challenges of effective safety messaging in the healthcare ... · dotarem gue gadovist magnevist...
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Challenges of effective safety messaging in the healthcare systemDr June RaineDirector, Vigilance and Risk Management of Medicines
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In this talk
Why need to strengthen safety messaging?
What are current challenges?
How move forward? Some examples
Where next - current opportunities?
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What is the MHRA’s role?
Availability of new treatments and technologies
Proactive vigilance and prompt risk management
Prompt information to healthcare professionals and patients on benefit risk change
Monitoring effectiveness of risk minimisation
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Why need for effective safety messaging?
Pirmohamed et al 2004 BMJ 329; 15-19
6.5% hospital admissions in UK relate to adverse drug reactionsADRs were responsible for death in 0.15%72% were classified as avoidable
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Today’s multiple safety messaging tools
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“Messages on safety are being compromised by the number of NHS central bodies and watchdogs issuing advice”
Sir Bruce Keogh 2017
Challenges for healthcare systems
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Range of potential target audiences
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Changing healthcare context
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HRT and increased risk of breast cancer
Monitoring outcomes of safety messaging
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Systems thinking
EducationImpact & outcomes
Today’s four safety messaging themes
Digital solutions
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Metal on Metal hip
NSAIDs-diclofenac
Gadolinium contrast agents
Four safety messaging examples
Sodium valproate
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Metal on metal hip replacements –soft tissue reactions
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Gadolinium contrast agents - risk of NSF Gadolinium-containing agents
UK Usage 2006 - 2010
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DOTAREM GUE GADOVIST MAGNEVIST PROHANCE MULTIHANCE PRIMOVIST OMNISCAN VASOVIST
MHRA Drug Safety Update
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NSAIDs and cardiovascular risk
Prescribing of NSAIDs
Hollingsbee et al 2011
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A Kearney et al. BMJ June 2006B MHRA Advice Oct 2006C MeReC Extra 30,Nov 2007D NPC workshops Feb‐Sept 08E Added into QoF
Prescribing of diclofenac as % total NSAIDs
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Sodium valproate – pregnancy exposure
Teratogenicity known since first licensing
Evidence accrues - 30-40% exposed children have developmental disorders
Further restrictions and strengthened warnings in product information in 2014
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MHRA Valproate Stakeholders Network
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Epilepsy
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Missing
Valproate use in women by indication
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Today’s opportunities
Integration of systems to facilitate risk management
Data sources & methodologies to measure impact
New digitally enabled communication tools
Increasing patient involvement in decisions
Developing partnership working between bodies
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Integration of adverse event reporting
Monthly webinar meetings to discuss reporting & safety attended by all UK countries
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Integrating medicines & medical devices vigilance
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Monitoring impact of safety messaging
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Yellow Card mobile app
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Professional bodies
Safety messaging partnerships
Devolved Governments
Clinical Guidelines
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Moving forwards
Co-ordinated synergistic safety messagingClarity of message and action to be taken
Targeted to right audienceUsing digital tools
Measurable public health protection