1 pharmacists’ roles in emergency preparedness cdr louis flowers lt evan wearne
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Pharmacists’ Roles in Emergency Preparedness
CDR Louis Flowers
LT Evan Wearne
22
Objectives
Describe the role of pharmacists
Explain the responsibilities of OCTEC
Summarize emergency response scenarios
33
Pharmacists in Emergency Response and Preparedness
44
Pharmacists’ Response to the September 11th Attacks
55
Pharmacists in Regulatory Affairs at CDC
66
Pharmacists involved in FDA Emergency Response Activities
Talking PointsFDA’s Responsibilities
Office of Crisis Management
CDER’s Mission
History of OCTEC
The CDER Incident Management Plan
Response Activities
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
FDA Responsibilities
Assuring that foods are safe, wholesome, sanitary and properly labeled
Protecting the public from electronic radiation
Regulating Tobacco Products
FDA Organization
FDA Office of Crisis Management (OCM)
OCM serves as the FDA’s focal point for coordinating emergency and crisis response activities
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
Some Offices in CDER
OND = Office of New Drugs, OSE = Office of Surveillance and Epidemiology, OC = Office of Compliance
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
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
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
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
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
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
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.
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.
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.
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
IMP
Has never been activated
Possible incidents:– Natural disasters– Contamination of a widely used medication– Terrorist Attack
Emergency Response
Emergency Investigational New Drug (eIND) Requests
Emergency Use Authorization
Developing Medical Countermeasures
Emergency Coordination
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
Influenza
Intravenous Relenza (zanamivir)
Accidental Ingestion
Vistonuridine (uridine triacetate)
Mushroom Poisoning
Legalon (silibinin)
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
EUA’s
2009: Swine flu outbreak– Oseltamivir– Zanamivir– Peramivir
2008: Anthrax Post Exposure Prophylaxis– Doxycycline to postal workers
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
Emergency Coordination
Contaminated Cardiac Drugs in Pakistan
Summary
As a pharmacist
– On Call for after-hour emergency requests
– Provide training through emergency exercises
– Emergency coordination during incidents
