Thesis grand

INTRODUCTION

“I firmly believe that if the whole materia medica could be

sunk to the bottom of the sea, it would be all the better for

mankind and all the worse for the fishes”. It is a broad term,

includes all kinds of noxious effects- trivial, serious or

even fatal. For the purposes of detecting and quantifying only

those adverse effects of a drug which are of some important

and occur in ordinary therapeutic setting, the term adverse

drug reaction (ADR) has been defined as any ‘any noxious

change which is suspected to be due to a drug, occurs at doses

normally used in man, requires treatment or decrease in dose

or indicates caution in the future use of the same drug’. This

definition excludes trivial or expected side effects and

poisonings or overdose.

“Pharmacovigilance”, As per World Health

Organization(WHO), “Pharmacoivigilance is the science and activities relating

to the detection, assessment, understanding and prevention of adverse effects or

any other drug related problems”. There is still a lack of

understanding on this topic like how it functions, what are

the benefits of sharing ADR knowledge and its purpose and

importance.2

The pharmacovigilance concept rests on three pillars:

i) Collecting new information from reliable

scientific resources such as marketing

authorization holders, healthcare

professionals, consumers, international/public

bodies, journals, published and updated

literature etc.

ii) Classifying and analyzing the above

information.

iii) Calculating its contents as well as any action

taken on specific drug to all health sectors.

United Kingdom

The yellow card scheme for reporting suspected adverse

drug reactions (ADRs) was

introduced in 1964 and over 400,000 reports have now been

received by the

Committee on Safety of Medicines (CSM) / Medicines and

Healthcare products

Regulatory Agency (MHRA).3

Japan

From the perspective of identifying concerns for future

pharmacovigilance in Japan, safety measures for recent Adverse

Drug Reactions (ADRs) are compared between Japan and the

United States of America (U.S.A.) and are classified into the

following three main categories: category one for cases in

which ADR problems have not become apparent due to “drug lag”

in Japan, category two for cases in which Japanese

idiosyncrasies have become apparent, and category three for

adverse events for which assessment of the causal relationship

is difficult..4

The Central Drugs Standard Control Organisation (CDSCO), New

Delhi, under the aegis of Ministry of Health & Family Welfare,

Government of India has initiated a nation-wide

pharmacovigilance programme in July, 2010, with the All India

Institute of Medical Sciences (AIIMS), New Delhi as the

National Coordinating Centre (NCC) for monitoring Adverse Drug

Reactions (ADR) in the country to safe-guard Public Health. In

year 2010, 22 ADR monitoring centres (AMCs) including AIIMS,

New Delhi had been set up under this Programme. To ensure

implementation of this programme in a more effective way, the

National Coordinating Centre was then shifted from the All

India Institute of Medical Sciences (AIIMS), New Delhi to the

Indian Pharmacopoeia Commission (IPC), Ghaziabad, (U.P.) in

April, 2011.4

Realising the importance of the task, Medical Council OfIndia

(MCI) has made it mandatory for all medical colleges to have

an adverse drug reaction training, monitoring and reporting

program. There is still a lack of understanding on this topic

like how it functions, what are the benefits of sharing

Adverse Drug Reaction knowledge and its purpose and

importance.5To fulfil the above aim it is important to find out

the perception of doctors about ADR reporting and identify

steps which will improve adverse drug reaction reporting and

fulfil the goal of MCI.

There have been a study conducted in South India on knowledge,

attitude and Practices of physicians regarding ADR monitoring

which showed the poor knowledge of health care professionals

towards ADR monitoring and positive effect on spontaneous

reporting after educational interventions.6

Keeping these facts in mind, this study will be conducted to

assess awareness of pharmacovigilance among the healthcare

professionals and to evaluate the impact of an educational

intervention for improving awareness of pharmacovigilance

among physician and nurses in an Indian peripheral care

teaching hospital.

Review Of Literature

Adverse drug reaction (ADR) has been defined as ‘any noxious

change which is suspected to be due to a drug, occurs at doses

normally used in man, requires treatment or decrease in dose or

indicates caution in the future use of the same drug. 6

Pharmacovigilance has been defined by the WHO as the ‘science

and activities relating to the detection, assessment,

understanding and prevention of adverse effects or any other

drug related problems. 7

The risk of ADRs is necessarily an inherent risk of all

drug therapy and is modulated by several factors, including

dose and frequency of administration, genotype, and

pharmacokinetic characteristics of special populations, such

as pediatric and geriatric patients and those with hepatic or

renal impairment. Due to the high frequency and potentially

serious consequences, ADRs may have a dramatic impact in

clinical practice both from a clinical and economic

perspective. 8

Clinical trials often lack important information about rare

but serious adverse drug reactions, chronic toxicity, use in

special groups (such as children, women, elderly or pregnant)

