The objective of this paper is to outline pharmacovigilance (and related terms) and why it is important in drug discovery and healthcare

1. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
1
Define Pharmacovigilance. Explain the meaning
of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance
is important in drug discovery and healthcare
Fernanda Ferreira, f.lima22
Student of Advanced Post Graduate Diploma in Pharmacovigilance & Medical Writing,
James Lind Institute, Jul-2016
The objective of this paper is to outline pharmacovigilance (and related terms) and why it is
important in drug discovery and healthcare
Background
The World Health Organization (WHO)
defines Pharmacovigilance as the science and
activities relating to the detection, assessment,
understanding and prevention of adverse
effects or any other drug-related problem1
.
Recently, its concerns have been widened to
include:
• herbals
• traditional and complementary
medicines
• blood products
• biologicals
• medical devices
• vaccines 2
.
Over the past 50 years, pharmacovigilance has
evolved as an international initiative as well as
a scientific practice. The international
recognition of the pressing need for worldwide
collaboration on medicines safety monitoring
came about largely as a result of the
thalidomide tragedy in the early 1960s, in
which many thousands of congenitally
deformed infants were born as the result of in
uterus exposure to a medicine.7 Following this
tragedy, the Sixteenth World Health Assembly
in 1963 adopted a resolution (WHA 16.36)
that reaffirmed the need for early action with
regard to the rapid dissemination of
information on Adverse Drug Reaction
(ADR). This resolution led to the creation of
the WHO Pilot Research Project for
International Drug Monitoring in 1968, which
purpose was to develop an internationally-
applicable system for detecting previously
unknown or poorly understood adverse effects
of medicines. The initiative currently has 118
official member states, and 29 associate
member states 3
.
From these beginnings emerged the practice
and science of pharmacovigilance. Systems
were developed in Member States for the
collection of individual case histories of ADRs
and evaluation of them. The collection of
international ADR reports in a central
database, would serve the important function
of contributing to the work of national drug
regulatory authorities, improve the safety
profile of medicines, and help avoid further
disasters2
.
Important pharmacovigilance terms
• Adverse Event (AE)
Any untoward medical occurrence in a patient
or clinical investigation subject administered a
pharmaceutical product and which does not
necessarily have to have a causal relationship
with this treatment. An AE can therefore be
any unfavourable and unintended sign
(including an abnormal laboratory finding, for
example), symptom, or disease temporally
associated with the use of a medicinal product,
whether or not considered related to the
medicinal product4
.

2. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
2
• Adverse Drug Reaction (ADR)
A response which is noxious and unintended,
and which occurs at doses normally used in
humans for the prophylaxis, diagnosis, or
therapy of disease, or for the modification of
physiological function. (WHO, 1972). An
adverse drug reaction, contrary to an adverse
event, is characterized by the suspicion of a
causal relationship between the drug and the
occurrence, i.e. judged as being at least
possibly related to treatment by the reporting
or a reviewing health professional. In the
European Union (EU) Directive 2010/84,
which became applicable in July 2012 an
adverse reaction is defined as: A response to a
medicinal product which is noxious and
unintended5
.
• Serious adverse event (SAE)
An adverse event or suspected adverse
reaction is considered "serious" if, in the view
of either the investigator or sponsor, it results
in any of the following outcomes: Death, a
life-threatening adverse event, inpatient
hospitalization or prolongation of existing
hospitalization, a persistent or significant
incapacity or substantial disruption of the
ability to conduct normal life functions, or a
congenital anomaly/birth defect. Important
medical events that may not result in death, be
life-threatening, or require hospitalization may
be considered serious when, based upon
appropriate medical judgment, they may
jeopardize the patient or subject and may
require medical or surgical intervention to
prevent one of the outcomes listed in this
definition. Examples of such medical events
include allergic bronchospasm requiring
intensive treatment in an emergency room or at
home, blood dyscrasias or convulsions that do
not result in inpatient hospitalization, or the
development of drug dependency or drug
abuse6
.
The importance and objectives of
pharmacovigilance
Conceptually, pharmacovigilance is most
commonly thought of in terms of post-
marketing surveillance through ADRs
reporting and through so-called phase IV
clinical trials, however, pharmacovigilance is
actually an integral part of a biopharmaceutical
product’s entire life cycle, from clinical
development to the introduction of follow-on
generic products2
.
Therefore, pharmacovigilance is a much wider
practice than simply monitoring ADRs. In fact,
pharmacovigilance encompasses all the
aspects within a biopharmaceutical product or
technology’s life-cycle which concerns its
safety and quality. As such, an effective
pharmacovigilance system necessitates the
active involvement of regulatory authorities,
manufacturers and distributors, healthcare
institutions and professionals, as well as
patients3
.
The specific aims of pharmacovigilance are to:
• improve patient care and safety in relation to
the use of medicines and all medical and
paramedical interventions,
• improve public health and safety in relation
to the use of medicines,
• contribute to the assessment of benefit, harm,
effectiveness and risk of medicines,
encouraging their safe, rational and more
effective (including cost-effective) use, and
• promote understanding, education and
clinical training in pharmacovigilance and its
effective communication to the public2
.
In countries and regions such as the US, EU,
Japan, Canada and Australia,
pharmacovigilance is not a new concept but an
established and essential part of the drug
regulatory framework. However, even for the
most advanced drug regulatory authorities,
new gaps and challenges are constantly
emerging which necessitate closer attention, as
these gaps potentially pose patient safety and
public health concerns3
.
References
1. Pharmacovigilance. World Health
Organization website.
http://www.who.int/medicines/areas/qualit
y_safety/safety_efficacy/pharmvigi/en/.
Accessed on 07/28/16.

3. Define Pharmacovigilance. Explain the meaning of ADR, AE, and SAEs. On the basis of your own
internet research explain why pharmacovigilance is important in drug discovery and healthcare
3
2. The Importance of Pharmacovigilance -
Safety Monitoring of medicinal products.
Essential Medicines and Health Products
Information Portal - World Health
Organization.
apps.who.int/medicinedocs/pdf/s4893e/s48
93e.pdf. Accessed on 07/28/16.
3. Pugatch M, Torstensson D, Laufer M. The
Evolution of Pharmacovigilance -
Labeling, Packaging and Pharmacopeia
Standards. 2015; http://www.pugatch-
consilium.com/reports/The%20Evolution%
20of%20Pharmacovigilance.pdf.
Accessed on 07/28/16.
4. ICH Topic E2A Clinical Safety Data
Management: Definitions and Standards
for Expedited Reporting. European
Medicines Agency website.
http://www.ema.europa.eu/docs/en_GB/do
cument_library/Scientific_guideline/2009/
09/WC500002749.pdf. Accessed on
07/28/16.
5. Glossary of terms used in
Pharmacovigilance. World Health
Organization website. www.who-
umc.org/graphics/25301.pdf. Accessed on
07/28/16.
6. CFR - Code of Federal Regulations Title
21 - Sec. 312.32 IND safety reporting. US
FDA website.
http://www.accessdata.fda.gov/scripts/cdrh
/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32.
Accessed on 07/22/16.