Appendix_D_-_Final_DSI_May_2015_6_Month_Review_050615.pdf

FDA FAERS

DATA MANAGEMENT

PROGRAM

CDER FAERS – DMP Program Review

May 08, 2015

Diamond Solutions, Inc.

FAERS-DMP AGENDA

Introduction of team members and personnel

Program accomplishments

Program activities within FAERS-DMP

Performance and Statistical review

Summary

Questions

FAERS-DMP DSI TEAM

Diamond Solutions, Inc. – Earl Brown, CEO Grady Wright, COO

Bob Padgett, PM FDA IDIQ

HeiTech Services – Heidi Gerding, CEO

Zimmerman Associates, Inc. – Mary Blevins, CEO

FAERS-DMP CDER TEAM

Gerald Dal Pan, MD – Director of OSE

Marni Hall PhD OSE/RSS – Director Regulatory Science Staff

Tina Nguyen – FDA-DMP IDIQ COR

Captain John Quinn OSE/RSS – COR Project Officer

Jennifer Fagan OAGS – Contract Officer

Narissa Charles OAGS – Contract Specialist

Krishna Chary OSE/RSS – FDA Onsite Representative

Pham Quocbao OSE/RSS – FDA Onsite Representative

Thang La OSE/RSS – FDA Onsite Representative

FAERS-DMP

MANAGEMENT STRUCTURE

Christopher Eley Program Manager

Nadirah Rashada-Document Control Center Supervisor

Crystal Walker-Cooper

Central Triage Unit Pharmacist

Steven Huddleston Data Entry, Coding & Imaging Supervisor

Manish Kalaria Validation & QA

Supervisor

ACCOMPLISHMENTS

FAERS 2014 Six Month

September 2014 - January 2015:

Expedited paper cases are completed at 4 days processing

Direct paper cases are completed at 4 days processing

Non-Expedited paper cases are completed at 48 days processing

All Electronic cases are completed at 2 days processing (Non-Expedited/Expedited)

ACCOMPLISHMENTS

In 2014 we completed 130,295 paper cases. This is the most paper cases completed since 2006.

2006 2007 2008 2009 2010 2011 2012 2013 2014

Total 178,869 127,858 123,565 105,904 103,697 101,428 112,093 117,239 130,295

Non Expedited 60,545 49,698 29,346 18,381 25,008 27,406 40,846 28,885 44,378

Expedited 97,345 55,128 61,323 53,358 49,743 51,763 46,922 59,968 51,671

Direct 20,979 23,032 32,896 34,165 28,946 22,259 24,325 28,386 34,246

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

A xi s Ti tl e

YEARLY PAPER COUNT COMPARISON

The “Quality Enhancement Program” was started in Q4 2013 and has proven to be successful. It allows for Double Data Entry QC in the areas of Data Entry and Validation.

“The COR has commented that the Quarterly Data Extract Program is picking up significantly less errors since the training program has been implemented.

ACTIVITIES

FAERS-DMP ACTIVITIES

TO16 (E2B QA Program) - Started December 2014

This is a program that provides the Validators an opportunity to perform Quality

Assurance on the 98% of the electronic cases that skip Data Entry and goes directly to the Safety Evaluators.

Completed 2014 Q3

Completed 2014 Q4

Moving forward: Switched from Quarterly to Monthly QA

Currently processing January 2015 E2B submissions

38 cases per manufacturer

105 manufacturers

DMEPA - working with Jo Wyeth and Dr. Sonja Brajovic to specifically examine or QA E2B Medication Error reports

In June 2015, the E2B Mandation will become a law. This law states that “all mandatory reports will no longer be accepted via paper submission, but electronically via the E2B Gateway or the Safety Reporting Portal (SRP).”

How does this impact the FAERS-DMP contract?

70% of all paper cases will be submitted electronically, leaving only paper voluntary reports (about 30,000 Direct reports)

In anticipation and in the hope that manufacturers would start submitting electronically early thereby reducing the paper volume, the FAERS-DMP staff was reduced by 36% on January 30, 2015.

However, since the staff reduction, the paper volume has not decreased, but it has increased. This is making it nearly impossible for the reduced FAERS-DMP staff to satisfy the 7 contractual days processing obligation. Direct and Expedited paper went from 4 days processing to 11 days processing in one month.

Since the staff reduction, we have received 22,374 paper cases in 11 weeks. This totals 2,034 paper cases per week or 407 paper cases per day.

We are currently receiving 1,538 Direct and Expedited paper cases per week.

Problem: The 7 people performing DDE can only process 1,120 paper cases per week.

Solution: Rehire 4 DDE full-time temporary personnel. Now the DDE personnel equals 11. 11 people performing DDE can process 1,760 Direct and Expedited paper cases per week.

