Pharmaceutical Response Pharmaceutical Response Planning for Public Health Planning for Public Health EmergenciesEmergencies

Edbert Hsu, MD, MPHEdbert Hsu, MD, MPH

Johns Hopkins Office of Critical Johns Hopkins Office of Critical Event Preparedness and ResponseEvent Preparedness and Response

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

22

Partner AgenciesPartner Agencies

Department of Department of Health and Mental Health and Mental Hygiene (DHMH) Hygiene (DHMH)

Maryland Board of Maryland Board of PharmacyPharmacy

Baltimore City Baltimore City Health Department Health Department (BCHD)(BCHD)

Maryland Maryland Emergency Emergency Management Management Agency (MEMA)Agency (MEMA)

Maryland Institute Maryland Institute for Emergency for Emergency Medical Systems Medical Systems Services (MIEMSS)Services (MIEMSS)

Maryland Society of Maryland Society of Health System Health System Pharmacists (MSHP)Pharmacists (MSHP)

33

BackgroundBackground

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

44

BackgroundBackground

Push packages (12), strategically Push packages (12), strategically located are scheduled to arrive located are scheduled to arrive within 12 hours of decision to within 12 hours of decision to deploy providing a broad spectrum deploy providing a broad spectrum of assetsof assets

Vendor managed inventory can Vendor managed inventory can follow within 24-36 hours when a follow within 24-36 hours when a specific threat is identifiedspecific threat is identified

55

Purpose of SNSPurpose of SNS

Designed to supplement state and Designed to supplement state and local public health agencies in the local public health agencies in the event of a biological or chemical event of a biological or chemical terrorism incidentterrorism incident

Not considered a first response Not considered a first response tooltool

66

IssueIssue

Critical need for preparation on the Critical need for preparation on the part of state and local plannerspart of state and local planners

Hospitals must be prepared for Hospitals must be prepared for immediate responseimmediate response

77

Major Project GoalsMajor Project Goals

Assessment of existing regional Assessment of existing regional hospital pharmaceutical supplieshospital pharmaceutical supplies

Establishment of guidelines for Establishment of guidelines for developing and maintaining developing and maintaining optimal pharmaceutical cache at optimal pharmaceutical cache at each hospitaleach hospital

Planning for a regional Planning for a regional pharmaceutical stockpilepharmaceutical stockpile

88

Pharmaceutical Pharmaceutical Response Survey Response Survey

Developed collaboratively with Developed collaboratively with pharmacists and partner agenciespharmacists and partner agencies

Piloted with hospital pharmacistsPiloted with hospital pharmacists Phase I administered to all Region Phase I administered to all Region

3 hospital pharmacists3 hospital pharmacists Phase II conducted statewide Phase II conducted statewide

99

Pharmaceutical Pharmaceutical Response SurveyResponse Survey

Hospital characteristicsHospital characteristics Determination of regional hospital Determination of regional hospital

pharmaceutical response preparednesspharmaceutical response preparedness

- specific protocols and written- specific protocols and written

agreementsagreements

- access to emergency supply systems- access to emergency supply systems

- delineated plans for coordination - delineated plans for coordination withwith

SNS assets and prior exercises SNS assets and prior exercises

1010

Pharmaceutical Pharmaceutical Response SurveyResponse Survey

Determination of hospital Determination of hospital pharmaceutical response capacity pharmaceutical response capacity for given biological, chemical and for given biological, chemical and radiological scenariosradiological scenarios

Cataloguing of pharmaceutical Cataloguing of pharmaceutical supplies by quantity and type supplies by quantity and type

1111

Key FindingsKey Findings

Strong participation from Strong participation from hospitals and pharmacists hospitals and pharmacists surveyed surveyed

A total of 36/45 hospitals A total of 36/45 hospitals throughout the state completed throughout the state completed the surveythe survey

80% response rate80% response rate

1212

Key FindingsKey Findings

Has your facility/ system assessed Has your facility/ system assessed its pharmaceutical inventory to its pharmaceutical inventory to determine whether it could support determine whether it could support the treatment and prophylaxis for the treatment and prophylaxis for patients exposed to patients exposed to biologicalbiological agents? agents?

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

1313

Key FindingsKey Findings

Does your facility have any written Does your facility have any written agreements or memoranda of agreements or memoranda of understanding (MOUs) for pooling understanding (MOUs) for pooling or obtaining pharmaceutical and or obtaining pharmaceutical and medical supplies?medical supplies?

