Pharmacovigilance An Overview

1
Pharmacovigilance An Overview

• Opportunities in Life Science Market

2
What is Pharmacovigilance?

• Proactive monitoring and reporting on the
  quality, safety and efficacy of drugs
• Assessment of the risks and benefits of marketed
  medicines
• Monitoring the impact of any corrective actions
  taken
• Providing information to consumers, practitioners
  and regulators on the effective use of drugs
• Designing programs and procedures for collecting
  and analyzing reports from patients and
  clinicians

3
Pharmacovigilance Why?

• At the time of approval, clinical trial data are
  available on limited numbers of patients treated
  for relatively short periods
• Once a product is marketed, large numbers of
  patients may be exposed, including
• Patients with co-morbid illnesses
• Patients using concomitant medications
• Patients with chronic exposure

4
Pharmacovigilance Why?

• After marketing, new safety information may
  become available
• Through use of the product domestically or in
  other countries
• Through use of other drugs in the same class
• From preclinical studies
• From pharmacologic studies
• From controlled clinical trials

5
What is a Safety Signal?

• An apparent excess of adverse events associated
  with use of a product
• Even a single well-documented case report may be
  viewed as a signal
• Preclinical findings or experience with other
  products in the class may be sufficient to
  generate a signal, even in the absence of case
  reports in patients
• A products risk profile may be characterized by
  several safety signals

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Safety Signals

• Are identified
• From case reports, other sources
• Are evaluated
• In pharmacoepidemiologic studies, registries,
  surveys
• Are interpreted
• In the context of all available safety
  information
• Are monitored
• Through enhanced pharmacovigilance efforts

7
Pharmacovigilance Plan

• A plan proposed by a sponsor
• for the ongoing evaluation of safety signals
  identified with the use of a product
• to monitor at-risk populations which have not
  been adequately studied
• Plan may be developed at the time of product
  launch or after a signal is identified
• A sponsors plan may involve
• Expedited reporting of serious adverse events of
  interest
• Submission of adverse event report summaries at
  more frequent, pre-specified intervals
• Conduct of additional observational studies or
  clinical trials
• Implementation of active surveillance activities
  to identify as yet unreported adverse events

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Active Surveillance

• Product-based activities
• Follow cohorts of patients exposed to specific
  products
• Setting-based activities
• Surveillance of healthcare settings (e.g., EDs)
  for events likely to present there
• Event-based activities
• Monitor registries for events that are often
  drug-related (e.g., liver transplant registries)

9
Opportunity

• Emerging new safety data may result in ongoing
  revisions to the sponsors pharmacovigilance plan
  for a product
• While additional safety information is being
  developed, the FDA will work with sponsors to
• communicate information about safety signals and
• minimize events occurring in users of a product
  through risk management programs

10
The Need

• Regulatory agencies are increasingly proactive in
  seeking out potential safety issues with marketed
  drugs - you must be ready to respond quickly
• Political and social pressures have increased
  along with faster communication channels
• Litigation due to the lack of pharmacovigilance
  can be devastating for all concerned
• Failure to practice pharmacovigilance can lead to
  the suspension or withdrawal of license

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Services

• Ensure compliance with regulatory requirements
  and activities, including safety surveillance,
  safety strategy, representation and communication
  with regulatory authorities
• Establish database systems and standard operating
  procedures (SOPs) for each product to be
  monitored
• Protocol design and implementation of
  post-authorization safety studies, as well as
  clinical assessment reports of completed studies.
  
• Stand-alone spontaneous report management
• Safety data management including MedDRA training
  and implementation
• Risk/Benefit assessment
• Review of safety systems and process, including
  full audits
• Safety reports
• Periodic Safety Update Reports (PSURs)
• Crisis management
• Risk management planning as advised by FDA