FDA's Mini Sentinel Program to FDA s Mini Sentinel Program to - - PowerPoint PPT Presentation

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FDA's Mini Sentinel Program to FDA s Mini Sentinel Program to - - PowerPoint PPT Presentation

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FDA's Mini Sentinel Program to FDA s Mini Sentinel Program to Evaluate the Safety of Marketed Medical Products d l d Update and Focus on Communications Focus on Communications Richard Platt Harvard Pilgrim Health Care Institute Harvard

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FDA's Mini‐Sentinel Program to FDA s Mini Sentinel Program to Evaluate the Safety of Marketed d l d Medical Products Update and Focus on Communications Focus on Communications

Richard Platt

Harvard Pilgrim Health Care Institute Harvard Medical School

for the Mini‐Sentinel Investigators

info@mini‐sentinel.org 1

g

March 1, 2012

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Mini‐Sentinel

  • Develop scientific operations for active surveillance of

medical product safety medical product safety

  • Create a coordinating center with continuous access to

automated healthcare data systems, and the following y , g capabilities:

– Develop and evaluate scientific methods that might later be used in a fully‐operational Sentinel System. – Offer FDA the opportunity to evaluate safety issues in existing automated healthcare data system(s) and learn more about

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automated healthcare data system(s) and learn more about barriers and challenges.

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Mini‐Sentinel Partner Organizations Mini Sentinel Partner Organizations

info@mini‐sentinel.org 3

Institute for Health

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Mini‐Sentinel’s Evolving Common Data Model Mini Sentinel s Evolving Common Data Model

Administrative data from health plans Administrative data from health plans

  • Enrollment (start/stop dates, pharmacy coverage…)
  • Demographics (age, sex…)
  • Outpatient pharmacy dispensing
  • Utilization (encounters, diagnoses, procedures)

Electronic Health Record data from clinicians

  • Height, weight, blood pressure, temperature
  • Laboratory test results (selected tests)

Registries – public and private

info@mini‐sentinel.org 4

  • Immunization
  • Mortality (death and cause of death)
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The Mini‐Sentinel Distributed Database The Mini Sentinel Distributed Database

Populations with well‐defined periods for which Populations with well defined periods for which

medically‐attended events are known

126 million individuals* 3 billion dispensings

  • Accumulating 37 million dispensings per month

g p g p

2.4 billion encounters

  • Accumulating 41 million encounters per month
  • 40 million acute inpatient stays

13 million people with >1 laboratory test result

info@mini‐sentinel.org 5 *As of 12 December 2011. The potential for double‐counting exists if individuals moved between data partner health plans.

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Mini‐Sentinel Distributed Analysis Mini Sentinel Distributed Analysis

1‐ User creates and submits query (a computer program) (a computer program) 2‐ Data partners retrieve query 3‐ Data partners review and run query against their local data 4‐ Data partners review results 5‐ Data partners return results via secure network

info@mini‐sentinel.org 6

6 Results are aggregated

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Active surveillance: Active surveillance: actively assessing treatments & outcomes

Characterize treatments and health events For older products, assess concerns arising from any

source

For new products, monitor accumulating experience

for pre‐specified potential adverse outcomes

Assess impact of FDA actions

info@mini‐sentinel.org 7

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Rapid Queries of Exposures – Examples Rapid Queries of Exposures Examples

  • Drugs

Drugs

  • Analeptics, Analgesics, Antihypertensives, Antiarrhythmics,

Antiretrovirals, Antidepressants, Antipsychotics, Antibiotics, Bronchodilators, Cancer chemotherapy agents, Growth factor inhibitors, Intravenous iron, Smoking cessation drugs, Steroids g g ,

  • Vaccines
  • Measles/mumps/rubella, rotavirus, human papilloma virus

p p p

  • Devices
  • Hip replacement, Negative pressure wound therapy devices

info@mini‐sentinel.org 8

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Rapid Queries of Health Events – Examples Rapid Queries of Health Events Examples

  • Cardiovascular: Acute myocardial infarction,

Cardiovascular: Acute myocardial infarction, Hyperlipidemia

  • Neurologic: Parkinson’s disease,

g , Progressive multi‐focal leukoencephalopathy

  • Gastrointestinal: Celiac disease, Ulcerative colitis,

Crohn’s disease

  • Allergic: Severe cutaneous conditions, Anaphylaxis,

Angioedema, Milk allergy

  • Other: Osteonecrosis of the jaw

info@mini‐sentinel.org 9

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Rapid Queries of Exposure‐Outcome Pairs Rapid Queries of Exposure Outcome Pairs

