WHO defines pharmacovigilance as the science and activities
relating to the detection, assessment, understanding and
prevention of adverse effects of marketed medicines or those
The drug regulatory agencies have the responsibility of having a
well-established pharmacovigilance system to monitor adverse
reactions of drugs, during the drug development phase and later
during the life time of a marketed drug.
collects, records, codes ADEs / ADRs
analyses and assesses the reports
promotes the safe use of drugs
creates appropriate structures and means of
communication needed to perform its tasks
Aims of Pharmacovigilance
to improve patient care and safety
to improve public health and safety
to contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
to promote education and clinical training
to promote effective communication to the public
to promote rational and safe use of medicines
P-vigilance ---- A shared responsibility
Company – legally and morally responsible for
monitoring their product
Regulatory authorities – are responsible for the
safety of the drugs they license
Doctors – responsible to patients
Pharmacist & nurse – responsible to patients
P-vigilance ---- now a specialist discipline
Large drug companies have special
CROs establishing vigilance groups
Doctors – part of their practicing protocol
Pharmacovigilance - Data Sources
Spontaneous Reporting Systems
• National PV Centre / Drug Authority
• from the published scientific literature.
Adverse Reaction Case Reports by the MA(master
agreement) holder (e.g. collected by sales
Periodic Safety Update Report (PSUR) provided by
Drug event monitoring
Comparative observational studies
Cross-sectional study (survey)
Targeted Clinical Investigations
Natural history of disease
Drug utilization study
A communication by consumers or health care
professionals to a company or Regulatory Authority
that describes one or more ADR in a patient who was
given the drug.
Plays a major role in the identification of safety
signals once the drug is marketed
Gives alerts on rare AEs that were not detected in
earlier clinical trials or pre marketing studies.
Provides important information on at risk groups, risk
factors and clinical features of known serious ADRs.
Series of case reports can provide evidence of an
association of a drug and AE.
generally more useful for generating hypotheses than
for verifying an association between drug exposure
certain distinct adverse events occur more frequently
with drug therapy, such as anaphylaxis, aplastic
anemia, toxic epidermal necrolysis and Stevens-
Johnson Syndrome events such as these are
spontaneously reported for detailed and rapid follow-
A method used to encourage and facilitate reporting
by health professionals for new products, or for
limited time period.
Methods – On line reporting of AE, systematic
stimulation of reporting of AE.
Data are often incomplete.
Not useful to generate accurate incidence rates.
To ascertain completely the number of AE via a
continuous pre-organised process. Eg:Follow up of
patients treated with a particular drug.
More feasible to get comprehensive data on individual
Active surveillance carried out at Institutions,
Nursing homes, hospitals etc.
Provide information such as data from specific patient
subgroups, drug abuse etc.
Small number of patients
DRUG EVENT MONITORING
Patients are identified by electronic prescription
data or automated health insurance claims.
A follow up questionnaire can be sent to each
physician or patient at specified intervals.
Information on patient demographics, indication for
treatment, duration of therapy (including start dates),
dosage, clinical events, and reasons for discontinuation
can be included in the questionnaire.
Limitations: poor physician and patient
response rates and unfocused nature of data
collection can obscure important signals.
A modification of Drug Event Monitoring is
Cohort Event Monitoring (CEM), an active
pharmacovigilance method promoted by the
World Health Organisation and other
A registry is a list of patients presenting with same
characteristics.eg: Disease registry, drug registry or
Differ from each other depending on type of patient
Information can be obtained by using standard
Comparative Observational Studies
Traditional epidemiologic methods are a key
component in the evaluation of adverse events.
observational study designs are useful in validating
signals from spontaneous reports or case series.
types of designs
1. cross-sectional studies
2. case-control studies
3. cohort studies (both retrospective and prospective)
Cross-sectional study (survey)
Data collected from a population of patients at a
single point in time (or interval of time) regardless of
exposure or disease status.
primarily used to gather data for surveys or for
major drawback: relationship between exposure and
outcome cannot be directly addressed.
Adv:best used to examine the prevalence of a disease
at one time point or to examine trends over time,
when data for serial time points can be captured.
cases of disease (or events) are identified.
Controls, or patients without the disease or event of
interest, are then selected from the source population
The controls should be selected : the prevalence of
exposure among the controls represents the
prevalence of exposure in the source population.
exposure status of the two groups is then compared
using the odds ratio.
a population-at-risk for the disease (or event) is followed
over time for the occurrence of the disease (or event)
Information on exposure status is known throughout the
follow-up and hence incidence rates can be calculated.
comparison cohorts of interest are selected on the basis
of drug use and followed over time
Multiple adverse events can also be investigated using the
same data source in a cohort study
TARGETED CLINICAL INVESTIGATIONS
When significant risks are identified from pre-
approval clinical trials, further clinical studies might
be called for to evaluate the mechanism of action for
Pharmacodynamic and pharmacokinetic studies might
Specific studies to investigate potential drug-drug
interactions and food-drug interactions might be
primarily used to obtain the background rate of outcome events
and/or establish the prevalence of the use of drugs in specified
1. Natural history of disease: focused on the natural history of
disease, including the characteristics of diseased patients and
the distribution of disease in selected populations, as well as
estimating the incidence and prevalence of potential outcomes
1. Drug utilization study: These studies provide data on specific
populations, such as the elderly, children, or patients with
hepatic or renal dysfunction, often stratified by age, gender,
concomitant medication, and other characteristics.
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