Yellow drug reactions & Yellow card scheme Flashcards
MHRA:
UK Government body responsible for medicines safety and licensing
YCC Wales
Funded by MHRA to promote understanding, reporting and research of side effects to medicines
What is an Adverse Drug Reaction?
An ADR is a response to a medicinal product which is noxious and unintended.
ADRs may arise from the 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.
Adverse Drug Reactions vs. Side Effects?
ADR - unpleasant or unwanted
Side effect - beneficial as well as harmful
ADRs can
reduce available choice of drug treatment
reduce quality of life
cause diagnostic confusion
reduce patient confidence in their healthcare professional
Classification of ADRs
Common ADRs – Approx. 80% of ADRs
Type A
Predictable, dose related
Bradycardia with beta blockers
Constipation with opioids
Usually not severe
Gastritis from NSAIDs
Uncommon but often well recognised ADRs
type B (‘Bizarre’)
Unpredictable, dose not rlated
very sevewre fatal
Classification of ADRs other
Type C (Chronic treatment effects)
[Osteoporosis with steroids]
Type D (Delayed effects)
[Drug induced cancers]
Type E (End of treatment effects)
[withdrawal syndromes with opiates]
Type F (Failure of therapy)
[Unexpected failure of therapy due to drug interaction
e.g. Combined Oral Contraceptive and rifampicin]
Type G (Genetic or Genomic)
[Irreversible genetic damage (carcinogens, teratogens)]
Important factors in ADRs: DoTS
3 factors: Dose, Time, Susceptibility
Dose at which the ADR can occur:
At doses below therapeutic doses
Anaphylaxis with penicillin
In the therapeutic dose range
Nausea with morphine
At high doses
Liver failure with paracetamol
Time of onset can be characteristic
- with 1st or 2nd dose
- early or after a time, with long-term treatment
- first few days
- 10 days - 10 weeks
- on stopping treatment
- delayed
- drug induced cancer
Susceptibility of patients can be defined
genetics
age
sex
physiological state
exogenous drugs or food
disease
Younger Children (high risk)
Dose needs tailoring to age/weight
Not able to identify potential error
older adults (high risk)
Co-morbidities
Polypharmacy
Diminished reserves
Reduced renal or hepatic function
Top 10 drugs/drug groups associated with ADRs
NSAIDS
beta blockers
Opioids
digoxin
prednisone
ACE inhibitors
diuretics
Clopidogrel
warfarin
What else may indicate an ADR?
Abnormal clinical measurements while on drug therapy
e.g. B.P, temp, pulse, blood glucose and weight
Abnormal laboratory results while on drug therapy
biochemical or haematological
New therapy started which could be used to treat ADR
Reducing the dose or stopping the suspected drug alleviates the symptoms
If drug reintroduced and symptoms recur, the drug is probably responsible
Listen to patients own concerns
Are ADRs avoidable?
Avoid unnecessary drug use
Avoid/reduce drug interactions
check the patient’s drug history before prescribing
Consider risk factors for ADRs e.g. age extremes, reduced hepatic and renal function
Avoid new (black triangle) drugs
Patient counselling
Monitor treatment & optimise dose
Consider prophylactic therapy where appropriate
Why report ADRs?
patient safety
detect rare adverse effects
safety monitoring of drugs (old and new)
NEW DRUGS - lack of experience wit adverse effects / short duration/ exposure in 3-4,000 people
The Yellow Card Scheme
Introduced in 1964 after the thalidomide tragedy
Receives spontaneous reports of suspected adverse drug reactions
Receives spontaneous reports of suspected adverse drug reactions
Over 1 million confidential reports received in UK
who can report to yellow card scheme?
anyone
What should I report?
report all suspected ADRs for new drugs marked - even if not seirous
what does black triangle indicate?
medicine is being intensively monitored
assigned to:
new drugs
new combinations of drugs
novel routes or delivery systems for drugs
significant new indications for drugs
What should i report?
fatal
life-threatening
disabling or incapacitating
result in or prolong hospitalisation
congenital abnormalities
medically significant
MHRA are paticurly interested in ssustpecteed ADRs
in children
> 65years
biological medicines
vaccines
delayed drug effects/ interactions
detective, counterfeit or fake medicines
By filling in a paper copy and returning to the FREEPOST address
Found in the BNF
Downloadable from www.mhra.gov.uk/yellowcard
Yellow Card information leaflets
Journey of yellow card shceme
Reports are scanned or automatically uploaded onto the MHRA’s database (sentinel) Up until recently each report was manually entered. Now due to the increased volume of reports due to COVID-19 vaccine programme Artifical Intelligence has been brought in to help.
Undergoes some Quality Assurance where they make sure essential fields are filled in, we have reporter details, drug name, reaction, patient identifier etc, there’s nothing weird with the report.
The reporter will receive and acknowledgement and/or a request for some more information (that request for more info can come at a later time)
All information is kept confidential. When a hcp reports the Patient name is not asked for. The patients initials and something like their local identifier number are included so that if more info is needed they know which patient it relates to. If a patient wants to report a side effect themselves but is not happy to give their name they could ask someone to report on their behalf.
Once everything looks good – that report is committed to the database and is then available to be analyzed.
That process takes about 48-72 hours. Which considering the volume of reports received daily by the MHRA is pretty incredible.
Once that data is there and available one of the first things that is done is to make it transparent so the info is included on the interactive drug analysis prints (iDAPS) – if works show quickly. And for enquiries.
Signal detection -> improved patient safety
1) signal detection
2) signal detection meeting
3) data gathering
4) Signal evaluation
5) action
Actions?
No action, investigate, expert advice, or wait for further evidence, continue to monitor
Change in legal status (P to POM)
Restrict pack size
Update patient leaflets and prescribing information to include new side effects
Restrict indications, reduce dose or introduce new warnings for use
Rarely - withdrawn from the market
