Introduction

DEFINITION:
 It is the pharmacological science relating to the

detection, assessment, understanding and prevention of
adverse effects particularly long term and short term side
effects of medicines or any other drug-related problem.
 The purpose is to identify new information about
hazards related to medicines and preventing harm to patients
Pharmacovigilance is an arm of patient care. It aims at
getting the best outcome of treatment with medicines. No one
wants to harm patients, but unfortunately, because of many
different factors, any medicine will sometimes do this.
Good pharmacovigilance will identify the risks in the
shortest possible time after the medicine has been marketed
and will help to establish/identify risk factors.
 concerned with the ADR (Adverse Drug Reaction)
“Any unfavorable and unintended sign, symptom
or a disease temporarily associated with the use

of medicinal product (drug).”
 Pharmacon=drug, vigilare=to keep awake, alert, or to

keep watch.
 branch of Pharmacoepidomology- the study of use

and effects of drugs in huge population.
 It uses the methods of epidemology and is

concerned with all aspects of benefit – risk ratio for
populations.
History
 After the Thalidomide Episode in 1960, efforts began in

the direction of drug safety Which led to the formation of
Pharmacovigilance.
WHO established its Programme for International Drug
Monitoring in response to the thalidomide disaster
detected in 1961.
 Together with the WHO Collaborating Centre for
International Drug Monitoring, Uppsala, WHO promotes
PV at the country level.
At the end of 2010, 134 countries were part of the WHO
PV Programme.
 The purpose is to detect unknown and poorly
understood adverse effects.
Need of Pharmacovigilance
There is a need to monitor

the effects of drugs during
the clinical trials and after
its launch in the market.
Because Adverse events

can happen during the
clinical trials and even
after its launch in market
Why Pharmacovigilance in Clinical Trials
 After completing Pre-
Clinical studies in animals,
first time trial drug will be
administered to the
Human.
 At this time the drug will

act in different way to the
Human body
 Chances of Adverse events

will also persist
Pharmacovigilance in Post Marketing – Why?
 At the time of approval, clinical trial data is

available on limited number of patients treated for
relatively short periods.
 Once a product is marketed, large number of

Patients may be exposed, including :
 Patients with Co-morbid illness
 Patients using concomitant medications
 Patients with chronic exposure

Aims
 Early detection of unknown adverse reaction and
interactions
 Detection of increased frequency of known

adverse reaction
 Identification of risk factors and possible

mechanisms underlying adverse reactions
 Estimation of quantitative aspects of benefits or

risk analysis.
Objectives
 Detection and study of adverse drug

reaction
 Measurement of risk
 Measurement of effectiveness
 Benefit and harm evaluation
 Dissemination of information like

a) Early warnings
b) Safe usage of drug
Goals
 Monitor the quality of drugs
 Identify the health risks involved in the

administration of drugs
 Prevent harm to patients
 Research the efficacy of drugs

Who reports about Adverse Events in Clinical trials
and in PMS
Investigator
Clinical Trials
Sponsor
PMS Clinical Trials
PMS
Consumers,
Physicians, Health care Health
Professionals Authority
Partners in Pharmacovigilance
• Government
• Pharmaceutical Industry
• Hospitals
• Medical and Pharmaceutical associations
• Health professionals
• Patients
• Consumers
• World Health Organization
• Media
How does Pharmacovigilance help the public?
Pharmacovigilance helps
save thousands of lives each
year, by monitoring the
adverse effects of drugs right
from the lab to the pharmacy
and then on for many years.
Pharmacovigilance keeps
track of any drastic effects of
drugs.
This way it prevents harm to

patients using those drugs.
How does Pharmacovigilance help Drug
Manufacturers?
Pharmaceutical Companies spend millions of dollars and a
considerably long-time in developing new drugs. They
again spend a lot of money in conducting clinical trials
before the drugs are approved and launched in the market.
But after all this, if there are adverse effects to the drugs,
the company again loses millions of dollars in sales and
litigations.
Furthermore, the reputation of the company is also

severely damaged. Pharmacovigilance monitors the
development of the drug across various stages and assesses
its effectiveness after its launch for many years. This way it
may reduce the adverse risk from drugs, thereby aiding
the drug manufacturers.
Rationale for pharmacovigilance
 Prevents Disasters
 Builds up customer confidence
 Ensures compliance and retention
 Builds brand image

What to report?
1.ADR associated with vaccines, diagnostics, drugs
used in traditional medicine, herbal remedies,
cosmetics, medical devices and equipment.
2.Lack of efficacy and suspected pharmaceutical

products
3. Overdose
4. Every single problem related to the use of a drug

Terms commonly used
1.Adverse drug reaction (ADR) is a side effect

occurring with a drug where a positive causal relationship
between the event and the drug is thought, or has been
proven, to exist.
2.Adverse event (AE) is a side effect occurring with a drug.

