each hospital should maintain appropriate antibiotics for Category A agents in a dedicated antibiotics for Category A agents in a dedicated reserve supply for a 72 hour period: reserve supply for a 72 hour period: - all hospital staff - all hospital staff - immediate staff’ families - immediate staff’ families - total inpatient capacity - total inpatient capacity

27. 27 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 treatment for each suburban/ urban hospital hospital - 50 additional patients requiring - 50 additional patients requiring treatment for each rural hospital treatment for each rural hospital

28. 28 Hospital Pharmaceutical Reserve Guidance Document Intended to define minimum standards for hospital pharmaceutical preparedness for biological incidents Intended to define minimum standards for hospital pharmaceutical preparedness for biological incidents Guidance includes sample hospital calculations Guidance includes sample hospital calculations Includes pediatric considerations Includes pediatric considerations

29. 29 Region 3 Amount of Unit Doses Cipro 400 mg IV and/or Doxy 100 mg IV Available at Each Hospital.

30. 30 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.)

31. 31 Region 3 Combined Cipro/Doxy Available vs. Total Required

32. 32 Statewide Combined Cipro/Doxy Available vs. Total Required

33. 33 Regional Stockpile Planning Advisory group consensus to focus on category A biological preparedness, hospital level 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 Based on hospital staffing calculations and patient projections, regional stockpile requirements were determined Antibiotic treatment and prophylaxis recommendations reviewed Antibiotic treatment and prophylaxis recommendations reviewed

34. 34 Regional Stockpile Planning Options: Options: - stock only ciprofloxacin - stock only doxycycline - stock only doxycycline - stock a combination of - stock a combination of cipro and doxycycline cipro and doxycycline - stock cipro and doxycycline, no pediatrics - stock cipro and doxycycline, no pediatrics - maximal coverage - maximal coverage

35. 35 Regional Stockpile Planning Option 1: Stock only Ciprofloxacin 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

36. 36 Regional Stockpile Planning Option 2: Stock only Doxycycline 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

37. 37 Regional Stockpile Planning Option 3: Stock Ciprofloxacin and Doxycycline Option 3: Stock Ciprofloxacin and Doxycycline Cipro 6*143852 = 863112 units at $0.09 per unit ($77,680) adult prophylaxis 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 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 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 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*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 Cipro 6*550 = 3300 units at $24.13 per unit ($79,629) pediatric treatment Total cost: $1,080,705 Total cost: $1,080,705

38. 38 Additional Recommended Medications Albuterol Neb $3.64 for 30 units Albuterol Neb $3.64 for 30 units Albuterol Nebulizer masks $1.03 Albuterol Nebulizer masks $1.03 Atropine 1mg $1.81/ $0.22 Atropine 1mg $1.81/ $0.22 Epinephrine (1mg/10cc) $1.70 Epinephrine (1mg/10cc) $1.70 Valium (10mg IV) $0.34 Valium (10mg IV) $0.34 Phenergan (25mg IV) $1.00 Phenergan (25mg IV) $1.00 Dopamine (pre-mixed 400mg/250cc) $7.37 Dopamine (pre-mixed 400mg/250cc) $7.37 MSO4 (10mg) $0.59 MSO4 (10mg) $0.59 Tylenol ES $3.00 for 150 Tylenol ES $3.00 for 150 Motrin 400mg $1.83 for 100 Motrin 400mg $1.83 for 100 Botulinum antitoxin$466/ dose Botulinum antitoxin$466/ dose

39. 39 Next Steps Advisory group has opened dialogue with pharmaceutical vendors Advisory group has opened dialogue with pharmaceutical vendors Partner agencies have applied for funding sources for stockpile startup costs (e.g. UASI) 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 Consider establishing a hospital pharmaceutical response fund; hospitals with significant reserves would have reduced contributions