Yes (26) 72%Yes (26) 72% No (6) 17%No (6) 17% Don´t Know (4) 11%Don´t Know (4) 11%

1414

Key FindingsKey Findings

Has your facility/ system identified an Has your facility/ system identified an emergency pharmaceutical supply emergency pharmaceutical supply system via pharmaceutical vendors system via pharmaceutical vendors related to the prophylaxis and related to the prophylaxis and treatment for exposure to biological treatment for exposure to biological agents?agents?

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

1515

Ciprofloxacin 500 mg TabletsCiprofloxacin 500 mg Tablets

2001750

1200

1000

400

300

200

44400135

300

1000

5002400

2000

20200

3005400

48000

0 5000 10000 15000 20000 25000 30000 35000 40000 45000

Number of Unit Dose

Hospital 203

Hospital 204

Hospital 205

Hospital 206

Hospital 207

Hospital 208

Hospital 209

Hospital 210Hospital 211

Hospital 212

Hospital 213

Hospital 214

Hospital 216

Hospital 217

Hospital 218

Hospital 219

Hospital 220

Hospital 221

Hospital 222

1616

Ciprofloxacin 500 mg TabletsCiprofloxacin 500 mg Tablets

1,000125

0

0

100

0

0

0

700

600

0

00 1,000

0

1000

0 100 200 300 400 500 600 700 800 900 1,000

Number of Unit Dose

Hospital 102

Hospital 104

Hospital 105

Hospital 106

Hospital 108

Hospital 109

Hospital 111

Hospital 112

Hospital 113

Hospital 114

Hospital 115

Hospital 116

Hospital 117

Hospital 118

Hospital 119

Hospital 120

Hospital 122

1717

40045,550

10,0002,000

300

800

080085

2000200

22,300

90,00010,200800

13,944

2,400

0

0 10000 20000 30000 40000 50000 60000 70000 80000 90000

Number of Unit Doses

Hospital 203Hospital 204

Hospital 205Hospital 206

Hospital 207Hospital 208

Hospital 209Hospital 210

Hospital 211Hospital 212

Hospital 213

Hospital 214Hospital 216

Hospital 217Hospital 218

Hospital 219Hospital 220

Hospital 221Hospital 222

Doxycycline 100 mg Capsules

1818

Doxycycline 100 mg Capsules

2,700

150

1,800

2,000

1,500

0

700

2,000

4,000

40

0

700

0

7,5000

150

5,400

0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000

Number of Unit Doses

Hospital 102

Hospital 104

Hospital 105

Hospital 106

Hospital 108

Hospital 109

Hospital 111

Hospital 112

Hospital 113

Hospital 114

Hospital 115

Hospital 116

Hospital 117

Hospital 118

Hospital 119

Hospital 120

Hospital 122

1919

61

0

25

21

2321

0

02

86

22

200

0 5 10 15 20 25

Number of Unit Dose

Hospital 203

Hospital 204

Hospital 205

Hospital 206

Hospital 207

Hospital 208

Hospital 209

Hospital 210

Hospital 211

Hospital 212

Hospital 213

Hospital 214

Hospital 216

Hospital 217

Hospital 218

Hospital 219

Hospital 220

Hospital 221

Hospital 222

Cyanide Antidote Kits

2020

Cyanide Antidote Kits

12

12

0

2

0

1

0

301

1

11

1

0

512

0 5 10 15 20 25 30

Number of Unit Dose

Hospital 102

Hospital 104

Hospital 105

Hospital 106

Hospital 108

Hospital 109

Hospital 111

Hospital 112

Hospital 113

Hospital 114

Hospital 115

Hospital 116

Hospital 117

Hospital 118

Hospital 119

Hospital 120

Hospital 122

2121

Key FindingsKey Findings

Would specific guidelines on Would specific guidelines on maintaining optimal hospital maintaining optimal hospital pharmaceutical cache be useful in pharmaceutical cache be useful in your facility’s preparedness your facility’s preparedness planning?planning?

Yes (32) 89%Yes (32) 89% No (0) 0%No (0) 0% Don´t Know (4) 11%Don´t Know (4) 11%

2222

Key FindingsKey Findings

Would emergency access to a local Would emergency access to a local or regional reserve pharmaceutical or regional reserve pharmaceutical stockpile be useful in your facility’s stockpile be useful in your facility’s preparedness planning?preparedness planning?