or interactions with other drugs. 9 Therefore, post-marketing

surveillance activities are important to allow the early

detection of unexpected and/or serious adverse reactions. 10The

use of drugs in randomized controlled trials (RCTs) is

according to strict protocols, often in patients who are not

frail and in a very controlled environment , which is very

unlike the use of drugs observed in the more dynamic clinical

settings where the mode and consequences of drug use can be

more complex.11 RCTs also cannot detect ADRs due to

inappropriate drug use. ADRs arising from inappropriate drug

use can be due to inappropriate drug dosage, or duration of

treatment, drug interactions, off-label use or use in

contraindicated circumstances11, 12 all of which can occur in the

general population or in a hospital setting. This risk of

inappropriate drug use is compounded by patients self

medicating with over the counter medications. Therefore, the

role of pharmacovigilance in detecting and quantifying ADRs

due to inappropriate medication use in a clinical setting is

particularly important because such ADRs are potentially

preventable.13

Patrick K.J Crowley and co-workers discovered that drugs may

interact directly with excipients or with residues or

impurities therein. Such interactions may be modest, slow and

take time to be detected in conventional stability studies.

This can complicate and even delay project progression. When

designing dosage forms therefore it is important to be aware of

the potential for excipients to adversely affect quality.14

Peter Mansell et. al opined that pharmacovigilance had tended

to be a backroom function in the pharmaceutical industry, and a

largely reactive one too. Patient safety and public health

should sit at the heart of corporate social responsibility.15

Economic burden due to adverse drug reactions

The impact and the management of ADRs is complex and in the

USA may cost up to 30.1 billion dollars annually. ADRs may

increase costs due to increased hospitalization, prolongation

of hospital stay and additional clinical investigations in

more

serious cases.16 In addition ADRs may trigger prescription

cascades when new medications are prescribed for conditions

that are a consequence of another medication, which is often

an

unrecognized ADR. Examples include the use of antipsychotics

in Parkinson’s disease patients treated with dopaminergic

drugs or the use of anticholinergic drugs for urinary

retention

in Alzheimer’s disease patients treated with cholinesterase

inhibitors.17 This increases the costs of pharmacotherapy as

well as compounding the risk of further ADRs.

Epidemiology of adverse drug reactions in clinical practice

Several epidemiological studies have been conducted that give

an indication of the frequency of ADRs and the related health

care costs in clinical practice.16 Such consequences include

drug-related hospital admission, prolongation of hospital

stay, and emergency department visits. Estimates from France

suggest that upto 123,000 patients a year present to their

general practitioner with an ADR.18

ADRs account for 4.2-30% of hospital admissions in the

USA and Canada, 5.7-18.8% of admissions in Australia, and 2.5-

10.6% of admissions in Europe.19

Some studies focused on more vulnerable population such as

the pediatric and geriatric patients. Between 2.1% and 5.2% of

ADRs in children lead to hospitalization, and up to 39% of

ADRs in pediatric patients can be life threatening or fatal.20

A national study from the USA estimated that 11.4-35.5% of

emergency department visits in older adults are due to drug

related causes.21Studies from Europe similarly found out that

up to 20% of ambulatory patients experience ADRs and

approximately 10-20% of geriatric hospital drug admissions are

due to drug related causes.22. 23 Another consequence of ADRs is

the prolongation of hospital stay.24 A prospective study showed

that ADRs increased the mean hospital stay from a mean of 8

days in patients without ADRs to 20 days in patients with

ADRs.25 Davies et al also found an increased risk of mortality

in patients who experienced an ADR compared with those who did

not.

