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ADR Flashcards

1
Q

Definition of adverse events

A

Medical occurrence temporally associated with use of a medicinal product
NOT necessarily causally related

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2
Q

Definition of side effects

A

Unintended effect occurring at normal doses, due to pharmacological properties of medicinal product
May be positive/negative

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3
Q

Definition of adverse drug reactions

A

Response to drug that is noxious/harmful & unintended
Causal relationship
Occurs at doses normally used in prophylaxis, treatment, diagnosis of disease / for modification of physiological function
Excludes medication errors, overdose, drug abuse

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4
Q

Definition of serious adverse reaction

A

Adverse effect that is unintended, occurs at normal doses & causes any of the following outcomes:

1) Death
2) Life-threatening
3) Hospitalization / Prolonged hospital stay
4) Persistent/Significant disability/incapacity
5) Congenital abnormalities / Birth defects
6) Judged to be medically important, even though effect might not be immediately life-threatening / result in death/hospitalization
- Jeopardize patient health OR
- Requires intervention to prevent any one of the outcomes mentioned above

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5
Q

Definition of labelled / Expected / Listed ADR

A

ADR that is adequately described, in terms of kind, intensity, specificity
Listed in package insert / summary of product characteristics

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6
Q

Definition of unexpected ADR

A

ADR not consistent with product information / characteristics of drug

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7
Q

Definition of spontaneous reporting

A

Voluntary submissions of reports on AEs/ADRs by HCPs to national regulatory authority, outside of systematically planned studies

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8
Q

Definition of mandatory reporting of ADRs

A

Legal obligation

Pharmaceutical companies mandated by law to report suspected ADRs

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9
Q

Definition of prevalence

A

No. of cases of an event in a given population within a given period of time
Includes old & new cases

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10
Q

Definition of incidence

A

No. of NEW cases of an event in a given population within a given period of time

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11
Q

Definition of frequency

A

Prevalence OR Incidence OR Both

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12
Q

What is the frequency of:

1) Very common
2) Common (frequent)
3) Uncommon (infrequent)
4) Rare
5) Very rare

A

1) ≥ 1/10
2) ≥ 1/100 & < 1/10
3) ≥ 1/1,000 & < 1/100
4) ≥ 1/10,000 & < 1/1,000
5) < 1/10,000

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13
Q

Definition of pharmacoepidemiology

A

Study of utilizations & effects of drug in large no. of people

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14
Q

Types of studies used in pharmacoepidemiology

A

1) Cohort studies
2) Case studies
3) Nested case studies
4) Case-cohort studies
5) Cross sectional studies

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15
Q

Definition of predictive values

1) Positive predictive values
2) Negative predictive values

A

1) Probability that, if patient tests positive, patient actually has disease
2) Probability that, if patient tests negative, patient truly does not have disease

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16
Q

Definition of pharmacogenetics

A

Study of how different individuals respond differently to therapy/treatment due to differences in genes/genetic makeup

17
Q

Detecting ADRs - Rule of three

A

If a given ADR is not detected in a clinical trial with population size of ___, can say with 95% confidence that frequency of that ADR is < 3/population size

18
Q

Limitations of clinical trials in terms of detecting ADRs

A

1) Small sample size
- ~ 1,500-3,000 patients exposed to drug prior to approval
- Clinical trials generally only able to detect common ADRs (frequency = 1/100 - 1/1,000)

2) Short duration
- Unable to detect ADRs that occur after long-term treatment

Overall: 50% of approved drugs have serious adverse effects not detected prior to approval

19
Q

ICH E1 guidelines

A

Purpose: Establish guidelines for extent of population exposure needed to assess clinical safety of drugs intended for long-term treatment (chronic / repeated intermittent use for > 6 months) in non-life-threatening conditions

Guidelines:

1) Expose 300-600 patients to drug for 6 months
- Most ADRs will occur within first few months of treatment
2) Expose 100 patients to drug for min 1 year
- Concerns over ADRs that may occur after treatment lasting > 6 months
- 100 patients sufficient –> reasonable assurance that true accumulative 1 year incidence ≤ 3%

20
Q

Causes of ADR

A

1) Inherent drug characteristics
2) Quality issues
- Toxic heavy metal contaminants
- Counterfeits/Substandard products
3) Long term use/High doses
4) Adulterants
5) Substitution of ingredients
6) Individual susceptibility
- Genetic variation
7) In-use problems
8) Drug interactions
- Drug-drug / Drug-food