By definition, the causal relationship between the AE and the
drug is unknown.
3.Benefits: proven therapeutic good of a product but should

also include patient’s subjective assessment of its effect.
4. Causal relationship is said to exist when a drug is
thought to have caused or contributed to the occurrence
of an adverse drug reaction.
5. Dechallenge and Rechallenge refer to a drug being

stopped and restarted in a patient, respectively.
Dechallenge and rechallenge play an important role in
determining whether a causal relationship between an
event and a drug exists.
6. Effectiveness: it is used to express the extent to which a

drug works under real world circumstances i.e., clinical
practice (not in clinical trials)
7. Efficacy: it is used to express the extent to which a drug
works under ideal circumstances i.e., clinical trials.
8. Harm: it is the nature and extent of actual damage that

could be caused.
9. Individual Case Study Report (ICSR) is an adverse

event report for an individual patient.
10. Risk: it is the probability of harm being caused usually

expressed as a percent or ratio of the treated population.
11. Triage refers to the process of placing a potential adverse
event report into one of three categories: 1) non-serious case;
2) serious case; or 3) no case (minimum criteria for an AE
case are not fulfilled).
12. The Pharmacovigilance Centre is responsible for meeting the

requirements for good pharmacovigilance of all medicines
and is a centre of expertise for the art and science of
monitoring and analysis and the use of the analysed
information for the benefit of patients. National and any
regional Pharmacovigilance Centres should be set up with
the approval of the authority responsible for the regulation of
medicines (“regulatory authority”). The centre may function
within the regulatory authority, a hospital, an academic
institution or as an independent facility such as a trust or
foundation.
Passive or active Pharmacovigilance
Passive pharmacovigilance
Passive surveillance means that no active measures are taken to look

for adverse effects other than the encouragement of health
professionals and others to report safety concerns.
Reporting is entirely dependent on the initiative and motivation of

the potential reporters. This is the most common form of
pharmacovigilance.
It is commonly referred to as “spontaneous” or “voluntary”

reporting. In some countries this form of reporting is mandatory.
Passive or active Pharmacovigilance
Active Pharmacovigilance
Active (or proactive) safety surveillance means that active measures
are taken to detect adverse events.
This is managed by active follow-up after treatment and the events

may be detected by asking patients directly or screening patient records.
It is best done prospectively.
The most comprehensive method is cohort event monitoring (CEM)
Cohort Event Monitoring : Cohort Event Monitoring (CEM) is a prospective,

observational study of events that occur during the use of medicines, for
intensified follow-up of selected medicinal products phase. Patients are
monitored from the time they begin treatment, and for a defined period of time.

Introduction

Uploaded by

Copyright:

Available Formats

Introduction

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Introduction

Uploaded by

Copyright:

Available Formats

DEFINITION:

 It is the pharmacological science relating to the

or a disease temporarily associated with the use

 Pharmacon=drug, vigilare=to keep awake, alert, or to

 branch of Pharmacoepidomology- the study of use

 It uses the methods of epidemology and is

 After the Thalidomide Episode in 1960, efforts began in

There is a need to monitor

Because Adverse events

 At this time the drug will

 Chances of Adverse events

 At the time of approval, clinical trial data is

 Once a product is marketed, large number of

 Patients with Co-morbid illness

 Patients using concomitant medications

 Patients with chronic exposure

 Detection of increased frequency of known

 Identification of risk factors and possible

 Estimation of quantitative aspects of benefits or

 Detection and study of adverse drug

 Benefit and harm evaluation

 Dissemination of information like

 Monitor the quality of drugs

 Identify the health risks involved in the

 Prevent harm to patients

 Research the efficacy of drugs

• Medical and Pharmaceutical associations

• World Health Organization

This way it prevents harm to

Furthermore, the reputation of the company is also

 Builds up customer confidence

 Ensures compliance and retention

 Builds brand image

2.Lack of efficacy and suspected pharmaceutical

4. Every single problem related to the use of a drug

1.Adverse drug reaction (ADR) is a side effect

2.Adverse event (AE) is a side effect occurring with a drug.

3.Benefits: proven therapeutic good of a product but should

5. Dechallenge and Rechallenge refer to a drug being

6. Effectiveness: it is used to express the extent to which a

8. Harm: it is the nature and extent of actual damage that

9. Individual Case Study Report (ICSR) is an adverse

10. Risk: it is the probability of harm being caused usually

12. The Pharmacovigilance Centre is responsible for meeting the

Passive surveillance means that no active measures are taken to look

Reporting is entirely dependent on the initiative and motivation of

It is commonly referred to as “spontaneous” or “voluntary”

This is managed by active follow-up after treatment and the events

It is best done prospectively.

The most comprehensive method is cohort event monitoring (CEM)

Cohort Event Monitoring : Cohort Event Monitoring (CEM) is a prospective,

You might also like