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PVG

Definitions

Dr Bassi PU MBBS,MSc,FMCP

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Definitions

  • Pharmacovigilance
  • Adverse event
  • Adverse reaction
    • Serious adverse reaction
    • Unexpected adverse reaction
  • Side effect
  • Signal
  • Causality

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Definitions

Organisations involved

  • WHO - World Health Organization
  • CIOMS - Council of International Organizations

of Medical Sciences

  • ICH – International Conference on Harmonization

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Pharmacovigilance

WHO, 2002

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

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Adverse event/ experience

​

Untoward medical occurrence termporally associated

with the use of a medicinal product, but not

necessarily causally related

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Adverse reaction

WHO, 1972

​

’A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function’.

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Side effect

​

Unintended effect occurring at normal dose related

to the pharmacological properties of a drug

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Reporting outside the core definition

  • Medical error
  • Patient safety reporting
  • Drug ineffectiveness
    • individual therapeutic response
    • counterfeit medicnes
    • substandard medicines

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Unexpected adverse reaction

​

Not consistent with applicable product information

or characteristics of drug

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Signal

​

  • Possible causal relationship between adverse event and drug
  • Previously unknown or incompletely documented
  • More than one report is needed

Depending on:

    • Quality of the information
    • Seriousness of the event

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Serious adverse event or reaction

​

Any untoward medical occurrence that at any dose

    • results in death
    • is life-threatening
    • requires inpatient hospitalization or
    • prolongation of existing hospitalization
    • results in persistent or significant disability or incapacity
    • results in a congenital abnormality

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note on Serious adverse event or reaction

To ensure no confusion or misunderstanding of the difference between the terms 'serious' and 'severe', the following note of clarification is provided:

​

The term 'severe' is not synonymous with serious. In the English language, 'severe' is used to describe the intensity (severity) of a specific event (as in mild, moderate or severe);

the event itself, however, may be of relatively minor medical significance (such as severe headache).

Seriousness (not severity) which is based on patient/event outcome or action criteria serves as guide for defining regulatory reporting obligations.

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Frequency of adverse drug reactions (CIOMS)

Very common

>= 1/10

Common (frequent)

< 1/10 but >= 1/100

Uncommon (infrequent)

< 1/100 but >= 1/1000

Rare

< 1/1000 but >= 1/10 000

Very rare

< 1/10 000

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Causality gradings

​

  • Certain
  • Probable
  • Possible
  • Unlikely
  • Conditional / Unclassified
  • Unassessible / Unclassified

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Other key terms

​

  • Benefit - Harm
  • Effectiveness - Risk

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Benefit - Harm

Benefit

- the proven therapeutic good of a product, including patient’s subjective assessment of its effects

Harm

- the nature and extent of actual damage that may be caused It should not be confused with risk

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Effectiveness - Risk

Effectiveness

- the probability of the drug working as expected in the clinical setting (opposite of its risk)

Risk

- the probability of harm being caused during clinical use, usually expressed as a percentage or ratio; the probability (chance, odds) of a negative occurrence