1. 1 Pharmacists’ Roles in Emergency Preparedness CDR Louis Flowers LT Evan Wearne

2. 2 Objectives Describe the role of pharmacists Explain the responsibilities of OCTEC Summarize emergency response scenarios

3. 3 Pharmacists in Emergency Response and Preparedness

4. 4 Pharmacists’ Response to the September 11 th Attacks

5. 5 Pharmacists in Regulatory Affairs at CDC

6. 6 Pharmacists involved in FDA Emergency Response Activities

7. Talking Points FDA’s Responsibilities Office of Crisis Management CDER’s Mission History of OCTEC The CDER Incident Management Plan Response Activities

8. 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

9. FDA Responsibilities Assuring that foods are safe, wholesome, sanitary and properly labeled Protecting the public from electronic radiation Regulating Tobacco Products

10. FDA Organization

11. FDA Office of Crisis Management (OCM) OCM serves as the FDA’s focal point for coordinating emergency and crisis response activities

12. 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

13. Some Offices in CDER OND = Office of New Drugs, OSE = Office of Surveillance and Epidemiology, OC = Office of Compliance

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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.

21. 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.

22. 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.

23. 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

24. IMP Has never been activated Possible incidents: – –Natural disasters – –Contamination of a widely used medication – –Terrorist Attack

25. Emergency Response Emergency Investigational New Drug (eIND) Requests Emergency Use Authorization Developing Medical Countermeasures Emergency Coordination

26. 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

27. Influenza

28. Intravenous Relenza (zanamivir)

29. Accidental Ingestion

30. Vistonuridine (uridine triacetate)

31. Mushroom Poisoning

32. Legalon (silibinin)

33. 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

34. EUA’s 2009: Swine flu outbreak – –Oseltamivir – –Zanamivir – –Peramivir 2008: Anthrax Post Exposure Prophylaxis – –Doxycycline to postal workers

35. 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

36. Emergency Coordination Contaminated Cardiac Drugs in Pakistan

37. Summary As a pharmacist – –On Call for after-hour emergency requests – –Provide training through emergency exercises – –Emergency coordination during incidents

38. Questions LT Evan Wearne Evan.Wearne@fda.hhs.gov CDR Louis Flowers Louis.Flowers@fda.hhs.gov Evan.Wearne@fda.hhs.gov Louis.Flowers@fda.hhs.gov