Transcript Methods: Expert input/feedback

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
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)
2
Background
CDC’s Strategic National
Stockpile (SNS)
Program was
developed in 1999 to
assist states and
communities in
responding to public
health emergencies
3
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
4
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
5
Issue


Critical need for preparation on the part
of state and local planners
Hospitals must be prepared for
immediate response
6
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
7
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
8
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
9
Pharmaceutical Response
Survey


Determination of hospital
pharmaceutical response capacity for
given biological, chemical and
radiological scenarios
Cataloguing of pharmaceutical supplies
by quantity and type
10
Key Findings



Strong participation from hospitals and
pharmacists surveyed
A total of 36/45 hospitals throughout
the state completed the survey
80% response rate
11
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%
12
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%
13
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%
14
Ciprofloxacin 500 mg Tablets
0
Hospital 222
Hospital 221
Hospital 220
Hospital 219
Hospital 218
Hospital 217
Hospital 216
Hospital 214
Hospital 213
Hospital 212
Hospital 211
Hospital 210
Hospital 209
Hospital 208
Hospital 207
Hospital 206
Hospital 205
Hospital 204
Hospital 203
4800
5400
300
20200
2000
2400
500
1000
300
135
44400
200
300
400
1000
1200
1750
200
0
5000
10000
15000
20000
25000
Number of Unit Dose
30000
35000
40000
45000
15
Ciprofloxacin 500 mg Tablets
0
Hospital 122
100
Hospital 120
0
Hospital 119
Hospital 118
1,000
0
Hospital 117
0
Hospital 116
0
Hospital 115
600
Hospital 114
700
Hospital 113
Hospital 112
0
Hospital 111
0
Hospital 109
0
100
Hospital 108
Hospital 106
0
Hospital 105
0
125
Hospital 104
1,000
Hospital 102
0
100
200
300
400
500
Number of Unit Dose
600
700
800
900
1,000
16
Doxycycline 100 mg Capsules
0
Hospital 222
Hospital 221
Hospital 220
Hospital 219
Hospital 218
Hospital 217
Hospital 216
Hospital 214
Hospital 213
Hospital 212
Hospital 211
Hospital 210
Hospital 209
Hospital 208
Hospital 207
Hospital 206
Hospital 205
Hospital 204
Hospital 203
2,400
13,944
800
10,200
90,000
22,300
200
0
200
85
800
0
800
300
2,000
10,000
45,550
400
0
10000
20000
30000
40000
50000
60000
70000
80000
90000
Number of Unit Doses
17
Doxycycline 100 mg Capsules
5,400
Hospital 122
Hospital 120
150
Hospital 119
0
Hospital 118
Hospital 117
0
7,500
700
Hospital 116
0
40
Hospital 115
Hospital 114
4,000
Hospital 113
2,000
Hospital 112
700
Hospital 111
Hospital 109
0
1,500
Hospital 108
2,000
1,800
Hospital 106
Hospital 105
150
Hospital 104
2,700
Hospital 102
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
Number of Unit Doses
18
Cyanide Antidote Kits
0
Hospital 222
Hospital 221
Hospital 220
Hospital 219
Hospital 218
Hospital 217
Hospital 216
Hospital 214
Hospital 213
Hospital 212
Hospital 211
Hospital 210
Hospital 209
Hospital 208
Hospital 207
Hospital 206
Hospital 205
20
2
2
6
8
2
0
0
1
23
2
1
2
5
2
0
1
Hospital 204
Hospital 203
6
0
5
10
15
20
25
Number of Unit Dose
19
Cyanide Antidote Kits
12
Hospital 122
5
Hospital 120
0
Hospital 119
Hospital 118
1
Hospital 117
1
1
Hospital 116
Hospital 115
1
Hospital 114
1
30
Hospital 113
0
Hospital 112
1
Hospital 111
0
Hospital 109
2
Hospital 108
0
Hospital 106
2
Hospital 105
1
Hospital 104
12
Hospital 102
0
5
10
15
20
25
30
Number of Unit Dose
20
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%
21
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%
22
Key Findings

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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
23
Hospital Pharmaceutical
Reserve Template
Ciprofloxacin
Strength/
Concentration
Dosage Form
500 mg
PO/ Tabs
250 mg
PO/ Tabs
400 mg
IV
500 mg/ 5 ml
PO/ Susp
250 mg/ 5 ml
PO/ Susp
#Dosage Units
Expiration Date
24
Project Scope


Advisory group recommendation to
focus on biological incident
preparedness at the hospital level
Assumption that community mass
prophylaxis plans are fully
implemented
25
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
26
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
28
Region 3 Amount of Unit Doses
Cipro 400 mg IV and/or Doxy 100
mg IV Available at Each Hospital.
222 0
221 0
220
219
218
217 0
40
216
214 0
213 0
45
212
211
210
209 0
208
207
206
205 0
75
204
203
48
0
220
150
170
1,248
150
150
150
252
200
400
600
800
1000
1200
1400
29
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.)
222
600
221 600
380
220
450
219
218
430
217 600
560
216
600
214
600
213
212
555
211
450
210
209 600
450
208
450
207
348
206
600
205
525
204
552
203
-600
-400
648
-200
0
200
400
600
800
30
Region 3 Combined Cipro/Doxy
Available vs. Total Required
1,000,000
13,200
14,000
863,112
900,000
12,000
800,000
10,000
700,000
600,000
8,000
500,000
400,000
Unit Doses
286,464
Unit Doses
6,000
300,000
4,000
2,698
200,000
100,000
2,000
0
Total Doses of
Ciprofloxacin &
Doxycyline (PO)
Total Doses
Required for
Prophylaxis
(PO)
0
Total Doses of
Ciprofloxacin &
Doxycyline (IV)
Total Doses
Required for
Treatm ent (IV)
31
Statewide Combined Cipro/Doxy
Available vs. Total Required
1,385,748
23,400
1,000,000
25,000
900,000
800,000
20,000
700,000
600,000
500,000
15,000
318,729
Unit Doses
400,000
Unit Doses
10,000
300,000
4,261
200,000
5,000
100,000
0
Total Doses of
Ciprofloxin &
Doxycyline (PO)
Total Doses
Needed (PO)
0
Total Dos e s of
Ciprofloxin &
Doxycyline (IV)
Total Dos e s
Ne e de d (IV)
32
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
33
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
34
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
35
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
36
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
37
Additional Recommended
Medications

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




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
38
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
39