Yellow Card Scheme

Question 1

What situations must we report of Yellow Card Scheme? (3)

Answer 1

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

Question 2

Adverse Drug Reaction vs Side effect

Answer 2

• 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

Question 3

Examples of common, but not a serious side effect?

Answer 3

• cough with ACE inhibitors
• constipation with opioids
• nausea when starting SSRIs
• diarrhoea with antibiotics
• rash with penicillin

Question 4

What rash may develop due to Penicillin?

Answer 4

Question 5

What drugs may cause Achilles Tendonitis as their side effect?

Answer 5

Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin)

*uncommon but well- recognised ADR

Question 6

What is uncommon, but a well-recognised side effect of statins?

Answer 6

Rhabdomyolysis

Question 7

What drugs may cause Toxic Epidermal Necrolysis (TEN)?

Answer 7

Anticonvulsants

*uncommon, but well recognised side effect

Question 8

What is an uncommon, but well-recognised side effect of diuretics?

Answer 8

AKI

Question 9

What antibiotics may cause cholestatic jaundice?

Answer 9

Flucloxacillin and co-amoxiclav

*uncommon but well recognised ADR

Question 10

Who is most at risk of ADRs?

Answer 10

• elderly
• children
• females
• co-existing diseases
• atopic individuals
• polypharmacy

Question 11

What are the factors that could raise our suspicion of that particular drug causing ADR?

Answer 11

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!)

Question 12

What does the Black Triangle after the name of the drug mean?

Answer 12

• 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)

Question 13

What is a rare ACR related to ACE inhibitors?

Answer 13

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

Question 14

What’s the purpose of reporting ADR via Yellow Card Scheme?

Answer 14

• to report ADRs that are not identified in clinical trials
• to identify new ADRs ASAP

Question 15

What is a serious reaction?

Answer 15

Serious reaction = reaction that is:

• life-threatening
• disabling/incapacitating
• results in a prolonged hospital stay
• results congenital abnormality
• medically significant

Question 16

Just have a look at that flashcard (examples of serious ADR)

Answer 16

Question 17

What are the modes that we can use the Yellow Card by?

Answer 17

• app
• online
• paper

Question 18

What information is needed (4) to report on Yellow Scheme Card?

Answer 18

• patient details (anomynasised: initials used, but weight, height, gender and age indicated)
• suspect drug
• suspect reaction
• reporter details

Question 19

Examples of reaction to ‘Spice’

Answer 19

‘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%)

Question 20

What is (1) serious ADR of Onivyde?

Answer 20

Onivyde - it is irinotecan, liposome injection

*used to treat colon cancer or small cell lung cancer

Serious/ fatal thromboembolic events