Problem: As a result of receiving ~3000 periodic paper cases, an increase in Direct and Expedited paper cases and the staff reduction, Pending + Pipeline increased to 8721.

Solution: Implement an Overtime Program.

The Overtime Program was a 6 week program that started on March 18, 2015 and ended on April 29, 2015.

Our Overtime goal was to reduce the Pipeline + Pending from 8,721 to 4,000.

Since starting overtime, we have reduced Pending from 4,746 to “0”.

Since starting overtime, we have reduced our Pipeline to 3,000.

Since starting overtime, all report types are currently in “real time”. Expedited paper and Direct cases have gone from 11 days processing to 7 days processing and Non-Expedited paper has gone from 88 days processing to 39 Days processing.

Report Tools Trouble Tickets

User Count Report: Closed ticket IM0444475 and track the problem with FAERS Defect 2571 – Open In the process of UAT Testing

Comparing our hand counts to their new report

Completed comparing New Case numbers - closed

Completed comparing DDE numbers - closed

Currently comparing Coding numbers - closed

Currently comparing Validation numbers - open eSUB Case Metric Report: CNI identified a bug in the report – Open In the process of UAT Testing

Comparing the number of electronic cases in Cases Logged report vs eSUB Case Metric report

Most importantly, comparing the number of electronic cases in the eSUB Case Metric report vs the number of Gateway files (Krishna’s count)

A new report will be created by CNI/OBI

(Various Interruptions)

6 MONTHS: There were approximately 53 hours of system interruptions for the past 6 months, that is equivalent to approximately 1,100 hours of production time lost.

We continue to fast track Code 24 reports (mifeprex) and Products of Concern (ex. Compounding Issues)

We continue to support and build the FAERS Product Dictionary

We continue to support and build the FAERS Manufacturer Dictionary

FAERS-DMP Tours continue on the 3rd Wednesday of each month 1 hour power point presentation by the PM

30 minute walk-thru and process demonstration tour by the PM

Standard Operating Procedures (SOPs) for FAERS is ongoing. Our tech writer, continues to work with CDER-FDA staff on writing the new FAERS SOP’s while at the same time assisting the FDA with 508 Compliance Documentation

Drug Quality Reporting System (DQRS) continues to achieve their target of maintaining the total unentered MedWatch reports below 50 under the guidance of Elise Murphy who is the DQA Branch Chief.

The DQAB has proposed an additional DSI personnel to triage incoming “Manufacturer Follow-up Letters” and forward the letters requiring follow up action to the DQAB. (Pilot project ongoing with a proposal as its deliverable)

The additional DSI personnel will also contact the MedWatch reporters by phone and/or email within 3 business days of receipt of report. DSI will notify the reporter that he/she is calling on behalf of FDA in order to receive more information on the MW that was submitted.

NDC number/Manufacturer Name

Lot number

PERFORMANCE AND STATISTICS

FAERS DMP DQRS

The statistics supplied are from January 1, 2014 to December 31, 2014 and with regard to the report types (MedWatch, FAR, etc.) the numbers are for completed cases into the database

Number of MedWatch reports completed – 4,812 Number of non-MedWatch reports completed:

Field Alert Reports (FAR) – 6,482 Biologic Product Deviation Reports (BPDR) – 75 Manufacturer follow-up reports completed: 1,929

Total for all report types completed in 2012 – 11,229 Total for all report types completed in 2013 - 12,440 (11% Increase) Total for all report types completed in 2014 – 13,298 (7% Increase)

Number of images/scanned pages – 15,578 Number of letters sent out – 4,675

FAERS PERFORMANCE TIMES

(As of September 2014)

In Seconds Average Processing Time over 10 Cases

Data Entry Processing

P ro c e s s in g

T im e i n

S e co n d s

Averaged Processing times

Expedited Direct New Case

Time to Open 4 4 4

Time to Save/Route 8 8 8

Time to Open Time to Save/Route

Expedited

Direct

New Case

Remember at the start of FAERS: Time to Open a case was 22sec. & Time to Save/Route a case was 56sec.

Electronic Submissions 2000 to 2014

In the last 2 years there has been a 34% Increase of new companies that have converted from paper to electronic submission.

Electronic Submissions 2000 to 2014

As of today (2015): That number (413) has been reduced to 289 companies. This represents a 30% reduction in paper submitters.

