Pharmacovigilance Methods | Classification of Pharmacovigilance Methods | Pharmacovigilance notes

Pharmacovigilance Methods | Classification of Pharmacovigilance Methods | Pharmacovigilance notes

Pharmacovigilance Methods


  • To establish a functional reporting system to monitor the safety of all medicines
  • To learn more about the safety profile of new medicines in the early post-marketing phase
  • To learn more about the ADR profile of a specific medicine(s) in your population
  • To estimate the incidence of a known ADR to a specific medicine in your population
  • To gather more information on the safety profile of a new chemical entity in early post-marketing phase
  • To make use of existing electronic health records and registries to support pharmacovigilance activities

Classification of Pharmacovigilance Methods
1. Passive surveillance: • encompasses all spontaneous AEFI reporting from immunization service providers / hospitals /patients  up to next levels: state/territory then national (TGA) and then global

a. Spontaneous Reporting

b. Case Series

c. Targeted Reporting

2. Active surveillance:
• primarily used for characterization of the AEFI profile, rates and risk factors
• logistical and resource constraints limit wide application
• only for selected AEFI at selected institutions (sentinel) sites
• can also be carried out in the community setting (e.g. cohort event monitoring)

a. Sentinel Sites

b. Drug Event monitoring- can be divided into

i) Cohort Event Monitoring

ii) Medicine Event Monitoring

c. Registries

3.Ad hoc studies (Comparative observational studies):
• epidemiological studies (e.g. cohort study, case-control study, case series studies)
• focus on selected vaccine safety concerns (e.g. testing causality hypotheses)
• retrospective or prospective

4.Targeted Clinical Investigations

• PK and PD studies
• Genetic testing
• Interaction studies (drug-drug, drug-food)
• In special populations
• “Large simplified trial”

5. Descriptive Studies

• Natural History of Disease
• Drug Utilization Study

Which method and when it used?

Routine pharmacovigilance – (spontaneous reporting) is recommended for all products

• Enhanced/focused pharmacovigilance is better carried out under specified conditions when safety issues or potential safety issues need to be addressed
• Active studies are undertaken when data is needed quickly
• They often provide denominator values and thus useful for estimating burden/frequencies of events
• Some studies may be demanded by national authorities as part of the conditions for registration




Article Creator

Dr. Vivek Jain

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