21
Q

Toxic heavy metal limits

A

Arsenic - 5 ppm
Cadmium - 0.3 ppm
Lead - 10 ppm
Mercury - 0.5 ppm

22
Q

Adverse events commonly associated with drug use

A

1) SJS
2) TEN
3) Agranulocytosis
4) Acute dystonia
5) Drug-induced liver injury (DILI)
6) Cushing’s syndrome

23
Q

SJS / TEN

1) Non-drug induced causes
2) Mortality rate
3) Incidence
4) Clinical presentation

A

1) Viral / Bacterial / fungal

2) SJS: 5%
TEN: 40%

3) 1-6/million/year

4) Widespread erythematous macules
Severe mucosal erosion (at eyes, oropharynx, genitalia, anus)
Epidermal detachment
- SJS: < 10%
- TEN: > 30%
- Transitional SJS-TEN: 10-30%
24
Q

Drug-induced liver toxicity (DILI)

1) Non-drug induced causes of acute liver failure
2) Mortality rate
3) Incidence
4) Diagnosis

A

1) Viral infection
2) Up to 12%
3) 7-13/100,00 (European studies)
4) CIOMS-RUCAM Scale

25
Q

CIOMS-RUCAM

A

Determine score, based on scoring parameters

Score is used to determine likelihood of DILI, based on scoring system

26
Q

CIOMS-RUCAM Scale - Scoring system

A 
≤ 0: Relationship with drug excluded
1-2: Unlikely
3-5: Possible
6-8: Probable
> 8: Highly probable
27
Q

Cushing syndrome

1) Causes
2) S/Sx

A

Causes:

1) Adrenal tumour
2) Cushing disease - pituitary tumour causing overproduction of ACTH
3) Ectopic ACTH-producing tumour
4) Exogenous sources
- Knowingly (e.g. prescribed corticosteroids) or unknowingly (e.g. adulterated with steroids)

S/Sx:

1) Increased appetite, weight gain
2) Insomnia
3) Cushing appearance: Moon face, buffalo hump, truncal weight gain
3) Increased BP
4) Increased BG
5) Weakened immunity
6) Bone loss
7) Cataracts

28
Q

Causality assessment - Factors to consider

A

1) Pharmacological plausability
2) Chronology
3) Synergistic (Pharmacokinetic / Broad sense)
4) Alternative

29
Q

Causality assessment - Factors to consider

A

1) Pharmacological plausibility
2) Chronology
3) Synergistic (Pharmacokinetic / Broad sense)
4) Alternative

30
Q

Causality assessment - Pharmacological plausibility

A

Consider:

1) Chemical nature of drug
2) Assumable intrinsic activity
3) PK fitting
4) Duration & dosage
5) Phenomenological plausibility due to previous cases (prinicple of Bayes)

31
Q

Causality assessment - Chronology

A

Consider:

1) Temporal relationship
2) Dechallenge, possibly rechallenge

32
Q

Causality assessment - Synergistic

A

1) Pharmacokinetic
- Other drug/factor that does NOT cause AE on its own BUT increases concentration of drug in consideration, enabling drug in consideration to cause Type A reaction

2) Broad sense
- Other drug/factor that can cause the AE on its own and could also in combination cause the whole quantitative degree of the effect

33
Q

Causality assessment - Alternative

A

Other drug/factors which alone & specifically can cause AE –> exonerate drug under consideration

34
Q

Causality classes

A 
Certain
Probable
Possible 
Unlikely
Unclassified/Unassessable
35
Q

Causality classes - criteria

A

Certain

  • Pharmacologically clear & plausible
  • Chronologically well-fitting challenge/de-challenge, possibly re-challenge
  • Time relationship: Within 30 ming
  • Lab data specifically implicating drug

Probable

  • Pharmacologically clear
  • Close temporal / spatial correlation
  • Recovery upon withdrawal
  • Clinically uncommon phenomenon / reasonable exclusion of other causes

Possible

  • Pharmacologically not excludable
  • Chronologically well-fitting challenge/de-challenge
  • Time relationship unclear
  • More than one drug
  • Explainable by other causes
  • Information on AE unclear/incomplete

Unlikely

  • Chronological sequence hardly fitting
  • Plausible explanation by other causes
36
Q

Causality assessment - Methods

A

1) WHO-UMC causality assessment
2) Naranjo causality assessment
3) CIOMS-RUCAM (for DILI)

Errors (6 decks)

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