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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5,000

10,000

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20,000

25,000

30,000

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Q12006

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Q12007

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Quarter

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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

15

0

10

20

30

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Dec‐05

Mar‐06

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%

EAST MIDLANDS

EAST OF ENGLAND

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NORTH EAST

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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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18

MHRA Valproate Stakeholders Network

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Rat

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6 month time period

Epilepsy

Bipolar

Migraine

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