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Pharmacology > Adverse drug reactions > Flashcards

Adverse drug reactions Flashcards

ABCDE classification of ADRs; Factors that contribute to ADRs; High risk pt groups; Severity classification of ADRs; Incidence classification of ADRs; Identifying ADRs; Common ADRs; Clinical trials; Reporting ADRs; Effect of interactions; Mechanism of drug interactions; Food and drink interactions

1
Q

Definition of an ADR

?dose, given for what?

A

Toxic, unintended response of body to drug when given at a normal dose for treatment/prophylaxis

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2
Q

4 features of ADRs

always … and …, detrimental to … cause complications to …

A

Always harmful
Always impact pts recovery/wellbeing
Detrimental to patients trust in prescriber and drug
Cause complications to care/finances

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3
Q

ADRs can be useful true or false?

A

True

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4
Q

Is an overdose an ADR?

A

No

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5
Q

Definition of an adverse drug event

A

Group term for the errors made when prescribing or dispensing a drug

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6
Q

What are the 3 types of ADR classification?

A

ABCDE
Severity
Incidence

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7
Q

What does the ABCDE of ADR classification stand for?

A 
Augmented 
Bizzare 
Chronic 
Delayed 
End of dose
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8
Q

Definition of a augmented ADR?

A

Excessive reaction to a drug

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9
Q

What are 3 features of an augmented ADR?

Frequency, ?morbidity ?mortality, related to …, can they be predicted?

A

Common- high morbidity, low mortality
Dose related
Predictable yes

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10
Q

Definition of a bizzare ADR?

A

unpredictable reaction to a drug

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11
Q

What are 3 features of a bizzare ADR?

severity, are they dose related, effect which group why

A

Serious
Not related to dose
Likely to effect minority groups as they are not included in clinical trials

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12
Q

Definition of chronic ADR

A

Induced over a long time, body adapting to drug

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13
Q

Definition of a delayed ADR

A

Develops after a period of time having had the drug

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14
Q

Definition of end of dose ADR

A

Withdrawl reaction when drug is stopped

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15
Q

Where can the incidence of ADRs for a drug be found?

A

Under summary of produce characteristics

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16
Q

What unit are incidence ADRs given in and what for patients are they better being given as?

A

%

Better given as frequency

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17
Q

5 classifications of incidence ADRs

A 
Very common 
Common 
Uncommon 
Rare 
Very rare
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18
Q

What is the % and frequency (fraction) of a very common ADR?

A

> 10%

>1/10

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19
Q

What is the range of % and frequency (fractions) of a common ADR?

A

1-10%

1/100 - 1/10

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20
Q

What is the range of % and frequency (fractions) of a uncommon ADR?

A

01-1%

1/1000 - 1/100

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21
Q

What is the range of % and frequency (fractions) of a rare ADR?

A

0.01-0.1%

1/10000 - 1/1000

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22
Q

What is the % and frequency (fraction) of a very rare ADR?

A

<0.01

1/10000

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23
Q

4 categories of ADR severity

A

Mild
Moderate
Severe
Life threatening

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24
Q

Definition of a mild ADR

A

May not be noticed by pt

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25
Q

Definition of a moderate ADR

A

Requires correcting but doesnt require admission to hospital

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26
Q

Definition of a severe ADR

A

Damage to patients organs, requires hospital admission

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27
Q

7 factors that contribute to pts risk of ADR

A 
Age 
Sex 
Ethnicity 
Comorbidities 
Allergies 
Polypharmacy 
Narrow therapeutic index
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28
Q

7 high risk pt groups for ADRs

A 
Elderly
Children 
Female 
Heart arrythmia 
HIV 
Abnormal metabolism 
Allergies
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29
Q

6 reasons why elderly are at increased risk of ADR

A 
Organ deterioration 
Low homeostatic reserve, less ability to compensate 
Cardiac/CNS drugs effect at lower dose 
New drug may cause AKI 
Multiple comorbidities 
Polypharmacy
30
Q

4 reasons why children are at increased risk of ADRs

A

Different metabolism/excretion of drugs to adults
Different pharmodynamics
Children excluded from clinical trials
Water and fat distribution changes quickly altering drug distribution

31
Q

2 reasons why ADRs more common in females than males

A

?better reporting

Difference in hormonal/immune systems

32
Q

What area of the body is more likely to have a reaction to drugs in HIV patients?

A

Skin

33
Q

If patient experiences suspected ADR should another drug be added, or ?

A

Drug causing ADR should be changed

34
Q

Acronym for identifying ADRs, what does each letter stand for and mean?