A high frequency of ADRs is also seen in nursing homes, with

32-65% of ADRs occurring in these populations.25

In general the role of drug surveillance measures is

highlighted considering that between 32% and 69% of drug

related admissions were reported as definitely or possibly

preventable.26 Through these pharmacovigilance and active drug

monitoring studies, potential general a priori predictors of drug

related adverse reactions such as female sex, increasing age

and polytherapy have been identified. In addition, the type of

drugs most likely to result in ADRs and the most common type

of ADRs observed have also been characterized facilitating

their recognition and prevention.27,28,29

RISE OF PHARMACOVIGILANCE

Until the thalidomide tragedy in 1961, when the devastating

adverse effects of the drug came to light, the systematic

collection and analysis of adverse drug events had not

received much attention, although there are several examples

of systematic attention to the (negative) effects of drugs

that go further back.31 In his article on 150 years of

pharmacovigilance Philip Routledge refers to a committee that was

set up by The Lancet to collect reports on mortalities

resulting from anaesthesia in Britain and its colonies, the

results of which were published.32,33 The formation of the

committee was a reaction to the death of a 15 year old girl in

1848 who had undergone chloroform anaesthesia for surgery of

an ingrown toenail.31

In 1950, reports of incidences of aplastic anaemia associated

with the use of chloramphenicol were received in the US.34 This

led the Council on Drugs of the American Medical Association

to set up a Blood Dyscrasia Registry.35

DRUG SAFETY SINCE 1960

In 1961, the Australian physician McBride published a letter

in which he suggested a connection between congenital

malformations in newly born infants and the hypnotic

thalidomide, which was marketed under various names in many

countries.36 Earlier on 19 November 1961, at a conference on

pediatrics, the German physician Dr Lenz from Hamburg argued

that there was a correlation between the many births of

children with congenital deformities and the use of

thalidomide.31 On 25 November 1961, the manufacturer Chemie

Grunenthal withdrew thalidomide from the market.31 The number

of children born with serious congenital malformations as a

result of maternal use of thalidomide is estimated between

6,000 and 12,000, the majority of whom were born in

Germany.37,38

It is noteworthy in this context that today toxicology and the

surveillance of congenital abnormalities frequently fall

outside the scope of the national pharmacovigilance centres,

and have become the designated field of separate specialized

organizations.31

In 1961, the US FDA started with the systematic collection

of reports on all types of adverse drug reactions, chiefly

through the Hospital Reporting Program.31 In various countries

the thalidomide tragedy prompted the immediate formulation of

criteria that new drugs needed to meet to receive marketing

authorization, and which standards, apart from quality, also

emphasized the safety and efficacy of new drugs.31 In addition

the governmental marketing authorization organizations were

commissioned to establish a post marketing surveillance system

to facilitate the early detection of adverse reactions in

order to prevent a similar tragedy from occurring in the

future.31 In 1968, ten countries that supported a spontaneous

reporting system for adverse drug reactions took the decision

to collaborate and join the WHO Pilot Research Project for

International Drug Monitoring.39 In 1971, a resolution of the

Twentieth World Health Assembly laid the foundations for the

WHO International Drug Monitoring Programme.40 In 1972, a

report was published that formed the basis of the current

international system of national centres collaborating in the

WHO Programme. 41,42

The WHO International Drug Monitoring Programme is supported

and coordinated by the WHO Collaborating Center for

International Drug Monitoring (the UPPSALA Monitoring Centre),

which maintains and implements the international database of

adverse drug events. Its activities are of major importance

and include providing active support to the pharmacovigilance

centres in low income countries, and the evaluation and

augmentation of pharmacovigilance in general. In 2000, the

Guidelines for Setting Up and Running a Pharmacovigilance Centre

appeared and in 2002 the importance of Pharmacovigilance was

published under the auspices of the WHO, which lays the

foundation for the further theoretical and practical

implementation of pharmacovigilance on an international

scale .43,44

The Uppsala Monitoring Centre (UMC), located in Uppsala,

Sweden is the field name for the WHO Collaborating Centre for

International Drug Monitoring. The UMC works by collecting,

assessing and communicating information from member countries'

National Pharmacovigilance Programs in regards to the

benefits, harm, effectiveness and risks of drugs.45

The functions of UMC are as follows:

1. To co-ordinate the WHO Programme for International Drug

Monitoring and its more than 100 member countries

2. To collect, assess and communicate information from

member countries about the benefits, harms and risks of

drugs and other substances used in medicine to improve

patient therapy and public health worldwide

3. To collaborate with member countries in the development

and practice of the science of pharmacovigilance.

