Transcript PowerPoint-presentatie

PharmacoVigilance:
Development of PhV
systems and processes
The goal of pharmacovigilance:

Systematic surveillance of all authorised veterinary medicinal
products

Ensure safe and effective products on the market
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Fast and proportional action on signals from data analysis
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Active crisis management with good and open communication
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Different levels of PhV systems
Estimate the need and expectation depending on
• Existing PhV system or starting new
• Financial and personnel resources
• Size of country or region
• Husbandry production and medicinal use
• Cooperation with other authorities
• Legislation
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Developing the PhV system
Steps
1. Draft legislation framework for PhV (avoid details)
2. Plan PhV-system in competent authority: responsibility, level of
ambition, cooperation in region, practical work, etc
3. Define responsibilities and obligations of companies
4. Consult draft plans with stakeholders – companies and vets
5. Establish necessary documentation and systems
• Reporting form for adverse events (AE)
• Filing system for AE-reports:
Paper  small electronic system  database
• Tools for analysis of data; signal detection; trend analysis; trigger thresholds
• Operating procedures
• Feedback communication
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Implementing the PhV system
• Communication and awareness plan
• Training?
• Make companies and vets aware of their obligations
• Set deadline for companies to implement in-house systems and procedures
(compliance)
• Spread the PhV-understanding to vets/users/owners
• Standard reporting form available on website, paper, by telephone, on
conferences, etc
• Start analysing across substances, products, species
• Consider using a risk-based approach, where the surveillance intensity is
proportional with the expected risk level
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1. PhV requirements in legislation
• Definitions of adverse events, scope of PhV, surveillance, timelines
~ (VICH GLs)
• Obligation for companies to
• receive AE-reports from vets/users/owners
• analyse the AE-reports and survey their products in general
• inform authorities.
• Possibility for authorities to
• inspect or control that companies comply
• analyse data from PhV or other sources
• take necessary actions based on PhV.
• Possibility/obligation for vets/users/owners to report directly to
authorities.
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2. Plan PhV-system in authority
• Define PhV-responsibility (who does what)
• Realistic ambitions
• Aim for regional cooperation if possible, because
• large-scale PhV-data are more useful and
• work-sharing between authorities is beneficial
• The company should be responsible for the PhV surveillance and
PhV reporting of their products
• The authority should perform controls and request corrective
actions
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The responsibility of the authority
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To establish a PhV system:
o collect information
o evaluate scientifically
o collate with data on use
o monitor compliance of companies
o do inspections
o take action
Initiate assessment of safety concerns
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Define risk management measures or implement conditions
and restrictions on products
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Encourage reporting of adverse events by vets/users/owners
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Communicate safety concerns and mitigation measures
Spread the PhV-understanding
Encourage reporting:
• Receipt letter to vets/users/owners, (and companies) who have
reported AEs
• Personal response to a few reporters if additional information is
needed
• Annual PhV-report in Vet magazine
• PhV-presentation for all graduating vets
• Education: module on PhV in vet university
• Ad-hoc presentations at vet conferences and Industry
association meetings
• AE-reporting form easily available
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Filing system for AE-reports
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From paper  small electronic system  database
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Simple (vet-specific) database with international compatibility is
preferable
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Tools for analysing data in the database are VERY important!
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There are hurdles for a large regional/international database, for
example:
• IT-compatibility for existing national databases
• Product database (same product with different names must be
”linked”)
• Who is responsible for analysing data
• ”Access to data”-agreements
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EU experience
Pharmacovigilance system based on
• Spontaneous reports
• PSURs – Periodic Safety Update Reports (defined reporting dates)
• Signal detection in database
• Follow-up and changes to product information when necessary
• PhV inspections
• Information to vets, users and owners about safe use of products,
which is what PhV is really about!
(footnote 2014: The EU legislation is currently under revision, also concerning
pharmacovigilance requirements)
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EU-Pharmacovigilance scope

Animal safety
• serious and non-serious adverse reactions
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Lack of expected efficacy
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Off-label use / misuse
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Humans reacting after exposure
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Violations of residue levels
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Potential environmental problems
Practical approach in national agency:
spontaneous AE-reports
Immediately after AE-report is received:
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case-number and letter of receipt
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causality assessment by Agency-vet
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decision on action/no-action, or request more information, etc
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PhV-report forwarded to Company
NB: Protection of personal data of reporter/owner may be
required
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Filing in national and/or in EU database (at EMA)
Practical approach in national agency:
PSURs
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Periodic safety update reports (PSURs) are received from the
companies in a periodic schedule, or on request
• includes all AE-reports and other PhV-information since last
PSUR and
• a benefit-risk evaluation for the product
• Received and assessed for national products
• Work share for EU-products (i.e. regional)
• Agreement on fixed data lock-points per substance
• Letter to company: OK, or occasionally changes in the product
information/leaflet, or further investigation requested.
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Minimal requirements of an AE report
• Identifiable reporter
• Animal (species)
• Suspected product
• Adverse event
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However, many more details are desired and possible
to fill in to the database/reporting form
Other PhV information exchange between
authorities
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Rapid Alert (EUDRANET = Secure intranet system
between all EU authorities): sent to all member
states, if urgent actions are needed
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Non-Urgent Information System: to share and
discuss specific trends or cases between member
states
Reference documents (EU)
• Regulation (EC) No 726/2004 (Title III Chapter 3) and
• Directive 2001/82/EC (Title VII)
• Volume 9 (b) – Guidelines on Pharmacovigilance for Medicinal
Products for Veterinary Use.
http://ec.europa.eu/health/files/eudralex/vol-9/vol_9b_201110.pdf
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(footnote 2014: The EU legislation is currently under revision, also concerning
pharmacovigilance requirements)