# Presentation: 320208

## Slide 1

## AERS is a scientific and analyses driven system !

## Pharmacovigilance is a Clinical Art 

## GOAL: PV Strategy

- Data to the e-Desktop
- Tools
- Document Management
- Flexible Query
- Data Displays
- Content Analyses
- Review Assist

## Primary Search Keys

- Suspect Drug (s)
- Key Reaction Term (s)
- Best Case

## Receipt (Report) Level 

**Receipt (Report) Level **

**Search (Case) Level**

**Analysis (Case Series) Level**

## Slide 7

## Pharmacovigilance Screening

**Risk Assessor**

**Electronic Inbox**

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signaling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Pharmacovigilance Screening**

## Risk Assessor

**Risk Assessor**

**Electronic Inbox**

- DPE’s PMS Risk Assessors will Receive
- ALL  Incoming ADR Reports in Differing
- Formats, at Differing
- Intervals
- Tier I
- Tier II
- Tier III
- Tier IV
- Desktop Query

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signaling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## Incoming ADR

**Reports**

- Three Broad Catagories in AERS
- Expedited and Direct Serious
- Periodic Serious
- incl. DMEs
- Periodic and Direct Non-Serious

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signalling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

##   I

**Tier **
**  ****I**

- Individual Safety Report (ISR)
- Are Those that Require Review at the
- _Single Report Level_
- 	- Expedited
- 	- Direct Serious
- 	- DME
- Action Required
- Expedited Judgement made by Firm

## PRIMARY SURVEILLANCE CRITERIA

**Non-Serious**

**Labeled**

**UnLabeled**

**DIRECT REPORTS**

**PRIMARY SURVEILLANCE CRITERIA**

**Serious**

**Non-Serious**

**Labeled**

**UnLabeled**

**MANUFACTURER REPORTS**

## Designated Medical Events (DMEs)(partial Listing)

- Congenital anomalies
- Acute resp failure
- Ventricular fibrillation
- Torsades de Pointe
- Malignant hypertension

- Seizures
- Agranulocytosis
- Aplastic anemia
- Toxic epidermal necrolysis
- Liver necrosis
- Acute liver failure
- Anaphylaxis

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signalling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## Tier II

**Tier ****II**

- Triggered by a Tier I Incoming
- 	(PT & Report Level)
- Provides Accumulated case counts based
- 	 that speciifc drug/reaction pair
- 	 (HLT and CASE level)
- Easy Conversion into Case Series &/or
- 	Ad Hoc Query Tools
- Pharmacovigilance as a Clinical Art

## Secondary Surveillance Quick Counts

- Counts Include:
- Number of Cases for the active ingredient/reaction combination
- Percent of Total Number of Cases for that active ingredient
- Number of Death Cases
- Number of Serious Cases (includes Death Cases)
- Print Secondary Surveillance Counts

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signalling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## Tier III

**Tier ****III**

- Uses the “EYE as a Statisical Tool
- All Incoming Reports across 6-10 graphic
- displays
- available/updated “weekly”

- Graphic Signaling

## TIER  III

- 1] Frequency distribution of Monthly incoming across  the 26 SOCs (color coded: Tier 1 vs other)
- 2] Frequency distribution  &/or Scattergram of Monthly incoming across  ~88 HLGTs (color coded Tier 1 vs. other)
- 3] Monthly incoming vs Data base for Top 40 IMT-HLT (~400) Terms (color coded: new vs. old)
- etc.

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signalling**

**Tier IV**

**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## Tier IV

**Tier ****IV**

- All reports viewed across 20-25 tabular,
- graphic (or both) displays
- Some produced on scheduled periodicity
- (in accordance with PSUR)

- Periodic: Tabular & Graphic

## ReportsTier IV - Tabular Periodic

- The following standard risk assessment reports will be available in AERS in tabular  and graphic (*) format:
- Cases by Gender and Age Group*
- Cases by Year and Quarter*
- Cases by Report Type*
- Cases by General Source*
- Cases by Region and State*
- Cases by Country*
- Cases by MEDDRA PT and SOC*
- Cases by suspect and Other Product Having 1 or More Products*
- Labeled vs. Unlabeled Data by MEDDRA PT and SOC
- MEDDRA PTs in Case
- Cases with Positive Dechallenge
- Cases with Positive Rechallenge
- Line Listing Summary of Cases
- Line Listing Summary of Cases with Narrative
- Microfiche/Image Numbers by Case

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signalling**

**Tier IV**

**Tabular **
**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## V

**Tier **
**V**

- Active Investigation
- Capacity to use pre-set
- report  forms
- (graphic, tabular and statistical)
- across specifically defined
- ad hoc variables

- Desktop Query Mode

## Desktop Query

## Pharmacovigilance Screening

**Periodic**

**Serious**

**Expedited**

**and Direct**

**Serious**

**Periodic and**

**Direct Non-**

**Serious**

- Special
- Reports

- Via
- SDPB

- DMEs

**Tier I**

**Tier II**

**Tier III**

**Graphic Signaling**

**Tier IV**

**Tabular **
**Periodic**

**Tier **
**V**

**Ad Hoc **
**Query**

**MISC**

**DMEs**

**Incoming ADR**

**Reports**

**Risk Assessor**

**Electronic Inbox**

**Pharmacovigilance Screening**

## Special Programming

- Inhouse Capacity to Program
- Any Type of Special Reports, not
- previously designed
- Can be added to TIER III , IV or V

## Slide 30