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1 Overview of Pharmacovigilance at the Center for Veterinary Medicine (CVM) Tina Burgess, DVM Veterinary Medical Officer Division of Veterinary Product Safety Adverse Drug Experience (ADE) Reporting System Food and Drug Administration Center for Veterinary Medicine Division of Veterinary Product Safety: Dr. John Baker, Acting Director Team Leaders: Dr. Linda Walter-Grimm, Adverse Drug Event Review Team Dr. Lee Anne Palmer, Adverse Event Review Team Dr. Susan Bright, Data Management and Analysis Team Objectives: What is an ADE How to report an ADE Purpose of the ADE program Future of the ADE program

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Page 1: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Overview of Pharmacovigilanceat the

Center for Veterinary Medicine (CVM)

Tina Burgess, DVMVeterinary Medical Officer

Division of Veterinary Product Safety

Adverse Drug Experience (ADE) Reporting System

Food and Drug AdministrationCenter for Veterinary Medicine

Division of Veterinary Product Safety:Dr. John Baker, Acting Director

Team Leaders:Dr. Linda Walter-Grimm, Adverse Drug Event Review Team

Dr. Lee Anne Palmer, Adverse Event Review Team

Dr. Susan Bright, Data Management and Analysis Team

Objectives:

What is an ADEHow to report an ADEPurpose of the ADE programFuture of the ADE program

Page 2: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Pharmacovigilance StaffSafety Reviewers:Roderick Hudson, DVM Linda Walter-Grimm, DVMTeresa Koogler, DVM Tina Burgess, DVMSandi Ehnen, VMD Priscilla Batten, DVMTanya Martof, DVM Jennifer Smith, DVMAmy Neal, DVMLee Anne Palmer, VMD (Liaison for pet food adverse events)Margarita Brown, DVM, MS (Liaison for international adverse events)

Pharmacist: Linda Kim-Jung, PharmD

Epidemiologist: Renee Shibukawa-Kent, VMD, MPH, DACVPM

Medical Review: Susan Bright, DVM

Number of ADE ReportsAdverse Drug Event Reports

0

10000

20000

30000

40000

50000

60000

FY91 FY92 FY93 FY94 FY95 FY96 FY97 FY98 FY99 FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 FY08 FY09 FY10

Adverse Drug Experience(ADE)

An Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death). ADEs include complaints of ineffectiveness, product defects and human safety associated with the handling of animal drug products.

Page 3: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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New drugs (less than 3 yrs of marketing):

Reporting of ADE’s is especiallyimportant for new drugs to complete the safety profile

Since pre-approval data is limited, once new drugs are used in thousands of animals – new safety signals can emerge

Mandatory Adverse Event Reportingfor Manufacturers

Electronic GatewayForm 1932GuidanceTechnical Documents

Safety Reporting PortalRational Questionnaire

Guidance

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm

Electronic Submission Options

Mandatory Adverse Event Reportingfor Manufacturers(Paper Form 1932)

Page 4: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Voluntary ADE Reporting - Drugs

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htmBy phone :

Drug Company’s 800 #FDA: 888-FDA-VETS

By computerdownload form 1932a

Form 1932A:Mailed From The Consumer

Reporting a food adverse event

Website for “How to report a Pet Food complaint”:

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htmSafety Reporting Portal

Pet foods (general public; veterinarians)Reportable Foods Registry:

• for industry to report problems with foods

Page 5: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Reporting a non-drug adverse event

Veterinary Device: FDA/CVMFDA Form 1932a

Vaccine Reaction: USDA 800-752-6255

Pesticide Reaction: EPA 800-858-7378

ADE reports: Current ProcessReports triaged – manual data entryReviewed: new/recent approvals & hot topicsAnalyze data:

evaluate signals/trendsdevelop case series

MARC meetingsinteractive cross Center pharmacovigilance forumidentify and assess safety signal(s)develop risk mitigation response / plan of action

Page 6: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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CVM Databases and ProgramsSTARS

CVM’s current Submission Tracking and Review System

IERSCVM’s Information Exchange and Repository Services gateway for receipt of electronic submissions

PV WorksOff the shelf pharmacovigilance software product produced by Assured Information Systems and modified to meet the needs of FDA-CVM

Communication of our informationLabel revisions – PAE sections, warnings, formulation changes, product packagingDear Doctor lettersClient information sheetFreedom of Information (FOIA) requestsPost-approval risk management programsJournal articlesCumulative ADE summaries webpageCVM Updates (website)

Post-approval ADE section for labels:

After a drug has been on the market for 1 to 2 years, the primary safety reviewer completes an analysis of the ADE database to determine if there are signs to be added in a Post- Approval Experience (PAE) section.Periodic review of drug labels may reveal post-approval changes in the safety and effectiveness profile.

Page 7: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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FOI (Freedom of Information Act)

Reviewed ADE summaries are available to the public at the FDA website.

http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm

THIS SITE IS UPDATED MONTHLY

AMOXICILLINORAL, CAT

Number of Animals Evaluated 90

Sign HYPERESTHESIA

HYPERPNEA HYPERSALIVATION

HYPOTHERMIA HYPOTHERMIA, BODY

ICTERUS INEFFECT, ANTIBIOTIC

Page 8: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Future goalsOutreachVICHElectronic submission

Gateway to gatewaySafety Reporting portal

Data mining

VICH International Cooperation on Harmonization of Technical

Requirements for Registration of Veterinary Products

International harmonization of reporting adverse events

USA, EU, Japan • Canada, Australia

standardize definitionsstandardize data elementsstandardize dictionarieselectronic submission

Electronic Submissions

Automatic population of the databaseWorkflow managementIdentification of emerging problemsMore efficient data mining capabilities, even if the report has not yet been reviewed

Page 9: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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CVM ADE eReporting GoalsEnhanced capabilities for ADE triageIncreased efficiency of ADE data entryEnhanced capabilities for ADE data reviewView the data in the most appropriate way

Enhanced data analysisDecreased need for paper storage, both on-site and off-siteHarmonization of data fields will result in firms and CVM relying on “same data”Integrate eReporting into CVM’s current tracking system and work processes

What is Data Mining?• Definition: the use of computer algorithms to

analyze data in large, complex databases

• Goal: to discover patterns of associations or unexpected occurrences (i.e. “signals”)

• Impact: once meaningful patterns identified, information can be evaluated for intervention as appropriate

What Data Mining Can Do:

Signal potential problems quickly

Generate hypotheses regarding potential drug safety problems

Signal events that might be missed if a pattern is not expected

Page 10: Burgess ADE presentationAn Adverse Drug Experience is any adverse reaction that occurs following the use of a drug product. ADEs can be mild (itching, sneezing) to severe (death)

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Data Mining is a Tool For Finding Patterns…It Should Not Replace Our Own Eyes or Good Clinical Judgment

Questions?


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