Yes (35) 97%Yes (35) 97% No (0) 0%No (0) 0% Don´t Know (1) 3%Don´t Know (1) 3%

2323

Key FindingsKey Findings

Wide variations exist in degree of Wide variations exist in degree of pharmaceutical reserve supplies pharmaceutical reserve supplies and preparednessand preparedness

Several hospitals have developed Several hospitals have developed extensive reserve supplies while extensive reserve supplies while others are very limitedothers are very limited

Given reported reserve supplies, Given reported reserve supplies, responses may overestimate responses may overestimate hospital capabilities during hospital capabilities during emergency scenarios emergency scenarios

2424

Hospital Pharmaceutical Hospital Pharmaceutical Reserve TemplateReserve 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

2525

Project ScopeProject Scope

Advisory group recommendation Advisory group recommendation to focus on biological incident to focus on biological incident preparedness at the hospital levelpreparedness at the hospital level

Assumption that community mass Assumption that community mass prophylaxis plans are fully prophylaxis plans are fully implementedimplemented

2626

Hospital Pharmaceutical Hospital Pharmaceutical Reserve Guidance Reserve Guidance DocumentDocumentPost-Exposure ProphylaxisPost-Exposure Prophylaxis

Each hospital should maintain appropriateEach hospital should maintain appropriate antibiotics for Category A agents in a antibiotics for Category A agents in a

dedicateddedicated 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

2727

Hospital Pharmaceutical Hospital Pharmaceutical Reserve Guidance Reserve Guidance DocumentDocumentTreatmentTreatment

Each hospital should maintain appropriate Each hospital should maintain appropriate antibiotics for Category A agents in a antibiotics for Category A agents in a dedicated reserve supply for a 72 hour dedicated reserve supply for a 72 hour period in accordance with HRSA guidelines period in accordance with HRSA guidelines defined in critical benchmark 2-6. defined in critical benchmark 2-6. - 100 additional patients requiring- 100 additional patients requiring

treatment for each suburban/ urbantreatment for each suburban/ urban hospitalhospital - 50 additional patients requiring- 50 additional patients requiring treatment for each rural hospitaltreatment for each rural hospital

2828

Hospital Pharmaceutical Hospital Pharmaceutical Reserve Guidance Reserve Guidance DocumentDocument Intended to define minimum Intended to define minimum

standards for hospital standards for hospital pharmaceutical preparedness for pharmaceutical preparedness for biological incidents biological incidents

Guidance includes sample Guidance includes sample hospital calculationshospital calculations

Includes pediatric considerationsIncludes pediatric considerations

2929

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

4875

0252

150150

0

1,24815045

00

400

170150

22000

0 200 400 600 800 1000 1200 1400

203204205206207208209210211212213214216217218219220221222

3030

Region 3 Required Doses of IV Cipro or Region 3 Required Doses of IV Cipro or Doxy for Treatment of 100 Additional Doxy for Treatment of 100 Additional Patients By Hospitals For 72 Hours – Patients By Hospitals For 72 Hours – Amount of IV Cipro and Doxy = Amount of IV Cipro and Doxy = Remaining Available Doses at Each Remaining Available Doses at Each Hospital. (Hospital. (*Red denotes a deficit.*Red denotes a deficit.))

552525

600348

450450

600648

450555

600600560

600430

450380

600600

-600 -400 -200 0 200 400 600 800

203204205206207208209210211212213214216217218219220221222

3131

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

286,464

863,112

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

Total Doses ofCiprofloxacin &Doxycyline (PO)

Total DosesRequired forProphylaxis

(PO)

Unit Doses

2,698

13,200

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

Total Doses ofCiprofloxacin &Doxycyline (IV)

Total DosesRequired for

Treatment (IV)

Unit Doses

3232

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

318,729

1,385,748

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

Total Doses ofCiprofloxin &

Doxycyline (PO)

Total DosesNeeded (PO)

Unit Doses

4,261

23,400

0

5,000

10,000

15,000

20,000

25,000

Total Doses ofCiprofloxin &

Doxycyline (IV)

Total DosesNeeded (IV)

Unit Doses

3333

Regional Stockpile Regional Stockpile PlanningPlanning

Advisory group consensus to focus on Advisory group consensus to focus on category A biological preparedness, category A biological preparedness, hospital levelhospital level

Based on hospital staffing calculations Based on hospital staffing calculations and patient projections, regional and patient projections, regional stockpile requirements were stockpile requirements were determineddetermined

Antibiotic treatment and prophylaxis Antibiotic treatment and prophylaxis recommendations reviewed recommendations reviewed

3434

Regional Stockpile Regional Stockpile PlanningPlanning

Options:Options:

- stock only ciprofloxacin- stock only ciprofloxacin

- stock only doxycycline- stock only doxycycline

- stock a combination of- stock a combination of

cipro and doxycyclinecipro and doxycycline

- stock cipro and doxycycline, no - stock cipro and doxycycline, no pediatricspediatrics

