Pharmacovigilance Methods | Classification of Pharmacovigilance Methods | Pharmacovigilance notes
Pharmacovigilance Methods
Objective:
- 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
Reference
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4953463/
https://pubmed.ncbi.nlm.nih.gov/18523760/
Article Creator
Dr. Vivek Jain