4. The main focus and source of data

in pharmacovigilance are reports of ICSRs (individual

case safety reports) from healthcare providers and

patients in member countries of the WHO Programme. A WHO

global individual case safety report database (Vigibase)

is maintained and developed on behalf of the WHO by the

UMC.46 The UMC develops and provides several tools and

classifications for use by organisations involved in drug

safety, including the WHO Drug Dictionary, WHO

ART (adverse reaction terminology) – with a bridge to

the MedDRA terminology, tools for searching in the

database, and a program for case report management,

VigiFlow.47

MedDRA or Medical Dictionary for Regulatory Activities is

a clinically validated international medical

terminologydictionary (and thesaurus) used by regulatory

authorities in the pharmaceutical industry during the

http://en.wikipedia.org/wiki/MedDRA

regulatory process, from pre-marketing to post-marketing

activities, and for data entry, retrieval, evaluation,

and presentation. In addition, it is the adverse

event classification dictionary endorsed by

the International Conference on Harmonisation of

Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH).48

5. The Uppsala centre has also published books in the field

of drugs safety including a regular newsletter.49

6. Training Programs for ADR monitoring and reporting.

Pharmacovigilance in world

There are differences between countries ( and also between

regions within countries ( and also between regions within

countries) in the occurrence of ADRs and other drug related

problems. This may be due to many factors such as :50

1. Diseases and prescribing practices

2. Genetics, Diet and traditions of the communities

3. Processes of drugs’ production influencing the quality of

the pharmaceutical composition;

4. Drugs, distribution and use including indications , doses

and availability.51

5. The use of traditional medicines and supplements (for

example, herbal remedies), which may constitute specific

toxicological problems. 52,53

The data resulting from the whole country or single region

may have greater relevance and educational value and may

affect the national regulations.51

According to the circumstances, the information obtained

in a country (for example, the country of origin of the drug )

may not be relevant in other ones.52

ADR Monitoring and Pharmacovigilance in Selected

Countries

Australia

In Australia, healthcare professionals, pharmaceutical

companies and consumers can report suspected adverse drug

reactions to the Adverse Drug Reactions Advisory

Committee

(ADRAC). Healthcare professionals usually submit reports

on

the 'blue card' which accompanies the Australian Adverse

Drug

Reactions Bulletin and the Schedule of Pharmaceutical

Benefits.

Reports can also be made by letter, fax or electronically

to

http://www.tga.gov.au/problem/index.htm#medicines . 54

USA

The FDA(Food and Drug Administration) Adverse Event

Reporting System (FAERS) is a database that contains

information on adverse event and medication error reports

submitted to FDA. The database is designed to support the

FDA's post-marketing safety surveillance program for drug

and therapeutic biologic products. The informatic

structure of the FAERS database adheres to the

international safety reporting guidance issued by the

International Conference on Harmonisation (ICH E2B).

Adverse events and medication errors are coded to terms

in the Medical Dictionary for Regulatory Activities

(MedDRA) terminology.55

http://www.tga.gov.au/problem/index.htm#medicines

Europe

The European Medicines Agency is responsible for the

development, maintenance and coordination of EudraVigilance, a

system designed for the reporting of suspected side effects.

Reports submitted to EudraVigilance include suspected side

effects of medicines reported during both the pre- and post-

authorisation phases. The system allows the detection of

signals of suspected side effects that were previously

unknown, and of new information on known side effects.

EudraVigilance data for centrally authorised medicines

are analysed on a regular basis, with a two-week or four-week

frequency.

