Yellow card scheme Flashcards
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.
What’s the difference between adverse reactions vs. side effects?
ADR - unpleasant
Side effects - may be beneficial as well as harmful
Why are ADRs a problem?
- Major clinical problem - increase morbidity and mortality
- Financial burden on NHS £466m
- ADRs are 4th leading causing of deaths in U.S.
- 0.15% patients suffer fatal ADRs - 5700 deaths per year
- 6.7% of hospitalised patients suffer ‘serious’ ADRs
- 6.5% of adults and 2.1% of hospital admissions are ADRs
- 40% of community patients experience ADRs
ADRs can result in …
- Affect patient compliance
- Reduce available choice of drug treatment
- Reduce potential efficacy of a drug treatment
- Reduce quality of life
- Cause diagnostic confusion
- Reduce a patients potential in their healthcare professional
What is a Class A ADR?
Common ADRs - aprox. 80% of ADRs
Predictable, dose related, usually not severe
Example: Constipation with opioids
What is a Class B ADRs?
Unpredictable, not dose related, may be very sever/fatal
With new drugs, ADRs are not well recognised
Example: Stephens-Johnson syndrome following ibuprofen therapy
What is a Class C ADR?
Chronic treatment effects
Example: Osteoporosis with steroids
What is a Class D ADR?
Delayed effects
Example: Drug induced cancers
What is a Class E ADR?
End of treatment effects
Example: Withdrawal symptoms with opiates
What is Class F ADR?
Failure of therapy
Example : Unexpected failure of therapy due to drug interaction i.e. combined oral contraception and rifampicin
What is Class G ADR?
Genetic or genomic
Example: Irreversible genetic damage i.e. carcinogens, teratogens.
What are the 3 factors in ADRs
- Dose - at which the ADR can occur:
– Below the therapeutic dose - i.e. anaphylaxis with penicillin
– In therapeutic dose - i.e. nausea with morphine
– Above therapeutic dose - i.e. liver failure with paracetamol - Time - of onset can be characteristic:
– With the first or second dose - i.e. anaphylaxis with penicillin
– Early, or after a time, or with long term treatment - i.e. first few days: nitrate induced headaches
10 days - 10 weeks: peptic ulcers with NSAIDs
Several weeks: drug induced Cushing’s syndrome
– On stopping treatment (withdrawal) i.e. opiate withdrawal syndrome
– Delayed i.e. Drug induced cancers - Susceptibility - of patients can be defined:
– 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
What are the high risk groups when it comes to ADRs and why?
Younger children:
- Dose needs tailoring to age/weight
- Not able to identify potential error
Older adults:
- Co-morbidities
- Polypharmacy
- Diminished reserves
- Reduced renal or hepatic function
What are the top 10 drugs/drug groups associated with ADRs?
- NSAIDs
- Diuretics
- Beta-blockers
- Anti-depressants
- Warfarin
- Prednisolone
- Opioids
- Digoxin
- ACE inhibitors
- Clopidogrel
What symptoms may indicate an ADR?
– Abnormal clinical measurements whilst on drug therapy i.e. BP, Blood temp, blood glucose, weight etc.
– Abnormal laboratory results whilst on drug therapy i.e. biochemical or haematological
–New therapy started which could be used to treat ADR
– Reducing the dose or stopping the drug alleviates the symptoms (if the symptoms reoccur after reintroducing the drug then drug is most likely responsible)
How can ADRs be avoided?
– Avoid unnecessary drug use
– Avoid /reduce drug interactions (check patients drug history before prescribing)
– Consider risk factors for ADRs i.e. age, reduced hepatic and renal function
– Avoid new (black triangle ) drug
– Patient counselling
– Monitor patient and optimise dose
– Consider prophylactic therapy where appropriate (prevention than cure i.e. vaccines etc)
What is pharmacovigilance?
Monitoring the effects of drugs after they have been licensed for use, in order to identify and evaluate previously unreported ADRs
Why is it important to report ADRs?
– Only a handful of ADRs are known at licensing, so important to understand the full side effects after licensing.
– Important role in patient safety
– To detect rare adverse side effects
– Allows for continual safety monitoring of drugs
– For new drugs: lack of experience on adverse effects and special patient groups i.e. elderly, children, pregnancy etc.
What is the yellow card scheme?
– A system to report any side effects reported of any drugs that are licenced and on the market
– Acts as an early warning system to identify ADRs and risk factors
What are black triangle drugs?
The black triangle is used to indicate that a medicine is being intensively monitored and is assigned to:
– new drugs
– new combination drugs
– novel routes or delivery systems for drugs
– significant new indications for drugs
– With black triangle medicines ALL suspected ADRs should be reported, even if not serious
What should be reported under the yellow card scheme?
All serious suspected ADRs for both adult and children:
– Fatal
– Life threatening
– Disabling or incapacitating
– Result in or prolong hospitalisation
– Congenital abnormalities
– Medically significant
What category of ADRs are the MHRA particularly interested in?
– In children
– Patients over 65
– Biological medicines
– Vaccines
– Delayed drug effects/interactions
– Complimentary therapies i.e. herbal medicines
– Defective counterfeit or fake medicines
How can someone report through the yellow card scheme?
Either by filling in a paper copy and returning to the freepost address (these can be found in the BNF and yellow card information leaflets) OR ONLINE at www.mhra.gov.uk/yellow card OR on yellow card app
What clinical systems are used in the reporting of side effects/yellow cards?
Mi Databank
Cerner
Systemone
Vision
What is meant by ‘looking for signals’?
“A signal is reported information on a
possible causal relationship between an
adverse event and a drug, the
relationship being unknown or
incompletely documented previously.
Usually more than a single report is
required to generate a signal, depending
on the seriousness of the event and the
quality of the information.” WHO 1991
Why is signal detection important?
Important for improving patient safety:
STEPS:
1. Signal detection
2. Signal detection meeting
3. Data gathering
4. Signal evaluation
5. Action
What actions can be done after identifying a signal?
– 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 done but can be withdrawn from the market
How would you alert people of the changes made?
– Central Alerting System
– Drug Safety Update (monthly)
– Dear Healthcare Professional letters (ad hoc)
– Updated product information (PIL and SPC)
– BNF safety warnings (CSM warnings)
– Targeted information for patients and working
with stakeholders
– Social Media
– MHRA website
– Press releases/ campaigns
