A partnership for adverse reaction reporting

Marsha Ford, MD - Director, Carolinas Poison Center

Amanda Fuller, PharmD – NC SNS Coordinator

The Initial Question

After a mass dispensing campaign begins, how are the adverse events monitored, collected and recorded?

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

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

CPC notified SNSCPC notified SNS meds to be dispensedmeds to be dispensed

CPC staffCPC staff activatedactivated

AHEC facultyAHEC faculty notifiednotified

PY4s contactedPY4s contacted & report to CPC& report to CPC

Training Training @ CPC@ CPC

PY4s answerPY4s answer calls at CPCcalls at CPC

Crisis resolving;Crisis resolving; call volume call volume

PY4s PY4s deactivateddeactivated

Normal CPCNormal CPCstaffing resumedstaffing resumed

September 24, 2007

Carolinas Poison Center Program Highlights and Surveillance Activities

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

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

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

CPC - Key Operational Metrics: Call Volume

CPC Call Volume by Month 2004 - Present

7,000

7,500

8,000

8,500

9,000

9,500

10,000

10,500

11,000

11,500

Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec

Ca

lls P

er

Mo

nth

2004 2005 2006 2007 2008

CPC Surge Capacity: Offsite Work Configuration

Cisco router

CPUCPU

Data Center

Service provider

Specialist

Carolinas Healthcare System

VPN/Cable

BellSouth VPN Or Cable w/

Forsythe Juniper Box

VPN/Cable

VPN/Cable

Nortelsoft phone

CPC

Utilize software to track specialist In-Call status, log-in and log-out

Communicate rapidly with off-site specialists via Instant Messaging

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

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