Drug Safety Monitoring in a Prepandemic and Pandemic Avian Flu Mass Vaccination Scenario
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1 Drug Safety Monitoring in a Prepandemic and Pandemic Avian Flu Mass Vaccination Scenario Andres Schneider Head Vigilance Unit Swiss Agency for Therapeutic Products
2 Background (1) The Swiss government has decided to offer prepandemic and pandemic avian flu vaccination to all inhabitants 8 million doses of prepandemic vaccine are stored Distribution during late prepandemic phase, within 4 weeks Swissmedic has to carry out drug safety surveillance even in case of a prepandemic and pandemic scenario Vaccination programmes are organized by the Cantonal Health Authorities
3 Background (2) Prepandemic Phases I-V: Daily business is running as usual, no restrictions Prepandemic vaccination programme causes workload peak at pharmacovigilance unit Pandemic Phase VI: Resources are reduced by at least 25% Working from home may be possible Second workload peak due to pandemic vaccination Resources at Swissmedic: Allow the processing of Adverse Drug Reaction reports per year
4 The Swiss Pharmacovigilance Network PHARMACEUTICAL INDUSTRY FOPH EKIF WHO PROGRAMME FOR INTERNATIONAL DRUG MONITORING GE PSYCH VD TERATO SWISSMEDIC PHARMACOVIGILANCE ZH TOX BS TI BE FOPH: Federal Office for Public Health EKIF: Eidgenössische Kommission für Impffragen
5 Challenges Avian flu vaccine contains a new adjuvans and influenza drugs may be used over a longer time period -> detection of new risks may require fast action Assumption: 1 ADR per 1000 vaccine doses: -> ADR reports to be expected within a few weeks Observation by other countries: -> no failure can be accepted Need for intensive and fast exchange of information: -> communication network must be installed beforehand
6 Swiss Concept Maintain the well accepted procedures for ADR reporting Points of contact and workflows are not changed Simplify and speed up the reporting Electronic reporting only by means of a self explaining webbased tool Reinforce the resources for data management and signals Regional pharmacovigilance centres: More manpower Contract with a CRO as call centre and for timely report handling Swissmedic to focus on signal detection and analysis Safety Board for signal evaluation Exchange of information on a daily basis FOPH / Safety Board: on the need for risk reducing measures Statistics about the vaccinated population (ADR incidences)
7 Status and Activities (1) Pandemic ADR database is ready Developed in collaboration with the WHO Uppsala Monitoring Centre Simplified online reporting form for primary reporters Signal detection and evaluation tool for Swissmedic Electronic data exchange with marketing authorization holders according to ICH Guideline E2B Collaboration with FOPH and other experts is established Section Pandemic Affairs Federal Commission for Vaccines Epidemiological studies with the prepandemic vaccine Small pilot study in 2008 ( ) Large cohort study in 2009 (>3 000)
8 Status and Activites (2) Database Refinements Language versions German, French, Italian Secure access Tool to gather demografic data about the vaccinated population Implementation of experiences from studies Development of the Info Concept Daily business Pandemic scenarios Staffing and Outsourcing Negotiation with CRO s and call centres
9
10 Proposals for Collaboration Between Countries Forum to exchange experiences from previous pandemics Update information about pandemic preparedness Database on safety and efficacy of pandemic medicines WHO / UMC Provide PaniFlow for ADR collection to all WHO member states (translation into local languages?) Provide common pandemic ADR database and signal detection tool Provide epidemiological data about rare diseases which may also be triggered by pandemic vaccination and other medicines
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