Yellow card scheme Flashcards

1
Q

Adverse drug reaction

A
  • Response to a medicinal product
    which is noxious and unintended
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2
Q

How does an ADR arise

A
  • Use of a product within or outside the terms of the marketing
    authorisation, e.g. from off-label use,
    medication errors, overdose, misuse, or abuse
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3
Q

What can an ADR cause

A
  • Adversely affect patient compliance
  • Reduce available choice of drug treatment
  • Reduce potential efficacy of drug treatment
  • Reduce quality of life
  • Cause diagnostic confusion
  • Reduce a patient’s confidence in their healthcare
    professional
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4
Q

Common ADRs A type

A
  • Predictable - Bracycardia when using beta blockers
  • Can be reversed by reducing drug
  • NSAIDS
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5
Q

Type B ADR

A
  • Unpleasent and not dose realated
  • Severe and fatal
  • Achilles tendonitis caused by quinonlone antibiotic
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6
Q

Type C ADR

A
  • Reactions that occour after taking a drug for a long time
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7
Q

Type D ADR

A
  • Drug induced cancers
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8
Q

Type E ADR

A
  • End of treatment effects withrawal from opiates
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9
Q

DoTS

A
  • Dose time and susceptibility
  • At doses below therapeutic doses
  • Anaphylaxis with penicillin
  • In the therapeutic dose range
  • Nausea with morphine
  • At high doses
  • Liver failure with paracetamo
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10
Q

Onset characteristics of ADR

A
  • With the first or second dose
  • Anaphylaxis with penicillin as it occours early, or after a time, or with long-term treatment
  • First few days: nitrate induced headache
  • Peptic ulcer with NSAIDs
  • Several weeks: drug-induced Cushing’s syndrome
  • On stopping treatment opiate withdrawal syndrome
  • Delayed drug induced cancer
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11
Q

Suceptability of patients

A
  • Genetics - Greek and African origin are more likely
    to experience breathing problems with codeine
  • Age – parkinsonism with metoclopramide in
    adolescents
  • Sex – ACE-inhibitor induced cough more likely in
    women
  • Physiological state – phenytoin in pregnancy
  • Exogenous drugs or foods – warfarin, cranberry
    juice, and increased INR
  • Disease – gentamicin & deafness in renal failure
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12
Q

High risk population

A
  • Dose related to height and weight able to identify potential error
  • Older has Co-morbidities, Polypharmacy, Diminished reserve and Reduced renal or hepatic function
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13
Q

Indicate an ADR

A
  • Abnormal clinical measurement temperature pulse and blood glucose and lab results
  • New therapy which may mask an ADR
  • Reducing and stopping dose stopping the suspected drug
  • Listen to patient
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14
Q

How to avoid ADRs

A
  • Avoid uncecessary drug usage
  • Reduced drug action
  • Avoid new drugs such as black triangle drugs
  • Patient councelling
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15
Q

Pharmacovigilance

A
  • Important role in patient
    safety
  • Detecting adverse drug reaction
  • Continued saftety monitoring
  • New drugs are less safe as there is a lack of experiance
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16
Q

Why ADR should you report ADR

A

For a reaction occurring in 1 in 10, 000 people ≥30,000 patients need to be exposed to detect it with certainty

17
Q

Yellow card scheme

A
  • Recieves reports of suspected adverse reactions
  • Acts as an early warning system to identify ADRs and risk factors
18
Q

Black triangle drug

A
  • Report all suspected ADRs for new drugs
  • Drug that under intensive monitoring
  • New drugs, combinations to drugs routes and delivery systems
19
Q

MHRA reporting if

A
  • Fatal
  • Life threatening
  • Disabling
  • Prolong hospitalisation
20
Q

How do you report?

A
  • Fill in a paper copy FREEPOST address
  • Yellow card app that shows drug prints analysis
21
Q

Jouney of yellow card

A
  • Comes into Database
  • Processing quality assurance takes 48-72 hours
22
Q

Signal detection

A
  • Signal detections meeting
  • Data gathering
  • Signal evaluation then action
23
Q

Actions taken

A
  • Change in legal status
  • Restrict pack size
  • Update patient leaflets and prescribing information to include new side effects
  • Restrict indications, reduce dose or introduce new warnings for use
24
Q

Letting people know

A
  • Central Alerting System
  • Drug Safety Update (monthly)
  • Dear Healthcare Professional letters
  • Updated product information (PIL and SPC)
  • BNF safety warnings
  • Targeted information for patients and working
    with stakeholders
  • Social Media