MiDatabank ADR reporting
2016 update
2016 Highlights
• 3,574 Yellow Cards submitted via MiDatabank since 2011
• 2,282 (64%) reactions have been classed as serious
• 1,073 reports since summer 2015, that’s a 43% increase
• 15 new centres reporting since summer 2015
MiDatabank ADR reporting 2011 - 2016
Top 15 reporting units
August 2015 – June 2016
15 Centres reporting for the first time
since August 2015
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Addenbrooke's Hospital
Arbroath Infirmary
Central and NW London NHS Foundation Trust
Cheltenham General Hospital
Hillingdon Hospital
Lincoln County Hospital
Lister Hospital
Queen Elizabeth Hospital
Royal Brompton and Harefield NHS Trust
Royal Preston Hospital
Russells Hall Hospital
Sheffield Children's Hospital NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
University College London Hospitals NHS Foundation
Trust
• Wrexham Maelor Hospital
Hospital pharmacist reporting
An upward trend!
• The number of Yellow Cards received from hospital pharmacists has
almost tripled between 2011 and 2015.
• In 2015, hospital pharmacist Yellow Cards accounted for 16% of all
healthcare professional reports (2nd largest proportion)
• The majority of hospital pharmacist reporting is electronic, with 31%
reported directly via MiDatabank and 56% via the Yellow Card website
(www.mhra.gov.uk/yellowcard ).
• In 2015 hospital pharmacist electronic reporting increased by
approximately 40% compared to 2014.
• A huge ‘THANK YOU’ to all reporters for your contributions to the
Yellow Card Scheme – you are helping to make medicines safer.
Prepared by Christine Randall, North West Medicines Information Centre/Yellow Card Centre North West
Thank you to Mitul Jadeja, Alex Smith and Kendall Harrison, Medicines and Healthcare products Regulatory Agency for providing the data
MiDatabank ADR reporting
2016 update
Top 20 Drug/reaction combinations 2011 – 2016*
Drug Name
Omeprazole
Warfarin
Bendroflumethiazide
Aspirin
Sertraline
Flucloxacillin
Citalopram
Co-amoxiclav
Furosemide
Citalopram
Optiray
Amoxicillin
Aspirin
Warfarin
Aspirin
Aspirin
Bisoprolol
Lansoprazole
Warfarin
Furosemide
Reaction
Hyponatraemia
INR increased
Hyponatraemia
Melaena
Hyponatraemia
Diarrhoea
Hyponatraemia
Diarrhoea
Acute Kidney injury
ECG QT Prolonged
Rash
Diarrhoea
Haematemesis
Drug interaction
GI haemorrhage
Upper GI haemorrhage
Bradycardia
Hyponatraemia
GI haemorrhage
Hyponatraemia
MiDB reports
24
21
18
17
17
14
13
13
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12
12
11
11
11
10
10
10
10
10
9
*Excluding C.difficile reactions
The new Interactive Drug Analysis Profiles (iDAP)
Coming late 2016
Interactive Drug Analysis Profiles
(iDAPs)
Allows the user to display reports of suspected ADRs
• By age
• By sex
• By year of report
• By system organ class
Printer friendly reports available
What else is being reported via
MiDatabank?
New oral anticoagulants
160 reactions
Reactions not obviously related to thrombosis
or haemorrhage included:
• Dyspnoea (10)
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Dizziness (10)
Diarrhoea (9)
Paraesthesia (6)
Pain in extremity (6)
Fatigue (5)
Blurred vision (4)
Pruritis (4)
Eyelid/periorbital oedema (4)
Acute Kidney Injury
• 96 reports since 2011 (40 since August 2015)
• 142 suspected drugs, of these
 18 loop diuretics
 16 ACE inhibitors
 13 NSAIDs/aspirin
 20 antibiotics
• 8 trimethoprim
 7 spironolactone
 6 ARBs
Donepezil and QT
prolongation
Signal contribution from an
MiDatabank report
• EMA identified possible signal
• Company and member state s informed
• Signal review undertaken by MHRA using
Yellow Card reports
• MiDatabank report identified and included as
part of this review .
Have you downloaded the
Yellow Card app?
Download the app free via
iTunes Yellow Card for iOS
devices
PlayStore Yellow Card for
Android devices.
Prepared by Christine Randall, North West Medicines Information Centre/Yellow Card Centre North West
Thank you to to Mitul Jadeja, Alex Smith and Kendall Harrison, Medicines and Healthcare products Regulatory Agency for providing the data