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Periodic Report Template Pharmacovigilance - PowerPoint by fpt11744

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Periodic Report Template Pharmacovigilance document sample

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									Pharmacovigilance for
 Licensed Products
      Sally Andrews
 Senior Chemist, Regulatory
  Affairs, Torbay Hospital
                     Content

•   Legal requirements
•   QP PV
•   ADR reporting/sources
•   Literature reviews
•   PSUR’s
•   Signal detection/ trending
•   Risk Management
•   PV inspections
                Definition
• The monitoring and management of the
  safety of a medicinal product, particularly
  after it has received a licence
• A system to collect, collate and evaluate
  information about suspected adverse drug
  reactions (ADR’s)
• Directive 2001/83/EC as amended;
  Volume 9A of the Rules Governing
  Medicinal Products in the EU
          Legal Requirements

•   PV system required for all authorisations
•   Detailed description
•   Roles of main parties
•   Proof of QP PV
•   Procedures
•   QMS :
    documentation/procedures/databases
                   QP PV
• Permanently and continuously at disposal of
  MAH
• Appropriately qualified
• 24 hour contact details
• Responsible for:
     - establishing and managing PV system
     - overview of safety issues/concerns
     - single contact point for MHRA
     - evaluation of risk/benefit of product
     - provision of information to MHRA
      ADR/ICSR Reporting (1)
• ADR - a response which is noxious and
  unintended that occurs at normal doses
• Serious ADR – a reaction resulting in death,
  hospitalisation, results in disability/ birth defect
  i.e. a medically significant reaction
• Minimum information required to report:
  - reporter ID
  - patient ID
  - drug/product involved
  - reaction description
     ADR/ICSR Reporting (2)
• All serious ADR’s must be reported as an
  expedited report
• 15 calendar days from receipt
• Validate ADR’s from healthcare
  professionals to ensure got all minimum
  information
• Non-serious ADR’s – not expedited but in
  next PSUR
     ADR/ICSR Reporting (3)
• Follow-up:
  - to acquire additional information to report
  to MHRA and medical confirmation
  - use of template proforma
  - pregnancy cases
  - overdose/misuse
  - obtain patient’s permission to contact GP
     ADR/ICSR Reporting (4)
• ADR Sources:
  - spontaneous: from healthcare
  professionals or patients (medical
  confirmation required)
  - literature: search of world wide scientific
  references databases
  - ASPR’s: received daily from MHRA (no
  need to report)
* Log all ADR’s on local database for review
        Literature Searches
• Maintain awareness of publications in
  world-wide scientific literature
• Review of databases e.g. Medline,
  Embase on a weekly basis
• Review publications for any ADR – main
  source
• Expedited reports within 15 days
• Part of Periodic Safety Update Report
  (PSUR)
              PSUR’s (1)
• Summary of analysis of safety data with
  evaluation of risk-benefit balance
• Legal requirement
• Frequency: every 6 months for first 2 yrs
                annually for 2 yrs
                3 yearly intervals
                immediately upon request
• Can lead to variation of licence, SPC, PIL
              PSUR’s (2)
• Licence renewals no effect on schedule
• Data lock points for time period
• Specified format (Volume 9A): individual
  cases, patient exposure, safety concerns,
  changes to SPC
• Review by clinician
• Approval by QP PV
    Signal Detection/ Trending
• Review sources of information for ADR’s –
  use of ADR database, Medical Information
  enquiries etc.
• Detect safety signal/trend
• Cumulative data set
• Clinician input for “medical significance”
• Signals referenced to SPC
    Risk Management System
• Required for new applications, where
  appropriate
• Discuss with MHRA on whether needed
• Benefits exceed risks
• Plan required: Safety specification
                 PV plan
                 Evaluation for minimising
                 risks, plan if required
              PV Inspections
•   Ensure MAH’s comply with legislation
•   Routine or targeted
•   2 yearly programme
•   Review of systems, personnel, facilities
•   Inspection report: findings as for GMP
•   Follow-up
•   Annual re-inspections for critical findings
                Summary
•   Legally required
•   Services of an appropriate QPPV
•   Identifying and reporting ADR’s
•   Undertake literature reviews
•   Preparation and submission of PSUR’s
•   Identifying safety signals/trends
•   Bi-annual inspections linked to GMP

								
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