1. A Pharmacovigilance audit is
important as it ensures the
company’s drug safety and risk
management procedures comply
with applicable laws, regulations
and guidance. While it could be a
daunting challenge at times to
comply with the existing
regulations, companies, large and
small, still must deal with this
reality as the organization’s
entire business operations could
not be put to risk of failing an
audit or inspection.
CHALLENGES IN ASIA
In Asia, there are a couple of
unique challenges that affect
pharmacovigilance (PV). In a
previous interview with Pharma
IQ, Dr Deepa Arora, a Physician
with more than 15 years of
experience and currently the
Global Head, Drug Safety &
Risk Management at Lupin
Limited, she identified some of
these challenges. Among them
are:
Poor availability of trained
manpower. The lack of
systematic material to learn about
pharmacovigilance is a major
issue faced in all sectors. The
situation is consistently
improving over the last few years
as some big projects have been
awarded by MNCs to BPOs
based in Asia; therefore, these
BPOs have hired and trained staff
in PV. Several institutes are also
offering training courses in PV
for beginners.
Expectations sometimes don’t
match reality. The
pharmaceutical industry in Asia
expects detailed guidance from
regulators and better
harmonisation of regulations for
pharmacovigilance. As
regulatory authorities don’t have
necessary manpower, this in turn
leads to poor implementation of
regulations, delays in planning
and regulatory action.
Safety of herbal drugs. The
safety of herbal drugs or allied
medicine-herbal and herbomineral drugs is a challenge more
specific to Asia than other
regions due to the extensive
usage of these drugs. Efforts are
on-going to define the
methodology for monitoring the
safety of such drugs. Several
regulatory-academia-industry
workshops have been organised
and extensive work has been
done in collaboration with WHO.
www.pharmacovigilanceasia.com

2. To mitigate the known and unknown challenges,
companies must establish robust drug safety and
risk management strategies that provide a
holistic point of view.
Poor reporting and poor quality
of spontaneous reports. Like
Western countries, challenges
faced by the industry in Asia
include poor reporting and poor
quality of spontaneous reports.
A lack of awareness regarding
PV amongst healthcare
professionals and consumers is a
major issue and probably the
most important target for
improvement, as growing
awareness amongst healthcare
professionals and consumers is
likely to result in a significant
improvement in overall
mplementation of PV by all
sectors, especially regulatory
authorities and Pharma industry.
Medication errors. Medication
errors are an important cause of
adverse reactions resulting in
significant morbidity and
mortality. Due to poor reporting,
it is quite difficult to estimate the
extent of medication errors in
Asian countries. Various forums
are being used to increase the
awareness of HCPs regarding the
importance of collection of ADR
data.
(Note: These responses are based on Dr. Arora’s
experience and opinion and may not reflect the
current processes followed at Lupin)
Understanding these challenges
is the first step in coming up with
effective strategies and plans
moving forward but this is not
enough.
drugs can still be withdrawn
from the market based on the
seriousness of the incidences and
its occurrence in many areas of
the world.
BUILDING A HOLISTIC RISK
MANAGEMENT PROGRAM
Patients are always looking for
the perfect drug, which gives
rapid cure, low cost, and with no
side effects. Pharmaceutical
companies from their side are
trying to overcome this challenge
which seems to be not so realistic
especially within a complicated,
highly competitive business, with
its social and political
implications.
To mitigate the known and
unknown challenges, companies
must establish robust drug safety
and risk management strategies
that provide a holistic point of
view, and not just dealing with
isolated issues or concerns. The
World Health Organization
(WHO) defines
Pharmacovigilance (PV) as “the
science and activities relating to
the detection, assessment,
understanding and prevention of
adverse effects or any other drugrelated problem.”
The pharmaceutical industries
manufacturing drugs are dealing
and treating human lives.
Consequently, it is considered a
special industry manufacturing
products (drugs) which need
special care and a significantly
higher safety standards than
those imposed on other
industries. As a result, even when
the incidence of adverse effects
(AEs) and signal detection is low,
The role of pharmaceutical
companies is to decide how to
manage the results of an AE
signal. Some drug companies
develop and prepare the safety
programs that are implemented
from the moment drugs enter
their product portfolio. Also,
collecting and analysing data in
an advanced way is an important
tool in drug safety and risk
management program. In this
concern, whatever the approach
selected, each program needs to
be reasonably relevant to the
nature of the risk. When a signal
of a potential side effect is
detected it should be
documented with its response.
www.pharmacovigilanceasia.com

3. 6 THINGS TO REMEMBER
The following recommendations could be taken in consideration to deal with the drug safety and risk
management. Others could be included based on pharmaceutical companies’ diversified strategies:
1
2
Review of previously conducted clinical trials.
Implement a signal monitoring program. This is a must to
determine as soon as possible any harm that evolved from
the drugs – either newly launched or already in market.
3
Regularly fill in the needed data in the PSURs (Periodic
Safety Update Reports) which is an important tool to follow
up and update worldwide the safety data of drugs.
4
Any signal detected should be carefully identified with
the adverse event that could potentially occur.
5
The validation of the signal and its analysis should be
done carefully considering the variable demographic
issues such as age and gender.
6
Randomised safety trials could be conducted by
pharmaceutical companies to implement information and
different education program to HCPs (Health Care
Professionals) and patients.
Learn practical tips to implement risk management, audit, inspection and
adverse drug reaction management strategies whilst complying to
regulatory requirements at the 4th Annual Pharmacovigilance Asia 2013.
To find out more, visit www.pharmacovigilanceasia.com
Disclaimer:
Please note that we do all we can to ensure accuracy and timeliness of the information presented herein but errors may still understandably occur in some cases. If you believe that
a serious inaccuracy has been made, please email darwin.mariano@iqpc.com.sg. This article is provided for information purposes only. IQPC accepts no responsibility whatsoever
for any direct or indirect losses arising from the use of this report or its contents.
www.pharmacovigilanceasia.com