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A presentation by Dr. John Clark, President and Chief Medical Officer at PCSglobal, on European pharmacovigilance issues presented at the 2013 Regulatory Affairs Professional Society Annual Meeting. Major issues and challenges posed by EU (European Union) Regulations are covered in this presentation.
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Regulatory Affairs Professional Society 2013 Annual Meeting September 30, 2013
John A. Clark, MD, MSPH President and Chief Medical Officer
PCSglobal
The New European PV Legislation: Issues and Challenges
PRIMARY PHARMACOVIGILANCE SYSTEMS
l Expedited adverse event case reports l Signaling and surveillance l Benefit-risk evaluations l Risk management
Medical Product Safety Safety-Related Information Systems
What are the major issues?
Safety-Related Information Systems Issues and Challenges Posed by EU Regulations
What are the biggest challenges?
SYSTEM ATTRIBUTES
l Purpose: identify ADRs with emphasis on unexpected, serious
l Product specificity: non-specific l Information unit: single patient adverse
experience(s) l Basic approach: medical interpretation of
cases l Typical analyses: individual case causality
analysis, review of line listings l Focus: risk
Safety-Related Information Systems Expedited Adverse Event Case Reports
ISSUES
l Enlargement of ADR definitions – Global safety experiences – All conditions of use – All reporting environments – All reporters
l Integration of medical services’ and manufacturer’s data systems – Messaging structures – Product and event dictionaries
Safety-Related Information Systems Expedited Adverse Event Case Reports
CHALLENGES
l Increased operational complexity – Comprehensive ADR capture – Increased scope of ADR – Processing timelines
l Integration of medical services data structures into case report systems – Electronic reports (ICH-E2B versus HL7 ICSR) – Event dictionaries (e.g., MedDRA, SNOMED versus ICD-10, LOINC)
Safety-Related Information Systems Expedited Adverse Event Case Reports
SYSTEM ATTRIBUTES
l Purpose: find safety issues that are unknown or incompletely understood
l Product specificity: both specific and non-specific l Information unit: exposed case series l Basic approach: exposed/control group
comparisons l Typical analyses: increased frequency
assessment, surveillance observed to expected, case-control study, cohort study
l Focus: risk, strength of association, risk factors
Safety-Related Information Systems Signaling and Surveillance
ISSUES
l Signals from non-interventional studies – Defining and retrieving NI studies – Large number of NI studies now published
every year l Rapid signal work-ups l Signal tracking l Signal escalation
Safety-Related Information Systems Signaling and Surveillance
CHALLENGES
l Finding, assessing, and triaging NI study evidence – Retrieval definitions – Impact of results, data quality – Selection of studies as safety signals – Archiving of NI study results
l Signal evaluation software l Inter-departmental linkage of signals l Signal escalation in outsourced environments
Safety-Related Information Systems Signaling and Surveillance
SYSTEM ATTRIBUTES
l Purpose: evaluate known benefits and risks of a healthcare product versus a standard
l Product specificity: mostly product specific l Information unit: endpoint comparisons
(efficacy, effectiveness, and risk) l Basic approach: weighted comparison of
aggregate benefits versus aggregate risks l Typical analyses: Variants of multiple
criteria decision analysis (MCDA) l Focus: benefit:risk balance
Safety-Related Information Systems Benefit-Risk Evaluations
ISSUES
l Integration of BRE processes into existing operations
l Design of BRE “calculator” – Formal MCDA modeling versus rule-based – Defining axes and units (scalar, categorical)
l Determining risk management responses l Trend toward products with complex
manufacturing requirements
Safety-Related Information Systems Benefit-Risk Evaluations
CHALLENGES
l Personnel/teams with wide range of analytical skills
l Process redesign l New kinds of modeling and technology l Information acquisition, transfer, and
visualization
Safety-Related Information Systems Benefit-Risk Evaluations
SYSTEM ATTRIBUTES
l Purposes: maximize benefits, minimize risks l Product specificity: entirely product specific l Information unit: time dependent
measurements of key processes/outcomes l Basic approach: key variable trend analyses l Typical analyses: rate trending, surveys,
audits l Focus: optimization of benefit:risk in target
and non-target populations
Safety-Related Information Systems Risk Management
ISSUES
l Assuring data integrity l Measuring program effectiveness
– Target population specificity (includes off label use)
– Ongoing, rather than intermittent l Focus on medication errors and
product monitoring l Increasingly complex tool kit l Implementation in multiple territories
Safety-Related Information Systems Risk Management
CHALLENGES
l Teams with broad range of skills l Assessing non-routine information l Measuring effectiveness:
– Outcome (versus process) variables – Medical services activities
l Integration of data arising from: – Real time timelines – Point of use in services organizations – Multiple countries
Safety-Related Information Systems Risk Management
John Clark, MD, MSPH PCSglobal
740 Bethlehem Pike Flourtown, PA 19034
(215) 510-4737 [email protected]
