[Downloadedfreefromhttp://www.ijp-online.comonSaturday,February04,2012,IP:59.98.192.

9]||ClickheretodownloadfreeAndroidapplicationforthisjournal

Indian Journal of Pharmacology

ISSN 0253-7613

Official Publication of the Indian Pharmacological Society

February 2008

Vol 40

Supplement 1

CONTENTS

Editorial
Pharmacovigilance: Safety matters: Pipasha Biswas

S1

About our Guest Editor

S3

Review Article
Status of adverse drug reaction monitoring and pharmacovigilance in selected countries: Sachdev Yadav

S4

Pharmacovigilance of ayurvedic medicines in India: Urmila Thatte, Supriya Bhalerao

S10

Pharmacovigilance obligations of the pharmaceutical companies in India: Deepa Arora

S13

Importance of pharmacovigilance in Unani system of medicine: Syed Ziaur Rahman, Rahat Ali Khan, Abdul Latif

S17

Pharmacovigilance inspections: Patricia Fitzgerald

S21

How should you safely outsource pharmacovigilance to an Indian contract research organization?: Brian Edwards

S24

Pharmacovigilance training with focus on India: Sten Olsson

S28

Pleasures and pains of running a pharmacovigilance center: R.K. Dikshit, Chetna Desai, M.K. Desai

S31

The copies of the journal to members of the association are sent by ordinary post. The editorial board, association or publisher will not be responsible for
non-receipt of copies. If any of the members wish to receive the copies by registered post or courier, kindly contact the journals / publishers office. If a
copy returns due to incomplete, incorrect or changed address of a member on two consecutive occasions, the names of such members will be deleted
from the mailing list of the journal. Providing complete, correct and up-to-date address is the responsibility of the members. Copies are sent to subscribers
and members directly from the publishers address; it is illegal to acquire copies from any other source. If a copy is received for personal use as a member
of the association/society, one cannot resale or give-away the copy for commercial or library use.

S36

[Downloadedfreefromhttp://www.ijp-online.comonSaturday,February04,2012,IP:59.98.192.9]||ClickheretodownloadfreeAndroidapplicationforthisjournal

Review Article

Pharmacovigilance training with focus on India

Sten Olsson

As the worldwide movement for the improvement of patient safety gains momentum,
the subject of drug safety becomes even more prominent. Pharmacovigilance is the
science dedicated to reduce the risk of drug-related harms to patients. In India, as
elsewhere, the challenges and opportunities are substantial.
The Uppsala Monitoring Centre,
Uppsala, Sweden
Correspondence to:
Sten Olsson

The Burden of Drug-related Disease

Drug-related disease causes a considerable burden to healthcare systems around the
world. This has been clearly demonstrated in Western countries. A commonly quoted meta
analysis performed in the United States indicates that adverse drug reactions (ADRs)
were between the 4th and 6th most common cause of death in 1997.[1] Much less is known
about the situation in low-income countries. Published studies on the incidence and cost
of drug-related problems in developing countries are few. It is reasonable to assume
however that problems associated with drug therapy are more widespread in societies

with less rigorous control of drug quality, availability and

usage. One published study from Bosappa Memorial Hospital in
Mysore[2] confirms that drug-related adverse reactions may be
common in an Indian setting. Studies performed in developed
countries demonstrate that a majority of drug-related problems
are preventable.[3,4] If available instructions on how to use
medicines effectively and safely would be adhered to hospitals
in India would probably be relieved of hundreds of thousands
of patients, and society would save billions of rupees annually,
not mentioning the human suffering and the many thousands
of fatalities that would be avoided.
The lack of awareness in society about the magnitude of
drug-related problems is a mystery. Why is there no public
debate on how to reduce the injuries caused by medications
like there is for example regarding road traffic accidents.
One reason is probably that drug-related injuries are not
always obvious, immediate and visible. They often manifest
themselves gradually and with symptoms similar to those
caused by common diseases, sometimes while patients are
at home. The awareness of drug-related problems among
professionals, politicians, patients and the general public is
probably insufficient to trigger and stimulate a wide discussion
on how to reduce them. Is it the case that no player in the
healthcare system and supporting industry has an interest in
bringing these problems to the fore? Would society in general
and healthcare providers in particular lose the confidence of
patients if they knew how high the risk of injuries caused by
the healthcare system really is?
The Role of Pharmacovigilance
Pharmacovigilance is defined by the WHO as the science and
activities relating to the detection, assessment, understanding
and prevention of adverse effects or any other possible drugrelated problems.[5]
S28