A

TRIP
Time - of ADR after drug administered
Recovery - ADR stop after not taking drug
Independent - test to objectively monitor ADR e.g. BP
Predictable - ADR understandable from drug’s method of action

35
Q

5 common drug interactions and their resulting ADRs

A 
NSAIDs + corticosteroids = dyspepsia 
Laxatives + abx + cytoxics = diarrhoea 
ACE inhibitors = dry cough 
Opioids + tricyclic antidepressants + iron = constipation 
Opioids + cytotoxics + SSRIs = Nausea
36
Q

5 common food/drink interactions with drug/their effect

A 
Grapefruit juice - enzyme inhibitor 
Cranberry juice + warfarin 
Milk/dairy products = chelation 
Alcohol + antidepressants = additive 
St Johns Wort + oral contraceptives = enzyme inducer
37
Q

What does chelation mean?

A

Formation of insoluble compounds by agents converting metal ions into inert versions of drug

38
Q

6 ways to reduce ADRs

A

Take pt history - predisposing factors, high risk group
Current/past drug history
Medication reviews
Regular monitoring of known ADRs - drugs with narrow therapeutic index
Pt aware of what to do when ADR occurs
Prescription of lower risk drug

39
Q

Definition of pharmacovigillance

A

Monitoring of a drugs effect after on population being introduced to see its effect

40
Q

Definition of a drug interaction

presence of what on what, changes what

A

Occur when effect of a drug or food changes with presence of another drug, chemical or food

41
Q

How can you identify a drug interaction in the BNF?

A

Will have a black dot next to it

Or be in bold text with a pink background

42
Q

3 outcomes of drug interaction

work any more?, effect

A

Ineffective
Increase in effect
Beneficial harmful effect

43
Q

Definition of a drug with a narrow therapeutic window

A

Difference between therapeutic and toxic dose of drug is very small

44
Q

What should be done when a patient is on a drug with a narrow therapeutic window and to ensure what?

A

Monitor plasma concentration of drug to ensure concentration remains within therapeutic range

45
Q

Name 2 types of drug interaction effect

A

Additive

Antagonistic

46
Q

Define a additive interaction effect

A

Drug interaction increases or adds to drugs effect

47
Q

Define a antagonistic drug interaction effect

A

Drug counteracts the action of the other, meaning desired therapeutic effect doesnt occur

48
Q

Name 2 mechanisms of drug interaction

A

Pharmodynamically

Pharmokinetically

49
Q

What feature of a drug to the one being given may result in a pharmodynamic interaction?

A

Drug with similar antagonist effect

50
Q

What 3 things might cause one drug interact to effect the absorption of another drug?

A

Dose of drug
Alteration of GIT motility/pH
Chelation

51
Q

How might a drug interact with another to effect its distribution?
(displace where, why cause ADR)

A

Displacement of protein bound drug- leaving unbound drug bioactive causing ADR/toxicity
Lower albumin concentration - same reason as above

52
Q

How in general terms might a drug interact with another to effect metabolism?

A

Increase or decrease the rate of drug break down

53
Q

What would a drug do to increase the metabolism of another?

A

Induce enzymes

54
Q

What is the effect of a drug enzyme inducer on drug concentration?

A

Decrease plasma concentration of drug

55
Q

What would a drug do to decrease the metabolism of another?

A

Inhibit enzymes

56
Q

What is the effect of a drug enzyme inhibitor on drug concentration?

A

Increase in plasma concentration of drug

57
Q

Would drug dose need to be increased or decreased when taken with a enzyme inducer to have same therapeutic effect?

A

Increased

58
Q

Would drug dose need to be increased or decreased when taken with an enzyme inhibitor to have same therapeutic effect?

A

Decreased

59
Q

How might one drug interact to effect the excretion of another when they are both excreted renally? Ad what effect on drug plasma conc would this have?

A

Compete to be removed

Increase drug plasma concentration

60
Q

Clinical trials only identify common ADRs true or false?

A

True

61
Q

What is the usual sample size involved in a clinical trial?

A

1500

62
Q

What 2 incidences of ADRs wont have occurred in a clinical trial?

A

Uncommon and rare

63
Q

Is the duration of a clinical trial short or long?

A

Short

64
Q

True or false, clinical trials involve minority populations?

A

False

65
Q

What system and organisation is in place to report ADRs?

A

Yellow card scheme to MHRA

66
Q

In well established drugs which ADRs should be reported?

A

Serious, medically significant ADRs with harmful reactions

67
Q

What should be reported as an ADR?

which drugs, just drugs?, smoking

A

Ineffective drugs
Medical devices
Conterfeit drugs
Nicotine devices

68
Q

What group term should all ADRs be reported for?

A

Minority groups e.g. elderly, children etc

69
Q

What symbol shows that a drug is new and under increased monitoring?

A

Upside down black triangle

70
Q

Where can you find out if a drug is new and under increased monitoring?
(2 places_

A

On summary of medical product characteristics

On patient information leaflet

71
Q

In a new drug identified with a upside down triangle should all ADRs be reported, Yes or no?

A

Yes

Pharmacology (10 decks)

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