  • Angiotensin receptor blockers (ARBs) and celiac disease
  • Drugs for smoking cessation and cardiac outcomes
  • Drugs for smoking cessation and cardiac outcomes
  • Drugs for Parkinson's disease and acute myocardial

infarction or stroke infarction or stroke

  • Analeptics and severe cutaneous adverse reactions
  • Drugs for diabetes and hypersensitivity reactions
  • Atypical antipsychotics and hypersensitivity reactions
  • Vascular endothelial growth factor inhibitors and

t i f th j

  • steonecrosis of the jaw
  • Direct thrombin inhibitors / warfarin and bleeding
  • Aspirin antagonists and stroke or transient ischemic

info@mini‐sentinel.org 10

Aspirin antagonists and stroke or transient ischemic attack

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ARBs and celiac disease ARBs and celiac disease

Potential signal identified in AERS database Potential signal identified in AERS database Review of cases inconclusive

info@mini‐sentinel.org 11

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ARBs and celiac disease ARBs and celiac disease

0.070 0.080 rs 0.050 0.060 erson year 0.030 0.040 s per 100 p 0 000 0.010 0.020 Cases 0.000 LOSARTAN IRBESARTAN OLMESARTAN TELMISARTAN VALSARTAN Cases 63 10 17 5 50 N 235 630 40 071 81 560 24 596 153 159

info@mini‐sentinel.org 12

New users 235,630 40,071 81,560 24,596 153,159

ARBs: New users after >365 day washout; Celiac Disease: 1st dx code after >365 day without diagnosis.

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Limitations Limitations

Capture of relevant gastro‐intestinal events may be Capture of relevant gastro intestinal events may be

incomplete

Potential inclusion of irrelevant events Patients exposed to different agents may differ with

respect to risk of symptoms

M j

it f li it d t f th

Majority of exposures limited to a few months

duration

Lack of observed risk doesn’t rule out an excess Lack of observed risk doesn’t rule out an excess

info@mini‐sentinel.org 13

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ARBs and celiac disease – documentation ARBs and celiac disease documentation

info@mini‐sentinel.org 14

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One‐Time Protocol‐based Assessments One Time Protocol based Assessments

Rotavirus Vaccines and Intussusception Rotavirus Vaccines and Intussusception Influenza Vaccine and Febrile Seizures Influenza Vaccine and Pregnancy Outcomes Influenza Vaccine and Pregnancy Outcomes Human papilloma virus vaccine and

Venous Thromboembolism Venous Thromboembolism

ACEIs/ARBs/aliskiren and Angioedema Aripiprazole and Venous Thromboembolism Aripiprazole and Venous Thromboembolism

info@mini‐sentinel.org 15

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Prospective surveillance: p Antidiabetic Drugs and Acute MI

Repeated evaluation of acute MI risk in new users of

saxagliptin vs. comparator antidiabetic drugs

Case mix adjustment via disease risk scores and

propensity scores

280,745 eligible new users Aug, 2009 – Dec, 2010:

Antidiabetic drug New users Saxagliptin 5,877 Sit li ti 31 425 Sitagliptin 31,425 Pioglitazone 55,134 Long acting insulin 72 024

info@mini‐sentinel.org 16

Long‐acting insulin 72,024 2nd generation sulfonylureas 116,285

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Assessments of FDA’s Regulatory Actions g y

Long Acting Beta Agonists g g g Objective: Evaluate the impact of labeling change advising j p g g g against long term use of LABAs as a single agent on changes in use and health outcomes of interest Status: Workgroup developing protocol

info@mini‐sentinel.org 17

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Challenges Challenges

Many different exposures Many different outcomes Many patient types Many and diverse data environments Need for timeliness in both detection and followup Need to avoid false alarms

Need to avoid false alarms

Need for multiple simultaneous activities Need for surge capacity

info@mini‐sentinel.org 18

Need for surge capacity

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info@mini‐sentinel.org 19

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info@mini‐sentinel.org 20

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info@mini‐sentinel.org 21

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info@mini‐sentinel.org 22

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ARBs and celiac disease ARBs and celiac disease

info@mini‐sentinel.org 23

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info@mini‐sentinel.org 24

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Mini‐Sentinel Journal Supplement Mini Sentinel Journal Supplement

  • Supplement to

Pharmacoepidemiology and Drug Safety

  • 34 peer reviewed articles;

303 pages 303 pages

  • Goals, organization, privacy

policy, data systems, systematic reviews, stats/epi methods, record retrieval and review, protocols for and review, protocols for drug/vaccine studies...

  • Open access!

info@mini‐sentinel.org 27

  • http://onlinelibrary.wiley.com/doi/

10.1002/pds.v21.S1/issuetoc

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info@mini‐sentinel.org 28

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Thank you!

info@mini‐sentinel.org 29