Yellow Card Scheme Flashcards
What situations must we report of Yellow Card Scheme? (3)
MHRA = Medicines and Health products Regulatory Agency
- serious suspected adverse reactions to all medicines
- all reactions to products marked with a Black Triangle in BNF
- adverse incidents - involving medical devices, including those caused by human errors - these that have the potential to put healthcare professional/patient safety at risk
Adverse Drug Reaction vs Side effect
- ADR - unpleasant, unintended
- Side effect - may be beneficial as well as harmful*
*e.g. Sildenafil (Viagra) initially cause the development of hypertension but licensed for erectile dysfunction
Examples of common, but not a serious side effect?
- cough with ACE inhibitors
- constipation with opioids
- nausea when starting SSRIs
- diarrhoea with antibiotics
- rash with penicillin
What rash may develop due to Penicillin?
What drugs may cause Achilles Tendonitis as their side effect?
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin)
*uncommon but well- recognised ADR
What is uncommon, but a well-recognised side effect of statins?
Rhabdomyolysis
What drugs may cause Toxic Epidermal Necrolysis (TEN)?
Anticonvulsants
*uncommon, but well recognised side effect
What is an uncommon, but well-recognised side effect of diuretics?
AKI
What antibiotics may cause cholestatic jaundice?
Flucloxacillin and co-amoxiclav
*uncommon but well recognised ADR
Who is most at risk of ADRs?
- elderly
- children
- females
- co-existing diseases
- atopic individuals
- polypharmacy
What are the factors that could raise our suspicion of that particular drug causing ADR?
Appears soon / when:
- a dosage increases
- new drug is started
Disappears when: the drug is stopped
Reappears when: a drug is restarted (do not rechallenge!)
What does the Black Triangle after the name of the drug mean?
- indicates that the medication is new to the market
OR
- an existing medicine (or vaccine) is being used for a new reason or by a new route of administration
- highlights the need for surveillance of any ADRs that might arise from the use of a new medication (especially when newly introduced to widespread group)
What is a rare ACR related to ACE inhibitors?
ACE inhibitor-related angioedema
- in 40% it has a delayed onset (weeks, months or years after strting)
- intermitted presentation
*if patient suppers angioedema -> all ACE inhibitors are contraindicated
What’s the purpose of reporting ADR via Yellow Card Scheme?
- to report ADRs that are not identified in clinical trials
- to identify new ADRs ASAP
What is a serious reaction?
Serious reaction = reaction that is:
- life-threatening
- disabling/incapacitating
- results in a prolonged hospital stay
- results congenital abnormality
- medically significant
Just have a look at that flashcard (examples of serious ADR)
What are the modes that we can use the Yellow Card by?
- app
- online
- paper
What information is needed (4) to report on Yellow Scheme Card?
- patient details (anomynasised: initials used, but weight, height, gender and age indicated)
- suspect drug
- suspect reaction
- reporter details
Examples of reaction to ‘Spice’
‘Spice’ = synthetic cannabinoid
*usually reported by A&Es
- decreased motor coordination (39%)
- fast or irregular heartbeat (33%) •
- dissociation (22%)
- dizziness (20%)
- paranoia (18%)
- pychosis (4%)
What is (1) serious ADR of Onivyde?
Onivyde - it is irinotecan, liposome injection
*used to treat colon cancer or small cell lung cancer
Serious/ fatal thromboembolic events
