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HDT 2.1 > Adverse drug reactions > Flashcards

Adverse drug reactions Flashcards

1
Q

Which class of drugs has the highest percentage of known side effects?

A

NSAIDs have highest known side effects

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2
Q

What is an adverse dug reaction?

A

any response to a drug that is noxious and unintended and that occurs at doses used in man for prophylaxis, diagnosis or therapy

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3
Q

What the EU definition of ADR?

A
  • response to a medicinal product which is noxious and unintended
  • ADR from occupational exposure
  • ADR from the use outside the terms of the marketing authorisation. including overdose, off-label use, misuse, abuse and med errors
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4
Q

What is an adverse drug event?

A

an adverse outcome in a patient which occurs after the use of a drug, but which may or may not be linked to use of the drug

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5
Q

What is the definition of a serious reaction?

A

reaction which results in or prolongs hospitalisation

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6
Q

What did Rawlins Thompson propose in 1977 for reactions?

A

He proposed 2 types of reaction- A and B

Type A was dose related and relating to pharmacology and Type B as non-dose related

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7
Q

What were Thompson’s Type A drugs factors?

A
  • dose related
  • common, predictable
  • low mortality
  • related to the pharmacology
  • bigger the dose, the bigger effect it’ll have
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8
Q

What were Thompson’s Type B drugs factors?

A
  • not dose related
  • uncommon
  • high mortality
  • bizarre reactions
  • not related to pharmacology
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9
Q

Explain what is ACE-inhibitor induced angioedema?

A
  • life threatening
  • rare
  • unlikely to be picked up in clinical trials
  • swelling of lips, tongue, airways, lynphx
  • can be a side effect of ACE inhibitor long term
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10
Q

Explain what is Type C reaction introduced by Grahame-Smith

A
  • dose related and time related
  • uncommon
  • related to cumulative dose
  • repeated and chronic use of a drug leads to an ADR
  • don’t use high dose steiroids- can cause this
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11
Q

Explain what is Type D reaction introduced by Grahame-Smith

A
  • time related
  • uncommon
  • usually dose related
  • occurs soon or some time after the use of the drug
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12
Q

What is an type E ADR?

A
  • withdrawal reactions
  • uncommon
  • occur soon after withdrawal
  • e.g. myocardial infarction after beta-blocker withdrawal and there’s no regulation of receptors
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13
Q

What is an type F ADR?

A
  • common
  • dose related
  • cause by DDI
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14
Q

Explain what the system DoTS

A 
3 factors- Dose, Time, Susceptibility 
Dose (response) The ADR can occur 
- at doses below therapeutic doses 
- in the therapeutic dose range 
- at high doses
Time ( Course) can be characteristic
- with the first dose
- early or after a time, or with long-term treatment
- on stopping treatment 
- delayed 
Susceptibility can be defined
- Genetics
- Age 
- Sex
- Physiological state 
- Disease 
- Exogenous drugs or food
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15
Q

What are the three reactions effects of Dose from DoTS?

A
  1. toxic
  2. collateral
  3. hypersusceptibility
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16
Q

What does the Dose-response curve look like?

A

It is therapeutic response on y axis and dose on x axis
an upwards curve that starts with hypersusceptibility and then steadily increases; this is collateral effects. When it plateaus finally this is due to toxic effects

17
Q

Using dots, how would you treat osteoporosis?

A

is due to corticosteroids
- traditional approach a Type C reaction

DoTS
Dose- collateral effect
Timing- late
Susceptibility- age, sex

18
Q

Using dots, how would you treat anaphylaxis?

A

is due to penicillin
-traditional approach a type B reaction

DoTS
Dose- hypersusceptibility
Timing- first dose
Susceptibility- unclear, but requires previous sensitisation

19
Q

what are the aims of casuality assessment?

A
  • to decide nature of further enquiries
  • to satisfy regulatory requirements
  • to decide whether a drug caused an ADR
  • to aid signal identification
  • to classify reports
  • to provide a basis for a label change
20
Q

Name some factors to consider in casualty assessment?

A
  • temporal relationship
  • clinical characteristics of event
  • existing info
  • patient characteristics
  • potential for DDI
  • concomitant med
  • underlying or concurrent diseases
21
Q

Describe what a temporal relationship is

A
  • timing can substantially strengthen a causal association as in the case of anaphylaxis
  • or the timing of the ADR may be misleading e.g. cholestatic jaundice
22
Q

What are some clinical events that can occur?

A
  • acute dystonia, blood dyscrasias and skin reactions are usually med-related
23
Q

What should be looked at in regards to existing info?

A
  • is the ADR in the literature?
  • has it been noted by others?
  • is it in BNF or SPC?
24
Q

What should be considered when looking at concomitant medication?

A 
What are other med being taken?
What are their adverse effects?
Have you taken a full med history?
(all drugs being taken)
( some drugs can have same effects)
25
Q

explain what dechallenge and rechallenge is

A
  • recovery after medicine withdrawal is important for a casual relationship
  • deliberate rechallenge is not ethical
  • recurrence on rechallenge is strongly suggestive that med was responsible and so not ethical

(patient consent and validation is needed)

26
Q

What questions must be asked in terms of patient characteristics for an ADR?

A
  • previous allergies?
  • hepatic or renal impairment?
  • history of atopy?
  • low body weight, sex, renal and hepatic function?
27
Q

When should you use Yellow cards?

A
  • for a spontaneous report
  • causation doesn’t need to be proved you only need suspicion
  • causal relationship is implied unless the reporter explicitly states a casual relationship has been excluded
28
Q

What does the consist of the Bradford Hill Criteria?

A
  1. Strength- is association strong?
  2. Consistency - does association occur in repeated studies in diff populations? suggests a casual link
  3. Specificity- how specific is the effect? true associations are more specific
  4. Temporality - cause must precede effect in time; consistent patterns suggest causality
  5. Biological gradient - is the effect dose-related? dose response suggests causation
  6. Plausibility - is there a mechanism for the effect? biological plausibility is important
  7. Coherence- is effect coherent with biological facts? shouldn’t conflict with known history facts
  8. Experimental - is there experimental evidence demonstrating the effect?
  9. Analogy- can an analogy be made with another association?
29
Q

What are the three methods of causality assessment?

A
  1. unrestricted clinical evaluation/global introspection
  2. algorithms, with/out scoring
  3. bayesian probabilistic methods
30
Q

What are the three methods that use subjective measures?

A
  1. global introspection
  2. striking case method
  3. unstructured clinical judgement
31
Q

What elements do rule- based methods contain and what is it?

A
  • involve rating an adverse event using a questionnaire or an algorithm
  • also known as generalised rule-based methods or standardised decision aids
    three elements:
    1. set of structured responses
    2. a weighting algorithm
    3. a scaling algorithm
32
Q

What are the benefits and limitations of algorithms?

A
  • reduce intra and inter-rater variability
  • variability may arise in less than perfect conditions
  • subjective questions lead to variations in scores
  • diff systems highly divergent
  • little attention given to design and validation
33
Q

What are the ranges for ADR possibility using the Naranjo scale?

A 
9= definite
5-8= probable 
1-4= possible
0= doubtful

most people score 1-4 or 5-8

34
Q

When should you assess causality?

A
  • clinical trials- investigator
  • spontaneous reports
  • on initial receipt of report
  • signal identification and evaluation
  • periodic review; aggregate data
35
Q

what is deterioration in kidney function usually associated with?

A

fulminant hepatitis

HDT 2.1 (11 decks)

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