POSTER PRESENTATION ON PHARMACOVIGILANCE.

1. PHARMACOVIGILANCE
AUTHOR:MOHAMMAD JUNED & SHAIKH AMAAN
MENTOR NAME : MR. SHAIKH SULEMAN A.R.
ABSTRACT:
Pharmacovigilance defined by the world health organization as "the science and activities relating to the detection, understanding,
assessment and prevention of adverse effects or any other drug related problems". It plays a key role in ensuring that patients
receive safe drugs. Our knowledge of a drug’s adverse reactions can be increased by various means, including spontaneous
reporting.
INTRODUCTION
Pharmacovigilance
Pharmakon-drug,
vigilare- to keep watch.
Aim of pharmacovigilance is to protect
public health by identifying, evaluating and
minimizing safety issues to ensure that the
overall benefits of medicines outweight
the risks.
CONTENT:
Pharmacovigilance
CONCLUSION
Pharmacovigilance is
a branch of
pharmacoepidemiol-
ogy but is restricted
to study on an
epidemiological scale
The process of
monitoring,
evaluating and
improving the
safety of medicines
in use.
Equal to drug monitoring
Pharmacovigilance system team collects:
•The valuable additional information, building up the scientific data contained in the
original report making it more informative.
Data is important for:
Treatment,to avoid drug side effect, to avoid illness.
Types of PV
1. Passive surveillance:
• No active measures are taken to look for adverse effects
• It is commonly referred to as “Spontaneous” or “Voluntary” reporting
2. Active or Safety surveillance:
• Active measures are taken to detect adverse event.
• This is managed by active follow-up after treatment and the event may be
detected by asking patients directly or screening patient records.
What is Adverse Drug Reaction (ADR) ?
As per World Health Organisation
(WHO), an ADR is a response to a
which is noxious and unintended and
which occurs at does normally in man
for Prophylaxis, diagnosis, or other
therapy of disease.
As per ICH, serious AdR is any
untoward medical occurrence that at
any dose:
1. Results in death
2. life-threatening
3. congenital anomaly/birth defect
Adverse events can be reported by:
1. Physician
2. Hospitals
3. Pharmacist
4. patient
5. patient relative.
Pharmacovigilance is the only way to ensure the safety of the drug throughout the life cycle. The knowledge and information
available regarding safety of any drug is very much important to take appropriate decision by drug regulators to safe guard public
health. Health care professionals are the main reporters of the ADRs. However there are high percentages of under-reporting
reported globally. It is the major challenge of today. In spite of those limitations, spontaneous reporting system remains as a most
widely used method to report ADRs and is able to generate signal of rare and very rare types of ADRs. If all the health care
professionals take ADR reporting as an ethical obligation and a major responsibility, we can make our world safer than what is today.
1. The importance of pharmacovigilance available at http://www.who_umc.org cited 18 December 2007.
2. Review Pharmacovigilance and its Important. Lakshmi Anusha, M. Aashritha, K. Teja and R. Sridhar
3. Accredited Consultants pvt.ltd info@acplgroupindia.co.in +919310040434
Reference