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Pharmacology > ADRs > Flashcards

ADRs Flashcards

1
Q

What is an adverse drug reaction?

A

unwanted or harmful reaction following administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug

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2
Q

give examples of mild ADRs

A

nausea
rash
drowsiness

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3
Q

give examples of serious ADRs

A

respiratory depression
neutropenia
catastrophic haemorrhage
anaphylaxis

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4
Q

Why are ADRs important?

A 
5th commonest cause of hospital death
majority are preventable
affects pt's quality of life
pts lose confidence in their doctors 
increases cost of pt care
prevent drugs being used in pts
may mimic disease 
cause hospital admissions
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5
Q

What is the Rawlins Thompson classification?

A 
Augmented
Bizarre/idiosyncratic
Chronic
Delayed
End of treatment
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6
Q

What are the causes of ADRs?

A 
pharmaceutical variation
receptor abnormality 
abnormal biological system unmasked by a drug
abnormalities in drug metabolism
immunological
drug to drug interactions 
multifactorial
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7
Q

Explain what an augmented drug reaction is

A

predictable
dose dependent
common
extension of primary effect or a secondary effect of the drug

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8
Q

Give examples of an augmented drug reaction

A

bradycardia and propanolol
hypoglycaemia and insulin
haemorrhage and anticoagulants
secondary effect - bronchospasm with beta blockers

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9
Q

Explain what a bizarre reaction is

A 
not predictable
not dose dependent 
cannot be readily reversed
less common but often serious
can be either idiosyncrasy or allergy/anaphylaxis
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10
Q

Give examples of bizarre reactions

A

penicillin and anaphylaxis

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11
Q

What is idiosyncrasy?

A

inherent abnormal response to a drug

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12
Q

Give examples of types of iodiosyncrasy

A

enzyme deficiency

receptor abnormality

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13
Q

Give an example of an enzyme deficiency that causes an idiosyncratic reaction

A

haemolysis with primaquine

due to G6PD deficiency (glucose 6 phosphate dehydrogenase)

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14
Q

Give an example of a receptor abnormality that causes an idiosyncratic reaction

A

malignant hyperpyrexia with GA

this is a drastic and sustained rise in body temperature

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15
Q

Explain how allergy to a drug develops

A

first dose acts as an antigen
then Ab is produced
second dose is an Ag-Ab reaction

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16
Q

What are the types of hypersensitivity reaction?

A

type 1 - immediate anaphylactic IgE mediated
type 2 - Cytotoxic, antibody-dependent IgM or IgG (Complement) MAC
type 3 - Immune complex disease
type 4 - delayed hypersensitivity T cell mediated

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17
Q

Give examples of a chronic type ADR

A

steroids and osteoporosis
analgesic nephropathy
steroids an iatrogenic Cushings syndrome
colonic dysfunction due to laxatives

18
Q

Give examples of delayed ADRs

A

teratogensis - eg drugs taken in the first trimester - thalidomide
carcinogenesis - cyclophosphamide (chemo and immunosupressant) can cause bladder cancer

19
Q

Give an example of end treatment ADRs

A

abrupt withdrawal of glucocorticoids leads to adrenocortical insufficiency
withdrawal seizures when anti-convulsants are stopped

20
Q

What are the pt risk factors for ADRs?

A 
gender (W>M)
elderly
neonates
polypharmacy
genetic predisposition
hypersensitivity/allergies
hepatic/ renal impairment
adherence problems
21
Q

What are the drug risk factors for ADRs?

A

steep-dose response curve

low therapeutic index

22
Q

Give examples of prescriber risks for ADRs

A 
prescription errors
erroneous medical decisions
ommissions in the prescription
poor handwriting
inadequate knowledge
inadequate communication between HCWs
23
Q

What are the suggestions that an ADR is occurring?

A

symptoms soon after a new drug is started
symptoms after a dosage increase
symptoms disappear when the drug is stopped
symptoms reappear when the drug is restated

24
Q

What are the most common drugs to have ADRs?

A 
antibiotics eg penicillin
anti-neoplastics
cardiovascular drugs 
hypoglycaemics eg insulin
NSAIDs
CNS drugs
25
Q

What are the most common systems to be affected by an ADR?

A 
GI
Renal
Haemorrhagic
metabolic 
endocrine
dermatological
26
Q

What are common drug reactions?

A 
confusion
diarrhoea
nausea
constipation
balance problems
hypotension
27
Q

How can ADRs be avoided?

A

give appropriate meds
don’t give unnecessary meds
check for interactions
report ADRs

28
Q

What does the Medicines and Healthcare products regulatory agency do?

A
  1. approves medicines and devices for use
  2. watches over the medicines and devices and takes actions eg drug withdrawal to protect the public if there is a problem
29
Q

What is the yellow card scheme?

A

ADR reporting scheme
collects spontaneous reports
collects suspected drug reactions
voluntary reporting

30
Q

What are the strengths of the yellow card scheme?

A

Acts as an early warning system for identification of previously unrecognised ADRs
provides info about which factors predispose to ADRs
allows comparison of ADR profiles between products in the same therapeutic class, so could use another drug instead if found to be safer
continual safety monitoring
cheap to operate
rapid
readily accessible
can be applied widely and throughout a drugs use

31
Q

What are the weaknesses of yellow card reporting?

A

cannot provide estimate of risk as number of cases is underestimated and total number of pts exposed is unknown
ADR may not be recognised
ADRs may not be reported
reporting increases when there is a new drug and decreases over time

32
Q

Why are ADR reporting rates low?

A
  • people not sure how to report
  • people don’t want to be foolish as to incorrectly identifying an ADR
  • people do not want to expose themselves to legal liability/ don’t want to admit harm caused
  • people too busy to report ADR
  • people believe that only safe drugs are used
33
Q

What does the code of practice say about recording ADRs?

A
  1. Drs MUST report (inform MHRA) all suspected ADRs to medicines and products with a black triangle in the BNFusing the yellow card scheme
  2. MUST inform MHRA about adverse incidents involving medical devices, incl. those caused by human error that put or have the potential to put the safety of pts and HCWs at risk
  3. should provide pts with information about how they can report suspected side effects to the MHRA
34
Q

Why should we report ADRs?

A

important for pt safety
to identify ADRs not identified in clinical trials
to identify new ADRs
to compare drugs in the same therapeutic class
to identify ADRs in at risk groups

35
Q

What reactions should be reported on a yellow card?

A

all suspected reactions for herbal medicines AND black triangle drugs
all serious suspected reactions for established drugs and vaccines

36
Q

What does the black triangle mean?

A

a medicine that is undergoing additional monitoring

37
Q

Give reasons as to why a drug may be undergoing additional monitoring

A

contains a new active substance
is a biological medicine eg a vaccine or a medicine derived from plasma
has been given conditional approval or only approved under certain circumstances
the company is collecting data on the drug

38
Q

What is a serious reaction?

A 
fatal
life-threatening 
disabling or incapacitating 
results in hospitalisation
prolongs hospitalisation
39
Q

Who can report on a yellow card?

A 
doctors 
dentists 
coroners
pharmacists 
nurses 
midwives
health visitors 
radiographers 
optometrists 
pts and carers and parents
40
Q

What info should be included in a yellow card?

A 
suspected drugs 
suspected reactions 
pt details 
reporter details 
additional useful info

Pharmacology (10 decks)

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