Indian J Pharmacol

| February 2008 | Vol 40 | Supplement 1 | S28-S30

The role of pharmacovigilance can be divided into three

main areas:
To identify, quantify and document drug-related problems.
To contribute to reduce the risk of drug-related problems
in healthcare systems.
To increase knowledge and understanding of factors and
mechanisms which are responsible for drug-related injuries.
This wide remit for pharmacovigilance requires interactions
with and influence on many stakeholders in society with
decision-making powers affecting patient safety. For example:
Politicians at national, regional and local levels
Healthcare administrators
Drug Regulatory Authorities
Pharmaceutical companies
Healthcare professionals (physicians, dentists, pharmacists,
nurses, etc.)
Academic institutions
Media representatives
Health insurance companies
Lawyers
Patient groups
The general public including school children
Obviously, this range of stakeholders is in need of information
about drug-related risks at different levels in detail and with
different content. Pharmacovigilance training can therefore be
defined and described in many ways. This text is focusing on the
training of graduate professionals with an interest in learning
about pharmacovigilance methods, rather than learning about
how to use medicines more safely.
The Need for Pharmacovigilance Training
A new national network of pharmacovigilance centres
was established in India in 2004. The Central Drugs Standard
Control Organization (CDSCO) is coordinating the country-

[Downloadedfreefromhttp://www.ijp-online.comonSaturday,February04,2012,IP:59.98.192.9]||ClickheretodownloadfreeAndroidapplicationforthisjournal
Olsson: Pharmacovigilance training

wide pharmacovigilance programmes. It has established a

National Pharmacovigilance Advisory Committee to assist
with scientific advice on topical drug safety issues. Under the
national centre (CDSCO), the Indian pharmacovigilance system
is structured like a pyramid with peripheral centres reporting
to regional centres which in their turn will report to two zonal
centres who are responsible for keeping the main national
pharmacovigilance databases. The original structure had
some 50 pharmacovigilance centres involved, geographically
distributed over the whole of India.
To be effective, the introduction of a new network, with the
aim of collecting information from the healthcare system not
previously requested by authorities, would need an ambitious
training programme to be associated with it. Professionals
charged with the task of motivating their clinical colleagues to
fill in adverse reaction reports, process reports, analyze them,
draw conclusions and provide feedback have to receive at least a
minimum of training in the basic principles of pharmacovigilance
in order to be successful in their new role. This is particularly
true in a situation where pharmacovigilance centres are located
in academic institutions not directly interacting with patient care
or clinical practice. The need for training is continuous. There
will be a certain level of staff turnover in such a large system
and the need for specialist training in various sub-functions of
pharmacovigilance is constant.
In many disease-oriented Public Health Programmes (PHP),
large amounts of medicines or vaccines are distributed in the
population. PHPs often operate separately and in isolation
from the normal healthcare system that focuses on patient
care. It is rare for the programme manuals to contain any
aspect of drug safety follow-up when treatment outcomes are
being measured. This has to change. In several kinds of PHBs,
e.g., malaria, HIV/AIDS and immunization, new medicines
and vaccines are distributed to populations which have never
been used before. There is an evident need for an upgrading of
pharmacovigilance activities in many PHBs and this requires
training in methodology and data analysis.
The recent introduction of a legal requirement (schedule Y
amendment) for pharmaceutical companies to submit suspected
ADRs from clinical trials performed in India to the regulatory
authority have created a new demand for pharmacovigilance
competence in industry. Major companies are establishing
their own units for post-marketing safety surveillance, whereas
smaller companies are likely to turn to contract research
organizations (CROs) to assist them with pharmacovigilance
activities. The major multinational pharmaceutical companies
are also carrying out an increasing number of their phase
III and phase IV clinical trials in India, either managed by
themselves or by CROs. This trend drives another demand for
greater understanding about adverse reactions and methods
for their study. This is further increased by the requirement in
ICH countries for companies to submit risk management plans
in connection with submission of application for marketing
authorization of new medicines. Pharmaceutical industry is
required to have a life-cycle approach to their products and
patient safety issues associated with them.
Training in Pharmacovigilance
Pharmacovigilance is a relatively new and small science.

