1 pharmacists’ roles in emergency preparedness cdr louis flowers lt evan wearne
TRANSCRIPT
![Page 1: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/1.jpg)
11
Pharmacists’ Roles in Emergency Preparedness
CDR Louis Flowers
LT Evan Wearne
![Page 2: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/2.jpg)
22
Objectives
Describe the role of pharmacists
Explain the responsibilities of OCTEC
Summarize emergency response scenarios
![Page 3: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/3.jpg)
33
Pharmacists in Emergency Response and Preparedness
![Page 4: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/4.jpg)
44
Pharmacists’ Response to the September 11th Attacks
![Page 5: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/5.jpg)
55
Pharmacists in Regulatory Affairs at CDC
![Page 6: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/6.jpg)
66
Pharmacists involved in FDA Emergency Response Activities
![Page 7: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/7.jpg)
Talking PointsFDA’s Responsibilities
Office of Crisis Management
CDER’s Mission
History of OCTEC
The CDER Incident Management Plan
Response Activities
![Page 8: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/8.jpg)
FDA’s Responsibilities
Assuring human and veterinary drugs, vaccines and other biological products and medical devices are safe and effective
Assuring cosmetics and dietary supplements are safe and properly labeled
![Page 9: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/9.jpg)
FDA Responsibilities
Assuring that foods are safe, wholesome, sanitary and properly labeled
Protecting the public from electronic radiation
Regulating Tobacco Products
![Page 10: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/10.jpg)
FDA Organization
![Page 11: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/11.jpg)
FDA Office of Crisis Management (OCM)
OCM serves as the FDA’s focal point for coordinating emergency and crisis response activities
![Page 12: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/12.jpg)
Center for Drug Evaluation and Research (CDER)
CDER ensures the availability of safe and effective drugs
CDER regulates over-the-counter and prescription drugs– Toothpaste, antiperspirants, sunscreens– Biological therapeutics and generic drugs
![Page 13: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/13.jpg)
Some Offices in CDER
OND = Office of New Drugs, OSE = Office of Surveillance and Epidemiology, OC = Office of Compliance
![Page 14: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/14.jpg)
Office of Counter-Terrorism and Emergency Coordination (OCTEC)
Facilitates the development of safe and effective medical countermeasures for chemical, biological, radiological, and nuclear threats.
Coordinates CDER activities related to emergency situations involving CDER regulated products and facilities
![Page 15: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/15.jpg)
OCTEC History
Began as Office of Pediatric Drug Development and Special Initiatives
After 9/11 occurred, more funding– Office of Counter-Terrorism and Pediatric Drug Development
Pediatric Drug Development moved to the Office of New Drugs
Became Office of Counter-Terrorism and Emergency Coordination in 2006
![Page 16: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/16.jpg)
OCTEC’s roles
Facilitating the development of medical countermeasures (MCM)– The Animal Rule
Maintains and exercises CDER’s Continuity of Operations Plan
Coordinates emergency and crisis situations
![Page 17: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/17.jpg)
Homeland Security Presidential Directive 5 (HSPD-5)
Directed Secretary of Homeland Security to develop a National Incident Management System (NIMS)
Requires all Federal departments and agencies to adopt NIMS and use it in their incident management programs
![Page 18: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/18.jpg)
HSPD-5 at FDA
OCM developed FDA’s Emergency Operations Plan (EOP)
CDER developed the CDER Incident Management Plan to support and complement the FDA’s EOP
![Page 19: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/19.jpg)
CDER Emergency Coordinator
Acts as a single point of contact between CDER and the FDA Office of Crisis Management
Is available by phone or email at all times
Can manage the majority of incidents alone
![Page 20: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/20.jpg)
Emergency
An Emergency is an incident that requires dedicated effort for coordination support by a single CDER Emergency Coordinator (CEC) but does not require activation of additional resources.
![Page 21: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/21.jpg)
Crisis
A crisis is an incident that requires dedicated coordination support, exceeds the ability of a single CEC to manage, and requires activation of one or more crisis management resources.
![Page 22: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/22.jpg)
Emergency Coordination
CDER receives, on a daily basis, reports of adverse events, potential product quality concerns, emergency investigational new drug (IND) requests, and various other issues requiring rapid assessment and response.
Many of these assessments and responses are handled through established procedures within the responsible operating unit.
![Page 23: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/23.jpg)
CDER Incident Management Plan (IMP)
If the incident becomes too complex or large for the CEC to coordinate– A determination will be made if the emergency
rises to the level of a crisis
If a crisis is declared, the IMP will be activated
![Page 24: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/24.jpg)
IMP
Has never been activated
Possible incidents:– Natural disasters– Contamination of a widely used medication– Terrorist Attack
![Page 25: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/25.jpg)
Emergency Response
Emergency Investigational New Drug (eIND) Requests
Emergency Use Authorization
Developing Medical Countermeasures
Emergency Coordination
![Page 26: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/26.jpg)
After-hour eIND Requests
Physician may request an eIND, if– Serious or life threatening disease– No alternative therapy– No existing clinical trials
Physicians contact the manufacturer before the FDA
![Page 27: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/27.jpg)
Influenza
![Page 28: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/28.jpg)
Intravenous Relenza (zanamivir)
![Page 29: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/29.jpg)
Accidental Ingestion
![Page 30: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/30.jpg)
Vistonuridine (uridine triacetate)
![Page 31: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/31.jpg)
Mushroom Poisoning
![Page 32: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/32.jpg)
Legalon (silibinin)
![Page 33: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/33.jpg)
Emergency Use Authorization
Project BioShield Act of 2004
– Emergency declared by Secretary of HHS
– FDA permitted to approve emergency use
– Allow off-label use in defined situations
![Page 34: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/34.jpg)
EUA’s
2009: Swine flu outbreak– Oseltamivir– Zanamivir– Peramivir
2008: Anthrax Post Exposure Prophylaxis– Doxycycline to postal workers
![Page 35: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/35.jpg)
Medical Countermeasures
Approvals under the Animal Rule
– Pyridostigmine Bromide (2003)Prophylaxis against Soman nerve gas
– Cyanokit (2006)Antidote for cyanide poisoning
– Levaquin (2012)Treatment of pneumonic plague
![Page 36: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/36.jpg)
Emergency Coordination
Contaminated Cardiac Drugs in Pakistan
![Page 37: 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne](https://reader036.vdocuments.site/reader036/viewer/2022081512/5697c0211a28abf838cd28dc/html5/thumbnails/37.jpg)
Summary
As a pharmacist
– On Call for after-hour emergency requests
– Provide training through emergency exercises
– Emergency coordination during incidents