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Patient PCP > Yellow card ADRs > Flashcards

Yellow card ADRs Flashcards

1
Q

What does ADR stand for ?

A

Adverse drug reaction

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2
Q

What is the definition of an ADR?

A

Response to a drug which is noxious (harmful) and unintended

  • within or outside the terms of the marketing authorisation
  • or from occupational exposure (e.g. overdose)
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3
Q

Toxicity definition?

A

Exaggeration of desired therapeutic effect

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4
Q

Side effect definition?

A

Any unintended pharmacological effect of medication

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5
Q

When might ADRs occur?

A

Adverse reactions may arise from use of the product. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.

The reaction may be a known side effect of the drug or it may be new and previously unrecognised.

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6
Q

What is an adverse drug event?

A

NOT the same as an ADR

  • Any undesirable event whilst taking a medication e.g. hit by a car whilst on a specific medication
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7
Q

What 4 drug groups account for 50% of ADR admissions in the UK?

A
  • Antiplatelets (including Aspiri)
  • Diuretics
  • NSAID’s
  • Anticoagulants
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8
Q

Example of an ADR mimicking disease state?

A

Patient is prescribed Fentanyl patch 12mcg/hour every 72 hours
BNF (palliative care section) : Fentanyl patch 12mcg = 30mg oral morphine daily
Using increasing oramorph as breakthrough (10mg /day)
>50% increase in dose
Patient becomes drowsy, hallucinations, falls
?opioid overdose or cerebral metatasis

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9
Q

What is a type A ADR reaction?

A
  • AUGMENTED reaction
  • usually dose related
  • Exaggeration of drug’s normal pharmacological action
  • low mortality
  • high morbidity
  • Greater susceptibility in renal or hepatic disease, young and old
  • 80% of all ADR’s
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10
Q

Examples of type A reactions?

A
  • Beta blocker causing bradycardia and hypotension
  • respiratory depression with opioids
  • bleeding with warfarin
  • also include those that are not directly related to the desired pharmacological action of the drug (e.g. dry mouth that is associated with tricyclic antidepressants).
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11
Q

What is a type B reaction?

A
  • BIZARRE
  • unpredictable response
  • not dose related
  • low morbidity
  • high mortality
  • lower incidence
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12
Q

Example of a type B reaction?

A
  • Allergic reactions
    - Anaphylaxis with penicillin
    - Skin rashes with antibiotics
  • Idiosyncratic reactions
  • Genetically determined effects
    - G6PD deficiency
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13
Q

What drugs have definite risk of haemolysis in most GP6D-deficient individuals?

A 
Dapsone, 
Nitrofurantoin, 
Primaquine, 
quinalones, 
co-trimoxazole
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14
Q

What is anaphylaxis?

A

Anaphylaxis is a severe, life-threatening, generalised or systemic hypersensitivity reaction. It is characterised by rapidly developing, life-threatening problems involving: the airway (pharyngeal or laryngeal oedema) and/or breathing (bronchospasm with tachypnoea) and/or circulation (hypotension and/or tachycardia). In most cases, there are associated skin and mucosal changes

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15
Q

What is Stevens Johnson Syndrome?

A

Stevens-Johnson syndrome is a rare condition arising from ‘over-reaction’ of the immune system to a trigger such as a mild infection or a medicine, leading to blistering and peeling of the skin and surfaces of the eyes, mouth and throat

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16
Q

What drugs cause Stevens Johnson Syndrome?

A
  • antibacterial sulfa drugs (sulfadiazine, sulfamethoxazole/trimethoprim)
  • anti-epileptic drugs (phenytoin, carbamazepine, lamotrigine, phenobarbital)
  • allopurinol
  • NSAIDs
  • antibiotics (penicillins)
17
Q

What is toxic epidermal necrosis (TEN)?

A

Another form of severe rash from drug reaction

  • Presents in variety of patterns
  • Typically: fever, flu like symptom before skin eruption
  • Crops on hands and feet more often than trunk.
  • May be blisters, papular or erythmatous
18
Q

What is a type C ADR?

A
  • Chronic

- Long term effects eg. Osteoporosis with steroids, analgesic nephropathy

19
Q

What is a type D ADR?

A
  • delayed

- teratogenesis/carcinogenesis

20
Q

What is an example of a type D reaction?

A

leucopoenia, which can occur up to six weeks after a dose of lomustine

21
Q

What is a type E ADR?

A
  • End of dose

- Withdrawal effects after long-term treatment

22
Q

Example of type E ADR?

A
  • SSRI withdrawal

- insomnia, anxiety and perceptual disturbances following the withdrawal of benzodiazepines

23
Q

What is a type F ADR?

A
  • failure

- e.g. oral contraceptive pill and rifampicin interaction

24
Q

What does the yellow card collect information on?

A

ADRs to all medicines including:

  • Vaccines
  • Blood factors and immunoglogulins
  • Herbal medicines
  • Homeopathic remedies
  • Contrast media
  • Prescriptions and OTC
  • Unlicensed medications
  • Medical devices adverse incidents
  • Defective medicines (unacceptable quality)
  • Counterfeit medicines and devices
25
Q

What should be reported to the yellow card scheme (MHRA)?

A
  • Report all SERIOUS reactions
  • Fatal, life-threatening
  • Result in or prolong hospitalisation
  • Disabling, incapacitating or medically significant
26
Q

What is the difference between a serious and a severe reaction?

A
  • A severe reaction may not be life threatening or disabling but can affect a patient
    E.g. headache can be severe but not usually serious
27
Q

What is indicated by an inverted black triangle ?

A
  • a new medicine

- report all suspected reactions

28
Q

What are areas of special interest that should be reported to the MHRA?

A
  • Delayed drug effects (eg cancers)
  • Congenital abnormalities
  • Children and Elderly
  • Herbal remedies
  • Biologicals and vaccines
  • Medication errors where harm occurs
29
Q

What are the risks factors for ADRs?

A
  • Multiple drug therapy (50% chance of an ADR if > 5 drugs)
  • Age (Young & Old)
  • Gender (Female > Male)
  • Race
    - Glucose 6 Phosphate Dehydrogenase
    (African/Asian prevalence)
    - Porphyria (South African prevalence)
  • Concomitant disease (Renal/Liver, HIV)
  • Genetics
  • Allergies
  • Pharmaceutical factors
30
Q

Specific drugs that are risk factors for ADR?

A
  • Anticoagulants and Antiplatelets
  • NSAIDs
  • Diuretics
  • Hypoglycaemic agents
  • Antibiotics
  • Drugs with a narrow therapeutic index
31
Q

How to tell if its an ADR?

A

TRIP

T - timing, has the patient taken the drug before? does the time course fit?

R - recovery, does the reaction disappear when drug is stopped?

I - independent evidence, Is there an alternative cause of the reaction?

P - predictable, Is the reaction typical for that drug?

Patient PCP (15 decks)

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