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Adverse drug reaction Pharmacist > ADR > Flashcards

ADR Flashcards

1
Q

What is ADR?

A

A response to a medicinal product which is noxious and unintended

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2
Q

How are ADR’s classified?

A
  • Rawlins and Thompson

- DoTS

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3
Q

Describe Type A of Rawlins and Thompson ADR?

A
  • Dose related
  • Common, predictable
  • Related to the pharmacology
  • Low mortility
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4
Q

Give examples of drugs that cause type A Rawlins and Thompson ADR?

A

Digoxin toxicity
Constipation from morphine
Sedation from a hypnotic

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5
Q

Describe Type B of Rawlins and Thompson ADR?

A
  • Not dose related
  • Uncommon, unpredictable
  • Not related to pharmacology
  • High mortality
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6
Q

Give examples of drugs that cause type B Rawlins and Thompson ADR?

A
  • Penicillin hypersensitivity
  • Malignant hyperthermia
  • Hepatitis
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7
Q

Can ACE-inhibitor induce angioedema. TRUE OR FALSE?

A

TRUE

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8
Q

ACE-inhibitor induced angioedema is is life threatning, rare and unlikely to to be picked up in clinical trials. TRUE OR FALSE?

A

TRUE

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9
Q

What are the 4 other types of Rawlins and thompson ADR classifications?

A

-Type C,D,E AND F

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10
Q

Describe type C,D,E and F of Rawlins and thompson ADR classification?

A

Type C - Long term
Type D - Delayed
Type E - End of use (withdrawal)
Type F -Failure of treatment

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11
Q

What does DoTS stand for?

A
  • D - Dose
  • T - Time
  • S - susceptibility
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12
Q

Dose (response), When can ADR occur? and provide an example for each occurance.

A
  • At doses below therapeutic doses e.g anaphylaxis with penicillin
  • In the therapeutic dose range e.g Nausea with morphine
  • At high doses e.g Liver failure with paracetamol
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13
Q

Time (course) can be characteristic; with the first dose, early or after a time or with long term treatment or delayed. TRUE OR FALSE?

A

TRUE

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14
Q

Time is relevant to pharmacovigilance and drug development. TRUE OR FALSE?

A

TRUE

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15
Q

Time can be independent or immediate. TRUE OR FALSE?

A

TRUE

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16
Q

provide an example for time-independent?

A

eg Increased risk of haemorrhage with change in effective dose of warfarin, should monitor closely throughout

17
Q

provide an example for time-immediate?

A

This is due to rapid administration e.g red man syndrome from vancomycin, therefore infuse slowly

18
Q

What are the increased risks due to with susceptibility?

A
  • Genetic variation
  • Age
  • Sex
  • Physiological variation
  • Exogenous factors
  • Disease
19
Q

With susceptibility, more than one fcator can be present. TRUE OR FALSE?

A

TRUE

20
Q

Provide examples of each:

  • Genetic variation
  • Age
  • Sex
  • Exogenous factors
  • Disease
A
  • Genetic variation - Malignant hyperthermia
  • Age - Elderly - hypnotics
  • Sex - Mefloquine (used to treat malaria)
  • Exogenous factors - Drug intercations/intercations with food
  • Disease - Renal insufficiency e.g lithium
21
Q

Provide an example of DoTS with regards to Osteoporosis due to corticosteriods?

A
  • Osteoporosis due to corticosteriods
    Dose - Collateral effect
    Time - Late
    Susceptibility - older people / women
22
Q

Provide an example of DoTS with regards to Anaphylaxis due to penicillin?

A

Dose - hypersusceptibility
Time - First dose of a course
Susceptibility - Not understood; needs previous sensitisation

23
Q

Provide an example of DoTS with regards to Hepatoxicity due to isoniazid?

A

Dose - Collateral effect
Time - Intermediate
Susceptibility - Genetics (drug metabolism), age, exogenous (alcohol), disease (malnutrition)

24
Q

Why are ADRs reported?

A

-Important for patient safety
-Allow continous monitoring of old and new drugs
-Provide data on ADRs to new drugs
-Provide data in special patients groups
(young and old, pregnant and with co-morbidities or polypharmacy)

25
Q

What does the yellow card scheme collect information on?

A

Collects reports of suspected problems or incidents involving;

  • ADRs
  • Medical device adverse incidents
  • Defective medicines (those that are not of an acceptable quality)
  • Counterfeit or fake medicines or medical devices
26
Q

What is a serious reaction?

A
  • includes prolonged hospitalisation
  • fatal
  • life-threatning
  • disabling/incapacitating
  • Cause congenital abnormalities
  • medically significant
27
Q

Medical significance can be mild, moderate, severe or lethal. TRUE OR FALSE?

A

TRUE

28
Q

Describe mild (medical significance)

A

-No antidote or treament is required

29
Q

Describe moderate (medical significance)

A
  • A change in treatment, but necessarily discontinuation of drug
  • Hospitalisation may be prolonged
  • Or specific treatment may be required
30
Q

Describe severe (medical significance)

A
  • An ADR is potentially life threatning and requires discontinuation of drug
  • Specific treament of ADR
31
Q

Describe lethal (medical significance)

A

-An ADR directly or indirectly contributes to patients death

32
Q

What is the meaning of a black triangle?

A

-Means intensive monitoring

33
Q

When are medications given a black triangle?

A
  • When contains new active substance
  • Is a biological medicine
  • New indications
  • Has conditional approval
  • Company been asked for more data
34
Q

What type of reports are the MHRA keen on?

A
  • Children
  • Over 65s
  • Biological medicines and vaccines
  • Delayed ADRs and interactions
  • Complimentary and herbal medicines

Adverse drug reaction Pharmacist (1 decks)

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