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PHARMACOVIGILANCE

Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug reactions and other drug-related problems. It aims to improve patient safety and public health related to medicine use. Medical errors are among the leading causes of death in the US, with up to 100,000 deaths per year potentially resulting from errors. Post-marketing surveillance is important because clinical trials are limited in duration, number of patients, and conditions of use. Physicians, pharmacists, and pharmaceutical companies should report all suspected adverse reactions and problems to support pharmacovigilance efforts.

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625 views15 pages

PHARMACOVIGILANCE

Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug reactions and other drug-related problems. It aims to improve patient safety and public health related to medicine use. Medical errors are among the leading causes of death in the US, with up to 100,000 deaths per year potentially resulting from errors. Post-marketing surveillance is important because clinical trials are limited in duration, number of patients, and conditions of use. Physicians, pharmacists, and pharmaceutical companies should report all suspected adverse reactions and problems to support pharmacovigilance efforts.

Uploaded by

manveer84
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Pharmacovigilance

:- manveer kashinwar
?

 Number of deaths resulting from


medical errors in the US may be 100
000 per year.

 Medical errors are among leading


causes of death – more prevalent then
motor vehicle accidents. 5 % of all
deaths may be caused by
pharmaceuticals.
What is
Pharmacovigilance ?
 Pharmacovigilance is the science
and activities relating the detection
, assessment, understanding, and
preventaion of adverse effects or
any other possible drug releating
problems.
Terms

 Adverse Event (AE) – any untoward


medical occurrence that may present
during treatment with a pharmaceutical
product but which does not necessarily
have a casual relationship with this
treatment
 Adverse Drug Reaction (ADR) – a
response to a drug which is noxious and
unintended, and which occurs at doses
normally used in man.
Importance of
pharmacovigilance in
every country

?
Aim of Pharmacovigilance
 Improve patient care and safety as
well as
 Improve public health and safety
in relation to the use of medicines.
 Contribute to the assessment of
benefit , harm effectiveness and
risk of medicines.
New Drug Approval Process
Sources of Information on Drug
Safety
 Pre-clinical studies
 Clinical trials (pre- and post-
marketing)
 Spontaneous adverse reaction
reporting
 Periodic Safety Update Report
(PSUR)
Pre-clinical Studies
Standard toxicology pre-clinical tests are:
 Acute toxicity

 Repeat use toxicity

 Local irritation tests

 Pyrogenity

 Reproductive toxicity

 Carcinogenity
Clinical Trials

 Principal aim of clinical is to collect


safety ( and efficacy) data.
 The sponsor shall keep detailed records
of all adverse events and he shall submit
these records on request of regulatory
authority.
 The sponsor shall ensure that all
relevant information about suspected
serious unexpected adverse reactions
have to be recorded and reported to
regulatory authority
 Other investigators participating in
Reasons for Post-Marketing
Surveillance

 Tests in animals are insufficiency


predictive of human safety
 In clinical trials patients are selected
and limited in number
 Conditions of use in trials differ from
those in clinical practice
 Duration of trials is limited
Who Should Report Safety
Data
 Physicians

 Pharmacists

 Pharmaceutical companies
qualified persons –
(Pharmacovigilence/Regulatory
manager)
What to Report – WHO
recommendations
 Every single problem related to the
use of a drug, because probably
nobody else is collecting such
information
 All suspected adverse reactions
 ADRs associated with vaccines,
diagnostics, drugs used in traditional
medicine, herbal remedies, cosmetics,
medical devices and equipment
 Lack of efficacy and suspected
pharmaceutical defects
A Vigilant today for

Safe

Tommorrow
THANK YOU

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