WEEK 11 - The Yellow Card Scheme

Question 1

What is ADRs

ADRs = Adverse Drug Reactions

Answer 1

An unwanted or harmful reaction which occurs after drug has been administered

Response is:
- To the specific drug given
- Unintended / not planned
- Reaction occurs at dose normally used for prophylaxis, diagnosis or treatment
- i.e. not toxic

Question 2

How do we identify ADRs

Answer 2

6 Classifications: Type A to F
- Most reactions seen are Type A and B

The 6 ADRs
1. Type A (augmented)
- reactions seen are predictable
- dose dependant reactions
- if stop or ↓ dose = reaction reversed
- 80% of all ADRs

2. Tybe B (bizzare)
   - unpredicatble reactions
   - more rare
   - i.e. can’t predict from drugs known pharmacology
   - e.g. anaphylactic reaction
3. Type C (chronic)
   - dose dependnent
   - time dependent = effects may not show immediately
   - require ongoing monitoring
4. Type D (delayed)
   - reaction doesn’t occur immediately but sometime after drug use
   - difficult to link reaction to specific med = harder to manage
5. Type E (end of use)
   - occurs after stopping drug use
   - e.g. withdrawal symptoms
   - managed by gradual dose reduction
6. Type F (failure of therapy)
   - drug given at its known therpeutic dose but no therpeutic effect occured
   - detrmine cause e.g. DDI, patient compliance

Question 3

How do we prevent ADRs

Answer 3

• Medicines reconciliation
  - ensures we have an accurate list of meds + continutity of care
• Rationalised prescribing
  - every med prescribed has a purpose
  - evidence based RX-ing
  - optimised
• Medication review
  - regualr reviews to identify + act on problems quickly
• Deprescribing
  - in older pts with polypharmacy + co-morbirities
• Patient monitoring and follow up
  - counsel pts to correctly monitor at home
  - HCPs do clicnical follow ups
• Education and training for all HCPs
  -

Question 4

How do we manage ADRs

Answer 4

• Is immediate response required?
  - what type of ADR is seen
  - mild or more severe / life-threatening
  - need to manage acute severe ADRs quickly to ↓ harm
• Adjust medication regimen
  - adjust doses
  - e.g. deprescribing, med reveiws
• Supportive care
  - ensure pt well being is prioritised
  - e.g. monitoring, treating
• Guidelines and Protocols
  - If pt hosipitilasted follow local guidelines
• Treat presenting symptoms
  - e.g. if ADR caused electrolyte imbalance = need to treat
• Patient education
  - inform pt about potnetial ADRs / SE of their meds for future

Question 5

What clinical guidance is available for ADRs

Answer 5

• BNF
• NICE - Treatment summaries
  
  • has section explaining how it is managed
• CKS

Question 6

What is the role of The Yellow Card Scheme

Answer 6

MHRA system to monitor medication + medical device safety

• Collects data abour ADRs, safety concerns, problems linked to medical devices
  
  • e.g. device not working correctly, clinical issuses
• Allows for ongoing monitoring of drugs
  - can recognise patterns
  - add to areas where data is lacking e.g. special pt groups like pregnancy, children (less clincial trials conducted in these areas)
  - used as early warning systems
  - info. can inform policies and guidelines

Question 7

Why should you report ADRs via The Yellow Card Scheme

Answer 7

• Implictaions it may have on pt outcomes
• NHS cost implications (70% of ADRs are avoidable)
• To prevent + reduce occurence of ADR admissions
• Reduce deaths caused by ADRs
• Professional responsibility
• Increasing population age = polypharmacy + comorbidity = ISSUE
• Increase use of OTC, herbal meds, online meds, supplements = ↑ safety issue

Question 8

Who should report ADRs and How

via The Yellow Card Scheme

Answer 8

WHO:
ALL HCPs
* Doctors & medical students
* Dentists
* Nurses, midwives, health visitors, HCAs
* Patient and carers
* Pharmacists & pre-reg students
* Optometrists, chiropodists, radiographers, paramedics
* Coroners

HOW:
- Online via MHRA
- Telephone
- Yellow car app
- BNF
- Midatabank software

Question 9

What should ADRs be reported

via The Yellow Card Scheme

Answer 9

WHAT:
- Suspected serious reactions
- i.e. death, diabled, life-threatening, disabling, hospitilisation
- All black triangle drugs
- All New Medicine Service (NMS) associated medicines
- ADRs not mentioned in PIL/SmPC (novel)
- ALL paediatric and geriatric (elderly) ADRs
- children less likely to be in clincal trials = little known info
- elderly = more sensitive to ADRs
- Biologics and vaccines
- Herbal and complementary therapies
- Medical devices

Question 10

What are the outcomes of reporting via The Yellow Card Scheme

Answer 10

• Increased knowledge about drug + effects in SPG
• Restricted use of mediciation
  - indication and duration updated
  - special warning added
  - age range changed
• Drug safety updates
• Recall of products (taken off market)
• Reduced risks of SE
  - safer use of drug
• Use resources like iDAPs
  - shows info. reported about specific drug via MHRA ]
  - gives overview on info collected around SE / ADRs

Question 11

What is causality

Answer 11

Is the relationship between cause + effect
- i.e. is there is a chance this specifc medication caused this ADR

• Considers how things influence one another
  
  • e.g. symptoms presented + current medication

Use TRIP
T -Timing
- when did it happen/start?
- interval between when drug was taken and ADR reported
- drug PD, may influence timeline

R - Recovery
- have symptoms improve, gone or partially there
- if suspected drug has been stopped = de-challenge (to resolve)

I - Independent evidence
- are there other potential causes of ADR beside drug
- e.g. underlying illness
- if think ADR was not related to drug = re-challenge (restart drug again)

P - Predictable
- based off known drug pharmacology
- are symptoms. consistent with whats known about drug

Question 12

How does causality inform reporting

Answer 12

• Always think does a yellow card need to be completed
  
  • if not WHY