Download Pharmacovigilance Workshop II 20th June 2003 Medicines

Pharmacovigilance
Workshop II
20th June 2003
Medicines Regulation
Michael Bonett
Overview
• There is a need for collecting and evaluating data
relating to drug safety after licensing of the
medicinal product (Post-marketing)
• ADR reporting - most important source of Data
• Other sources of Data
• Signal generation and risk quantification
• Regulatory Action which can be taken
• Communication
Other Data Sources
• Pre-clinical data: in-vitro, animal toxicology
• Pre-authorisation information: generated between
the time of application and granting of license
• Pre-marketing clinical trails: reported by the
sponsor or investigator
• Reports received from the market authorisation
holder (MAH)
• Reports from worldwide scientific and medical
literature
Other Data Sources
• Data
transfer
from
ADR
databases:
from EU, World Health Organisation (WHO)
• Others: Consumers, patient organisations reports
• Periodic Safety Update Reports from MAH’s
• Company sponsored Post-Authorisation safety
studies
• Data from epidemiological studies and academic
centres
Signal Identification
• Signal: Data constituting a hypothesis that
may be relevant to the safe use of a drug
• Any amount of evidence giving rise to
further investigation is considered a signal
• To help identify signals computer generated
safety
monitoring
programmes
and
statistical methods are used
Signal Identification
Examples of signals:
•
•
•
•
Previously unidentified ADR’s
Change in reporting rate
Change in seriousness of reaction
Identification of new risk factors
for known ADR’s
Risk Quantification
Once a new signal is identified, the next step will be
to quantify:
• the strength of the association between the ADR and
the drug
• the frequency of occurrence
For this purpose:
• Reporting rate of ADR may be calculated
• MAH may perform epidemiological studies
Regulatory Action
• In many instances regulatory decisions have
to be taken promptly
• Based on evidence from all available data
• Experts and committees consulted
• The most appropriate action should be
chosen
Types of Regulatory Action
• Further investigation: more studies needed
• Update of product info to reflect new risk
• Restrictions: dose reduction, limitation of length
of use, restricting indications
• Suspension of indications
• Temporary suspension of market authorisation,
until further studies are conducted
• Withdrawal of the market authorisation
Communication
•
•
•
•
•
•
Market Authorisation Holders (MAH)
Other Regulatory Agencies
Healthcare Professionals
Patient Groups
General Public
Media
Communications
• Communication relating to the safety of
medicines has the potential to impact on the
general public, particularly if the safety issue
concerned has a broad public interest
• E.g. issues relating to the use of childhood
vaccines
• UK, media activity Re: MMR vaccine and
autism - MCA: ‘The evidence does not support
recent concerns’ - Confirmed safety of MMR
Conclusion
Collection of Data
Signal Identification
Risk Quantification
Regulatory Action
Communication of Safety information