2014: Although 32 companies converted from paper to eSub, there were 413 companies still reporting via paper for a total of 64,866 paper case versions received

Electronic Submissions 2014

FAERS-DMP Statistics 2014

JAN 1, 2014 – DEC 31, 2014

Direct Paper – 34,246

Expedited Paper - 51,671

Non-Expedited Paper - 44,378

Expedited E2B - 746,634

Non-Expedited E2B - 423,850

Total 1,300,779

* Not Entered Into FAERS:

*Non-Serious Non NME Periodic cases - 84,433

*Direct cases entered into MEDEX, sorted to other Centers - 11,779 (46%Increase )

Overall Total - 1,396,991

As of 04/13/15: “0” Pending cases

130,295 Paper Cases Completed

130,295 Paper Cases Completed 117,239 Paper Cases Completed

In 2014 we completed 130,295 paper cases. This is the most paper cases completed since 2006.

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Total Cases 335,751 363,419 439,868 490,726 673,170 782,483 933,565 1,075,239 1,204,730 547,234

Non Expedited 95555 110,405 132,690 126,177 234,676 255,275 326,640 411,625 423,850 245,534

Expedited 219,217 229,982 274,282 330,384 409,548 499,156 577,892 635,228 746,634 289,922

Direct 20,979 23,032 32,896 34,165 28,946 28,052 29,033 28,386 34,246 11,778

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

C as e s

R e ce iv e d

2015 Projection for Total Cases Versions Received

Based upon the 547,234 total cases for the first quarter, we are projected to receive 1.6 million total cases for 2015

83% Electronic and 17% Paper

Expedited E2B 53%

Expedited Paper 4%

Periodic E2B 30%

Periodic Paper 3%

Direct Paper 3%

Non-Serious Non NME 6% CTU (Other than

CDER/CBER)

1%

After the E2B Mandation (After June 10, 2015)

History of Adverse Event Reporting

290,596

329,162

378,322 428,576

469,492 472,671

488,801 537,301

588,509

670,439

781,375

1,078,093

1,206,702 1,351,571

15,645 22,938 43,374

81,099

136,218 157,667

236,238

317,099

384,919

569,602

675,523

823,617

1,018,588

1,178,156

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Total # of Cases Versions rec'd

Total # of eSubs rec'd

15.87

14.55

14.11 12.73 11.77 11.69

8.93 8.58 8.81 6.77

4.64 4.64 3.26 3.71

76.3

73.8 72.7

63.2

52.8 52.3 51.4

47.5

41 41

50 50

Average Cost per Case

Average LOE(# of FTEs)

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Total # of Cases Versions rec'd 290,596 329,162 378,322 428,576 469,492 472,671 488,801 537,301 588,509 670,439 781,375 1,078,093 1,206,702 1,351,571

Total # of eSubs rec'd 15,645 22,938 43,374 81,099 136,218 157,667 236,238 317,099 384,919 569,602 675,523 823,617 1,018,588 1,178,156

Average Cost per Case $15.87 $14.55 $14.11 $12.73 $11.77 $11.69 $8.93 $8.58 $8.81 $6.77 $4.64 $4.64 $3.26 $3.71

Average LOE(# of FTEs) 79 76.3 73.8 72.7 69 63.2 52.8 52.3 51.4 47.5 41 41 50 50

Total Case Versions

Total eSubs

Average Cost

Per Case Version

T o ta l

F T

E s

A v e ra g e C o s t

P e r C a s e

V e rs io n

T o ta l N u m b e r o f

C a s e

V e rs io n s

FTEs

FAERS Paper vs Electronic January 2014 - December 2014

1,170,484

130,295 eSubs

Paper eSub Fallout

2%

90%

10%

23,410

Although Paper only accounts for 10% of all cases. It accounts for nearly 85% of the cost.

New Case can process 12 case per hour, billed rate 28.00 = 1 report $2.50 average

DDE can process 4 cases per hour, billed rate 28.00 = 1 report $7.00 average

Coding can process 8 cases per hour, billed rate 51.00 =1 report $6.30 average

Validation can process 8 cases per hour, billed rate 80.00 = 1 report $10.00 on average

$25.80 is the average cost for a paper report.

FAERS Paper vs Electronic Cost Breakdown January 2014 - December 2014

$142,009

$1,592,889

$410,973

Electronic

Paper eSub Fallout eSub Fallout

FAERS Operational Cost Breakdown by Processing Type

E2B

Paper

SUMMARY

FAERS 2014

SUMMARY

All Case Priority Paper and Electronic cases are being completed within the 7 Days contractual days processing goal.

In 2014 we completed 130,295 paper cases. This is the most paper cases completed since 2006.

In the last 2 years there has been a 34% increase of new companies that have converted from paper submission to electronic submission.

In 2015 we are projected to receive 1.6 million cases in FAERS.

Since starting the “Quality Enhancement Program” The Quarterly Data Extract results from the FDA have shown a 99.33% accuracy rate for Data Entry.

• A historical low 0.67% Data Entry error rate

Although paper only accounts for 10% of the total volume of reports received, it accounts for approximately 85% of the cost.