pharmacovigilance€¦ · priya bahri: pharmacovigilance • adverse reactions (side effects), inc....
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An agency of the European Union Presented by: Priya Bahri
Pharmacovigilance Training session for patients and consumers involved in EMA activities, 10 December 2013
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Priya Bahri: Pharmacovigilance 4
Pharmacovigilance
as the science concerned with the risks of medicines
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Priya Bahri: Pharmacovigilance 5
• Adverse reactions (side effects), inc. toxicity for unborn child, non-fitness to drive • Overdose, misuse and abuse • Off-label use (use not as authorised) • Medication errors • Quality defects • Counterfeits • Lack of efficacy • Underuse due to public scare
Risks with medicines endangering patient and/or public health
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Priya Bahri: Pharmacovigilance 6
• Harm or potential for harm? • Identified and potential risks = “known knowns” and “known unknowns” – Cave: “unknowns unknowns” • Probability and frequency -> Quantitative risk measures • Multifactorial -> Qualitative aspects and risk factors • Serious and non-serious
What is risk?
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Priya Bahri: Pharmacovigilance 7
• Relative risk = Multiplicative factor, applied to a reference risk for an occurrence, associated with an exposure in a population • Absolute risk = Number of exposed persons experiencing an occurrence (adding the risk for this population had it not been exposed and the risk induced by the exposure(=background risk))
Quantitative risk measures
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= An important identified risk, important potential risk or missing information
Safety concern
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Priya Bahri: Pharmacovigilance 9
= Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action
Signal
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Priya Bahri: Pharmacovigilance 10
= Response to a suspected medicinal product which is noxious and unintended Reaction means that it is thought to be not just a coincidental event but that a causal relationship is suspected.
Adverse reaction
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Priya Bahri: Pharmacovigilance 11
= An adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect
Serious adverse reaction
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Priya Bahri: Pharmacovigilance 12
• Very common: > 1/10 • Common: > 1/100 to < 1/10 • Uncommon: > 1/1000 to < 1/100 • Rare: > 1/10000 to < 1/1000 • Very rare: < 1/10000
Frequency categories for adverse reactions
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Priya Bahri: Pharmacovigilance 16
= Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
Pharmacovigilance
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Priya Bahri: Pharmacovigilance 17
• Wider use in different population • Other risk factors • Healthcare practice
Clinical trials are small and controlled and hence do not allow for identifying all risks prior to marketing authorisation.
Pharmacovigilance post-authorisation – Why?
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Priya Bahri: Pharmacovigilance 18
• Data collection • Data analysis / Identification of safety concerns and signals • Risk assessment and assessment of benefit-risk balance • Option analysis and decision-making on risk minimisation / regulatory action • Communication • Evaluation of the effectiveness of risk minimising action
Pharmacovigilance work flow
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• Spontaneous reporting of adverse reactions
• Additional monitoring
• Post-authorisation safety and other studies
• Signal management
• Periodic safety update reports
• Risk management plans
• Incident management
• Continuous conduct of pharmacovigilance and monitoring/evaluation of benefit-
risk balance
Pharmacovigilance tools and processes 1/2
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Priya Bahri: Pharmacovigilance 20
• Public participation and hearings
• Safety communication
• International collaboration
• Pharmacovigilance systems with quality management, master files
• Audits and inspections
Pharmacovigilance tools and processes 2/2
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Priya Bahri: Pharmacovigilance Priya Bahri: 21
= An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organisation (e.g. the World Health Organization, a regional centre, a poison control centre) that describes one or more adverse reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organised data collection scheme
Spontaneous report
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Priya Bahri: Pharmacovigilance Priya Bahri: 22
To enhance spontaneous reporting by an inverted triangle and encouraging text in the product information
Additional monitoring
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Priya Bahri: Pharmacovigilance Priya Bahri: 23
= Format and content for the reporting of one or several suspected adverse reactions to a medicinal product that occur in a single patient at a specific point of time
Individual case safety report (ICSR) synonym: Adverse (drug) reaction report
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Priya Bahri: Pharmacovigilance Priya Bahri 24
= Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures May be an interventional clinical trial or may follow an observational, non-interventional study design
Post-authorisation safety study (PASS)
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Priya Bahri: Pharmacovigilance Priya Bahri 25
= Signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action
Signal management
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Priya Bahri: Pharmacovigilance Priya Bahri 26
= Format and content for providing an evaluation of the risk-benefit balance of a medicinal product for submission by the marketing authorisation holder at defined time points during the post-authorisation phase • To present a comprehensive and critical analysis of
the risk-benefit balance taking into account new information in the context of cumulative data
• Assessed to determine whether there are new risks or whether risks have changed or whether there are changes to the risk-benefit balance
Periodic safety update report (PSUR)
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Priya Bahri: Pharmacovigilance Priya Bahri: 27
= A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those interventions Risk management plan (RMP):
A detailed description of the risk management system
Risk management system
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Priya Bahri: Pharmacovigilance Priya Bahri 28
= A situation where an event occurs or new information arises, irrespective whether this is in the public domain or not, in relation to (an) authorised medicinal product(s) which could have a serious impact on public health
Incident
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Priya Bahri: Pharmacovigilance Priya Bahri: 29
• Raison d’être! • User of information for safe use of medicine • Regulatory review of product information and safety announcements • Spontaneous reporting • Study participant • Provide information, e.g. at public hearings • Patient expert at regulatory fora
Patients’ role in pharmacovigilance
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Priya Bahri: Pharmacovigilance Priya Bahri: 30
= Committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines -> Comments from Albert van der Zijeden
Pharmacovigilance Risk Assessment Committee (PRAC)
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