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

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Objectives

Describe the role of pharmacists

Explain the responsibilities of OCTEC

Summarize emergency response scenarios

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Pharmacists in Emergency Response and Preparedness

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Pharmacists’ Response to the September 11th Attacks

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Pharmacists in Regulatory Affairs at CDC

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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

Questions

LT Evan WearneEvan.Wearne@fda.hhs.gov

CDR Louis FlowersLouis.Flowers@fda.hhs.gov