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PMP103 > Yellow card scheme > Flashcards

Yellow card scheme Flashcards

1
Q

What is an adverse drug reaction?

A

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.

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2
Q

What’s the difference between adverse reactions vs. side effects?

A

ADR - unpleasant
Side effects - may be beneficial as well as harmful

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3
Q

Why are ADRs a problem?

A
  1. Major clinical problem - increase morbidity and mortality
  2. Financial burden on NHS £466m
  3. ADRs are 4th leading causing of deaths in U.S.
  4. 0.15% patients suffer fatal ADRs - 5700 deaths per year
  5. 6.7% of hospitalised patients suffer ‘serious’ ADRs
  6. 6.5% of adults and 2.1% of hospital admissions are ADRs
  7. 40% of community patients experience ADRs
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4
Q

ADRs can result in …

A
  1. Affect patient compliance
  2. Reduce available choice of drug treatment
  3. Reduce potential efficacy of a drug treatment
  4. Reduce quality of life
  5. Cause diagnostic confusion
  6. Reduce a patients potential in their healthcare professional
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5
Q

What is a Class A ADR?

A

Common ADRs - aprox. 80% of ADRs
Predictable, dose related, usually not severe
Example: Constipation with opioids

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6
Q

What is a Class B ADRs?

A

Unpredictable, not dose related, may be very sever/fatal
With new drugs, ADRs are not well recognised
Example: Stephens-Johnson syndrome following ibuprofen therapy

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7
Q

What is a Class C ADR?

A

Chronic treatment effects
Example: Osteoporosis with steroids

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8
Q

What is a Class D ADR?

A

Delayed effects
Example: Drug induced cancers

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9
Q

What is a Class E ADR?

A

End of treatment effects
Example: Withdrawal symptoms with opiates

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10
Q

What is Class F ADR?

A

Failure of therapy
Example : Unexpected failure of therapy due to drug interaction i.e. combined oral contraception and rifampicin

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11
Q

What is Class G ADR?

A

Genetic or genomic
Example: Irreversible genetic damage i.e. carcinogens, teratogens.

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12
Q

What are the 3 factors in ADRs

A
  1. 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
  2. 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
  3. 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
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13
Q

What are the high risk groups when it comes to ADRs and why?

A

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

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14
Q

What are the top 10 drugs/drug groups associated with ADRs?

A
  1. NSAIDs
  2. Diuretics
  3. Beta-blockers
  4. Anti-depressants
  5. Warfarin
  6. Prednisolone
  7. Opioids
  8. Digoxin
  9. ACE inhibitors
  10. Clopidogrel
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15
Q

What symptoms may indicate an ADR?

A

– 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)

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16
Q

How can ADRs be avoided?

A

– 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)

17
Q

What is pharmacovigilance?

A

Monitoring the effects of drugs after they have been licensed for use, in order to identify and evaluate previously unreported ADRs

18
Q

Why is it important to report ADRs?

A

– 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.

19
Q

What is the yellow card scheme?

A

– 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

20
Q

What are black triangle drugs?

A

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

21
Q

What should be reported under the yellow card scheme?

A

All serious suspected ADRs for both adult and children:
– Fatal
– Life threatening
– Disabling or incapacitating
– Result in or prolong hospitalisation
– Congenital abnormalities
– Medically significant

22
Q

What category of ADRs are the MHRA particularly interested in?

A

– In children
– Patients over 65
– Biological medicines
– Vaccines
– Delayed drug effects/interactions
– Complimentary therapies i.e. herbal medicines
– Defective counterfeit or fake medicines

23
Q

How can someone report through the yellow card scheme?

A

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

24
Q

What clinical systems are used in the reporting of side effects/yellow cards?

A

Mi Databank
Cerner
Systemone
Vision

25
Q

What is meant by ‘looking for signals’?

A

“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

26
Q

Why is signal detection important?

A

Important for improving patient safety:
STEPS:
1. Signal detection
2. Signal detection meeting
3. Data gathering
4. Signal evaluation
5. Action

27
Q

What actions can be done after identifying a signal?

A

– 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

28
Q

How would you alert people of the changes made?

A

– 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

PMP103 (13 decks)

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