A partnership for adverse reaction reporting

1. A partnership for adverse reaction reporting Marsha Ford, MD - Director, Carolinas Poison Center Amanda Fuller, PharmD – NC SNS Coordinator

2. The Initial Question • After a mass dispensing campaign begins, how are the adverse events monitored, collected and recorded?

3. The Needs • A way to take numerous calls • A consistent way to collect data • A method to transmit data to the state in a timely fashion • A method to report to FDA any ADRs reported when required • A single reporting system for medication and vaccination adverse events

4. The Plan • CPC is a part of the NC PHPR call down • Notification can go from PHPR to CPC or CPC to PHPR • CPC will call in additional staff as needed • Local Health Depts will route medication related questions to direct CPC number

5. CPC notified SNS meds to be dispensed CPC staff activated AHEC faculty notified PY4s contacted & report to CPC Normal CPC staffing resumed PY4s deactivated Training @ CPC Crisis resolving; call volume  PY4s answer calls at CPC

6. Carolinas Poison Center Program Highlights and Surveillance Activities

7. Carolinas Poison Center: Operations • NC-designated PC • Staffed • 24/7/365 • RNs/Pharmacists • Toxicologists: 3 MD & 1 PharmD • Administrative & support staff • AAPCC-certified • Utilize national toll-free number, 800-222-1222

8. Carolinas Poison Center: Operations • Data • Collected & entered by Specialists as part of case management • Electronically maintained with frequent backup • Case data uploaded every 6-10 minutes to the National Poison Data System - NPDS (formerly TESS) • Case data uploaded every hour to NC DETECT • Pesticide case data uploaded every 24 hours to NC DPH Occupational Epidemiology • Resources • Computerized information databases • Books, guidelines, internet • Public Health: preparedness & epidemiology • EMS: Dispatch and All Hazards personnel • Calls digitally recorded

9. CPC - Scope of Services • Exposure Calls – Triage, diagnose, provide expert advice • Pharmaceuticals • Drugs of abuse • Household products • Chemicals • Plants, Bites/stings • Food-borne illnesses • Information Calls • Public Health – collaborate with NC DHHS • Occupational pesticide exposures • Surveillance & investigation of All-Hazards incidents • Education & Prevention: Professional & Public • Research

10. CPC - Key Operational Metrics: Call Volume

11. CPU CPC Surge Capacity: Offsite Work Configuration Carolinas Healthcare System Data Center VPN/Cable BellSouth VPN Or Cable w/ Forsythe Juniper Box VPN/Cable Service provider Cisco router VPN/Cable CPC Specialist Nortel soft phone

12. Utilize software to track specialist In-Call status, log-in and log-out • Communicate rapidly with off-site specialists via Instant Messaging

13. CPC - Surge Capacity Response • Twenty-two off-site workplaces exist • System is used daily • Must be maintained and upgraded • In event of surge • Current staff will work off-site • Pharmacy students will work in the poison center, supervised, to answer questions from public

14. CPC – Public Health Surge Response • Guidelines and Q&A sheets • To handle anticipated pandemic & all-hazards events • Cross-train alternative providers to answer questions from public during outbreaks • Utilize guidelines and Q&A sheets • Just-in-time training • Data uploaded to DPH every hour • Real-time communication between CPC toxicologists and DPH