Adverse Event Detection in the Pharmaceutical Industry

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Adverse Event Detection in the Pharmaceutical
Industry

• Leo Dodds,
• Director, Customer Communication Center,
  Ortho-McNeil Janssen Scientific Affairs, LLC

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Our Focus today
Todays discussion will focus on the Adverse
Event process within the pharmaceutical industry

• We will cover
• Why are Adverse Events so important for
  Pharmaceutical companies to track?
• What do our responsibilities include?
• What is our process?
• What tools do we employ?
• What skills must we possess?

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• A Spontaneous Adverse Event (AE)
• Is any untoward medical occurrence in a patient
  treated with a pharmaceutical product
• Does not necessarily have a causal relationship
  with the treatment

• Adverse Events may include
• Suspected drug interactions
• Product quality complaints (PQCs), drug errors,
  or drug abuse
• Events resulting from overdoses
• Congenital anomalies/ events after pregnancy
• Lack of efficacy
• Worsening of underlying disease/ illness with the
  use of a drug
• Drug effects other than that which is intended

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Why does Pharma take AEs so seriously?

• Patient safety and well being are the primary
  drivers behind every decision in taken in our
  business. Together, they govern every aspect of
  our planning, activity, and communication.
• There are clear federal and international
  regulations requiring Pharma to track and report
  AEs and PQCs
• Monitoring reports helps to drive continual
  improvement in our products, their side effect
  profiles and our delivery systems

Because its the right thing to do
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Our responsibilities include

• Collect information on AEs and case reports of
  pregnancy from all sources
• Identify adverse drug reactions/ safety signals
• Analyze information in an unbiased manner
• Report individual cases to the regulatory
  authorities
• Provide regulatory authorities with periodic
  summary reports
• Update prescribing information (data sheets) and
  investigator brochures

Communicate
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Example of PV Form
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What rules govern AE capture and reporting?

• Mandatory Reporting (Manufacturers)
• Serious 15 days
• Non-Serious Quarterly, for new products
• Annual, thereafter
• Internal Reporting (to our Safety Group)
• Serious 3 days
• Non-serious 5 days

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Defining Our Approach to AE collection

• We strive to ensure that we have processes and
  tools which
• Maximize our opportunity to capture AEs/PQCs,
  and
• Work to ensure complete and accurate capture of
  details
• We accomplish this through our
• Process (streamlined and efficient)
• People (training and experience)
• Tools (integrated and validated)
• Activities (timely and compliant)

Our technology, training and activities are
process-driven
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Our Process

• Seibel
• GCRS
• PQMS

• Distribution lists
• Websites

• SCEPTRE
• ACHIMEDES

Tools

• Probe to verify
• Capture all elements
• Check for secondary AEs
• System is validated

• Case processing and reporting
• Compliance tracking
• Signal detection/labeling
• Product issue mgmt
• PQC complaints

• Worldwide Regulatory health authorities
• Licensing partners
• Worldwide Operating Companies

Key Steps/Points
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Our People
Product training Adverse Event detection
training SOP training System training
Medical professionals Continual
re-certification
Disease state, clinical studies, package insert
For every employee, and for anyone, including
contractors, who come into contact with
public 20 SOPs and WIs Entry, reporting,
monitoring Certified RNs, PharmDs,
MDs Conducted annually and monitored for
compliance
Front Line team members receive 4-6 weeks of
training before receiving any contact center calls
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Our Tools AE capture

• One long web page for easier data entry
• Shortcuts on the left to jump to specific
  sections of the form
• Fully validated and integrated with other
  applications

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Our Tools Quality Monitoring system

• We monitor contact center screen capture and
  audio
• We evaluate analysts on call management, product
  knowledge, and system navigation
• Evaluations lead to individual coaching and
  learning programs

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Our Activities

• Quality Assurance monitoring
• Monitoring call management and data capture
• Compliance Monitoring
• Reporting timelines
• Completeness of AE reports
• Metric gathering
• Measuring intervals of time regarding the
  collection, processing and reporting of AE
  reports
• Mitigating Business Risk through continual
  improvement
• Continually refining process and to improve
  integrity and reduce reporting errors leading to
  improved patient safety
• Managing audits
• Documentation of processes
• Monitoring adherence to approved procedures

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Benefits

• Drive continual improvements in both collection
  and reporting
• Increases data integrity and completeness
• Reduces handovers
• Facilitates analysis and issue detection
• Streamline internal operations through
  standardizing and simplifying key processes
• Harmonize process across all JJ
• Eliminate non-compliant AE supplier systems
• Improved consistency
• JJ physical paper reduction (AE processing was
  in excess of 3.5 million sheets of paper)
• Continue to protect the integrity and reputation
  of JJ through robust compliance and PV programs
• Central Inbound reporting Unit co-located with
  case processing and data cleaning units
• Increased compliance
• Dedicated resource, single reporting structure
  makes it scalable to demand