7. Dr.
Ramesh
Bhandari
Clinical Trials
Approx. 4000-5000 individuals exposed
In 3 phases
Identify adverse reactions of a frequency
greater than 0.5 – 1.0%
“Children, elderly, multiple disease patients
and pregnant women are normally
excluded”
8. Dr.
Ramesh
Bhandari
Post Marketing Surveillance
Benefit for the identification of all drug
related risks
Include active and passive
pharmacovigilance methodologies
Spontaneous Reporting System
Pharmaco-epidemiological
methods
9. Dr.
Ramesh
Bhandari Spontaneous Reporting
System
Most sensitive, powerful and cost effective system
for identification of ADR
Every health care practitioner should report any
suspicion of a drug unexpectedly causing a risk to
patient situation.
Outcome – signals generation of unknown
problems.
“Not possible to quantify the risk”
10. Dr.
Ramesh
Bhandari
Pharmacoepidemiological Methods
Verify the hypothesis of a causal link between drug
exposure and an ADR.
Also possible to quantify the risk
Various pharmacoepidemiological methods
includes
Case reports
Cohort studies
Case-Control studies
13. Dr.
Ramesh
Bhandari
In Hospital Setup
Healthcare professionals can detect ADRs during ward
rounds with the medical team or during review of the patients
treatment chart.
To assist detection of ADRs, healthcare professionals should closely
monitor patients who are at high risk. These include:
◦ Patients with renal or hepatic impairment
◦ Patients taking drugs which have a potential to cause ADRs example:
Narrow therapeutic agents
◦ Patients who had previous allergic reactions
◦ Patients taking multiple drug therapy (poly pharmacy)
◦ Pregnant and breast feeding women.
14. Dr.
Ramesh
Bhandari
In Hospital Setup
First step in detection of ADR is data collection.
Data to be collected includes patient’s demographic information,
presenting complaints, past medical and medication history, drug
therapy details including OTC, current and medication on
admission, laboratory investigation details,
Details of suspected ADR such as time of onset of reaction,
nature and severity, details of the suspected drug including dose,
frequency, time of administration, duration of treatment, plasma
concentration of the drug,
Previous reports on reactions, data on any other causes including
risk factors and predisposing factors.