- maximal coverage- maximal coverage

3535

Regional Stockpile Regional Stockpile PlanningPlanning Option 1: Stock only CiprofloxacinOption 1: Stock only Ciprofloxacin

Coverage for category A: anthrax, plague, tularemiaCoverage for category A: anthrax, plague, tularemiaCoverage for category B: Q feverCoverage for category B: Q feverIncomplete coverage for category B: brucellosis, Incomplete coverage for category B: brucellosis, glandersglanders

Cipro 6*143852 = 863112 units at $0.09 per unit Cipro 6*143852 = 863112 units at $0.09 per unit ($77,680) adult prophylaxis($77,680) adult prophylaxisCipro 6*1650 = 9900 units at $24.13 per unit Cipro 6*1650 = 9900 units at $24.13 per unit ($238,887) adult treatment($238,887) adult treatmentCipro 6*25532 = 153192 units at $3.90 per unit Cipro 6*25532 = 153192 units at $3.90 per unit ($597,449) pediatric prophylaxis($597,449) pediatric prophylaxisCipro 6*550 = 3300 units at $24.13 per unit ($79,629) Cipro 6*550 = 3300 units at $24.13 per unit ($79,629) pediatric treatmentpediatric treatmentTotal cost: $993,645Total cost: $993,645

3636

Regional Stockpile Regional Stockpile PlanningPlanning Option 2: Stock only DoxycyclineOption 2: Stock only Doxycycline

Coverage for category A: anthrax, plagueCoverage for category A: anthrax, plagueCoverage for category B: Q fever, brucellosis, glandersCoverage for category B: Q fever, brucellosis, glandersIncomplete coverage for category A: tularemia (no Incomplete coverage for category A: tularemia (no treatment); Incomplete coverage for category B: brucellosis treatment); Incomplete coverage for category B: brucellosis (need rifampin), glanders (no treatment)(need rifampin), glanders (no treatment)

Doxycycline 6*143852 = 863112 units at $0.04 per unit Doxycycline 6*143852 = 863112 units at $0.04 per unit ($34,524) adult prophylaxis($34,524) adult prophylaxisDoxycycline 8*1650 = 13200 units at $3.98 per unit Doxycycline 8*1650 = 13200 units at $3.98 per unit ($52,536) adult treatment ($52,536) adult treatment Doxycycline 6*25532 = 153192 units at $4.19 per unit Doxycycline 6*25532 = 153192 units at $4.19 per unit ($641,874) pediatric prophylaxis($641,874) pediatric prophylaxisDoxycycline 8*550 = 4400 units at $3.98 per unit ($17,512) Doxycycline 8*550 = 4400 units at $3.98 per unit ($17,512) pediatric treatmentpediatric treatmentTotal cost: $746,446Total cost: $746,446

3737

Regional Stockpile Regional Stockpile PlanningPlanning Option 3: Stock Ciprofloxacin and DoxycyclineOption 3: Stock Ciprofloxacin and Doxycycline Cipro 6*143852 = 863112 units at $0.09 per unit Cipro 6*143852 = 863112 units at $0.09 per unit

($77,680) adult prophylaxis($77,680) adult prophylaxis Doxycycline 6*143852 = 863112 units at $0.04 per unit Doxycycline 6*143852 = 863112 units at $0.04 per unit

($34,524) adult prophylaxis($34,524) adult prophylaxis Cipro 6*1650 = 9900 units at $24.13 per unit ($238,887) Cipro 6*1650 = 9900 units at $24.13 per unit ($238,887)

adult treatmentadult treatment Doxycycline 8*1650 = 13,200 units at $3.98 per unit Doxycycline 8*1650 = 13,200 units at $3.98 per unit

($52,536) adult treatment ($52,536) adult treatment Cipro 6*25532 = 153192 units at $3.90 per unit Cipro 6*25532 = 153192 units at $3.90 per unit

($597,449) pediatric prophylaxis($597,449) pediatric prophylaxis Cipro 6*550 = 3300 units at $24.13 per unit ($79,629) Cipro 6*550 = 3300 units at $24.13 per unit ($79,629)

pediatric treatmentpediatric treatment Total cost: $1,080,705Total cost: $1,080,705

3838

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

3939

Next StepsNext Steps

Advisory group has opened dialogue Advisory group has opened dialogue with pharmaceutical vendorswith pharmaceutical vendors

Partner agencies have applied for Partner agencies have applied for funding sources for stockpile startup funding sources for stockpile startup costs (e.g. UASI)costs (e.g. UASI)

Consider establishing a hospital Consider establishing a hospital pharmaceutical response fund; pharmaceutical response fund; hospitals with significant reserves hospitals with significant reserves would have reduced contributionswould have reduced contributions