It is not a well-established academic specialism. Current

curricula in the training programmes of professions such as
clinical medicine, clinical pharmacy, clinical pharmacology
or medical biology do not cover all the skills needed in
pharmacovigilance. Very few universities in the world offer
specific courses in pharmacovigilance. One reason might
be that pharmacovigilance spans a wide range of subjects,
e.g., pharmacology, epidemiology, clinical medicine, data
management, drug legislation and communication, and they
do not easily fit within the competence area of any of the
existing academic departments. It is not to be expected that
pharmacovigilance will be taught as an academic subject at any
Indian university in the near future.
The International Society of Pharmacovigilance (ISoP)
is active in providing specialized ad hoc training courses in
pharmacovigilance. Also, the Indian chapter, the Society of
Pharmacovigilance India (SoPI), could become a provider of
regular pharmacovigilance training. SoPI is still a very small
organization, however, and would need a stronger base to
provide a credible and effective training service for the country
as a whole.
With a growing demand for pharmacovigilance training in
India, it is likely that various private initiatives will be taken
to meet this demand and profit from it. Although there are
knowledgeable and experienced pharmacovigilance experts
in India, they are still very few. Even if the existing experts
spent all their time on pharmacovigilance teaching, they
would still not be able to satisfy the need. Some providers
of pharmacovigilance training might be forced to bring in
pharmacovigilance experts from abroad or rely on a faculty
of less-qualified and less-experienced tutors. Bringing foreign
experts to India contributes seriously to high tuition fees, and
the foreign experts might not be very familiar with the context
in which patient safety monitoring has to operate in India. It will
be tempting for providers of pharmacovigilance training courses
to include persons with limited pharmacovigilance expertise
and experience in their faculty. For professionals wanting
pharmacovigilance training, it may become very important
to critically assess the quality of the training being offered by
various course providers.
Pharmacovigilance Training - The Content
All training has to be adapted to the needs of the trainees.
Since there are many different stakeholders in society with
a need for and an interest in pharmacovigilance, training
has to be offered at different levels, with different content
and given for different length of time. In basic curricula for
health professionals, a few hours of drug safety teaching is all
that can be hoped for. Health professionals in active service,
caring for patients in healthcare, might need a couple of days
of training on ADR mechanisms, reporting requirements
and patient management. Pharmacovigilance professionals
involved in data collection, processing and analysis should
have at least two weeks of basic pharmacovigilance training.
Apart from this, specific in-depth training in special sub-areas
has to be provided. Table 1 provides a framework of topics
that should be covered in a comprehensive pharmacovigilance
training programme. The borderlines of pharmacovigilance

Indian J Pharmacol

| February 2008 | Vol 40 | Supplement 1 | S28-S30

S29

[Downloadedfreefromhttp://www.ijp-online.comonSaturday,February04,2012,IP:59.98.192.9]||ClickheretodownloadfreeAndroidapplicationforthisjournal
Olsson: Pharmacovigilance training

Table 1
Outline of a general pharmacovigilance training programme
The need for and aims of pharmacovigilance
The burden of drug-related disease
Pre-clinical and clinical trials and their limitations
Definitions of key concepts
Historical development of pharmacovigilance
Drug-related problems in healthcare
Types and mechanisms of ADRs
Risk factors for ADRs
Drug-drug interactions
Other causes of drug-related problems
Drugs in pregnancy and lactation
Management of patients affected by ADRs
Medication errors
Clinical manifestations of ADRs
Review of drug-related diseases affecting different organ systems
The practice of spontaneous reporting
Organization
Setting up and running a pharmacovigilance centre
Patient reporting
Managing individual case safety reports (ICSR)
Terminologies
Feedback to reporters
Case assessment
Signal analysis and follow-up
Root-cause analysis of medication errors
Epidemiological methods
Drug utilization studies
Cohort event monitoring
Cohort studies
Case control studies

are not well defined and there are aspects of a patients

well-being during drug treatment that can extend beyond this
framework. Any pharmacovigilance programme being offered
is likely to focus on a sub-set of these topics. It is very rare
for any one individual to acquire full proficiency in all the
aspects of pharmacovigilance and patient safety monitoring.
Because of this fact, it is essential that experts in the various
sub-specialist areas work together for the protection of
patient safety.

Longitudinal databases of patient records

Regulatory requirements and international networking
The WHO global pharmacovigilance network
Responsibilities of marketing authorization holders
Expedited reporting, PSURs, risk management plans
Pharmacovigilance inspections
Literature sources for drug safety information
Special areas
Vaccine vigilance
Traditional medicines
Drug dependence
Unexpected lack of efficacy
Counterfeit medicines, drug resistance, interactions
Pharmacovigilance in Public Health Programmes
Ethics in pharmacovigilance
Benefit/harm assessment and decision making
Relative and absolute benefit/harm
Communicating drug risks and pharmacovigilance
Communicating with professionals and consumers
Labelling changes, bulletins, web sites
Interacting with media
Crisis planning and management
Promoting pharmacovigilance
Communication skills at all levels for all audiences
How to prevent drug-related problems from happening
Involving healthcare managers and health insurance companies
Rational and safe use of medicines
Professionals
Self-medication and the informal sector

knowledge and skills, pharmacovigilance can make an important

contribution to the health of the nation.
References
1.
2.
3.

Conclusion
Pharmacovigilance is a demanding science offering great
opportunities for reducing harm to patients and costs to
healthcare systems. From small beginnings, with the right

S30

Indian J Pharmacol

| February 2008 | Vol 40 | Supplement 1 | S28-S30

4.
5.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in

hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279:
1200-5.
Ramesh M, Pandit J, Parthasarathi G. Pharmacoepidemiol. Drug Saf 2003;12:
687-92.
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse
drug reactions as cause of admission to hospital: prospective analysis of 18 820
patients. BMJ 2004;329:15-9.
Winterstein AG, Sauer BC, Hepler CD, Poole C. Preventable drug-related hospital
admissions. Ann Pharmacother. 2002;36 (7-8):1238-48.
Anonymous. The importance of pharmacovigilance. Geneva: World Health
Organization; 2002.