The European Medicines Agency's Committee for Medicinal

Products for Human Use (CHMP) and Pharmacovigilance Working

Party (PRAC) evaluate signals from EudraVigilance and may

recommend regulatory action as a result. EudraVigilance is

used by national medicines regulatory authorities, the Agency

and pharmaceutical companies.56

United Kingdom

The yellow card scheme for reporting suspected adverse

drug reactions (ADRs) was

introduced in 1964 and over 400,000 reports have now been

received by the

Committee on Safety of Medicines (CSM) / Medicines and

Healthcare products

Regulatory Agency (MHRA). 57

Brazil

The National System Of Pharmacovigilance, managed

by the Pharmacovigilance Unit(PVU), is a part of the Health

Products Post-Marketting Surveillance Department (HPPMSD).58

Jordan

The Jordanian Pharmacovigilance Center (JPC) was

established in January 2001 in cooperation with Sweden

International Development Agency (SIDA) and Higher Council for

Science and Technology.59

Pharmacovigilance in India

India is a vast country with pharmaceutical industry

valued at $18 billion and growing at the rate of 12-14%

per annum and exporting nearly 40% of generic medicines

worldwide. India is also emerging rapidly as a hub for

global clinical research and a destination for drug

discovery and development with several outsourced

projects in pharmacovigilance. In addition, new chemical

entities (NCEs) are being introduced into the country ,

which is reflected by the increased total number of

applications received and processed that doubled, from

10,000 in 2005, to 22,806 in 2009 at Central Drugs

Standard Control Organization (CDSCO), headquarters at

New Delhi.60

History of Pharmacovigilance in India

In India, consideration of the surveillance of ADRs

developed relatively late, as traditionally there was no

concept of surveillance of medicines in the country. Even

though, pharmacovigilance is still in its infancy, it is

not new to India. It was not until 1986 when a few

physicians, mainly from academic institutions, called

for greater attention to be devoted to the potential

adverse effects of prescription medicines and rational

prescribing of medicines.60 This led to formation of first

ADR monitoring program consisting of 12 regional centers,

each covering a population of 50 million, but was

unsuccessful. 61

Nothing much happened until a decade later when in 1997,

India formally joined the WHO ADR monitoring Program

based in UPPSALA, Sweden. Three centers for ADR

monitoring were identified, mainly based on the teaching

hospitals: A National Pharmacovigilance Center located in

the Department of Pharmacology, All India Institute of

Medical Sciences (AIIMS), New Delhi and two WHO special

centers in Mumbai (KEM Hospital) and Aligarh (JLN

Hospital, Aligarh Muslim University). These centers were

to report ADRs to the drug regulatory authority of India.

The major role of these centers was to monitor ADRs of

medicines marketed in India. However, this attempt was

also unsuccessful as information about the need to report

ADRs and about the functions of these monitoring centers

never reached the prescribers and there was lacking of

funding from the government.

From 1 January 2005, the WHO sponsored and World

Bank funded National Pharmacovigilance Program (NPVP) for

India was made operational,62 its work being overseen by the

National Pharmacovigilance Advisory Committee based at CDSCO.

Two zonal centers-the South West Zonal center (located in the

Department Of Clinical Pharmacology, Seth G S Medical College,

KEM Hospital, Mumbai) and the North east Zonal center (located

in the Department of Pharmacology, AIIMS, New Delhi)- were to

collate information from all over the country and send it to

the committee as well to the UPPSALA Monitoring Centre in

Sweden. Three regional centers would report to the Mumbai

center and two to the New Delhi one.

The five regional centers were located at Kolkata (IPGMR-

SSKM hospitals), Mumbai (T N Medical College& BYL Nair

Charitable Hospital), Nagpur (Indira Gandhi Medical

College), New Delhi (Lady Hardings Medical College) and

Pondicherry (JIPMER). Each regional center, in turn,

would have several peripheral centers (24 in total)

reporting to it.

The program had three broad objectives:- The short term

objective was to foster a reporting culture, the

intermediate objective was to involve large number of

healthcare professionals (HCPs) in the system in

information dissemination, and the long term objective

was for the program to be a benchmark for global drug

monitoring. However, this program also failed.63

Recently, Medical Council of India has also made it

mandatory for

all medical colleges to have an adverse drug reaction

training,

monitoring and reporting program. There is still a lack

of

understanding on this topic, what are the

benefits of sharing Adverse Drug Reaction knowledge ,its

purpose and importance and how Pvg centre functions. To

fulfill the above aim it is

important to find out the perception of doctors about

adverse

drug reaction reporting and identify steps which will

improve

adverse drug reaction reporting and fulfill the goals of

Medical Council Of India

The Current PV Program in India

Recognizing the need to restart the NPVP, in a brainstorming

workshop jointly organized by the Department of Pharmacology,

AIIMS and CDSCO in late 2009, the framework of the new and

current program was formulated. The program, now rechristened

as the PharmacovigilanceProgramme for India (PvPI), was made

operational from mid July 2010.64 Initially Department of

Pharmacology at AIIMS was nominated as the National

Coordinating Centre (NCC), which was later on changed to the

Indian Pharmacopoeia Commission (IPC), Ghaziabad (U.P.). The

main aim of the NCC is to generate an independent data on the

safety of medicines, which will be at par with global drug

safety monitoring standards.

ADR Monitoring Centres (AMCs) under PvPI play a vital role of

collection and follow-up of ADR reports from the patients. They

are set up across India to collect the adverse event

information from patients. These AMCs are the Medical Council

of India (MCI) approved medical colleges & hospitals,

medical/central/autonomous institutes, public health programmes

and corporate hospitals. They are responsible for collecting

the adverse event information from the patients, performing

follow up with them to check the completeness of the ADR

reports as per Standard Operating Procedures (SOPs), entering

information in the prescribed software (Vigiflow) and sending

them to NCC via the same software. Some AMCs are also

responsible for providing training and technical support at

regional level.

The PvPI started with the enrolment of 22 ADR monitoring

centres across the country in the year 2010, which has

increased to 90 by the end of 2012, 60 of which are phase I

(FY2010-FY2011) AMCs and 30 are phase II (FY2012-FY2013) AMCs.

All the 90 AMCs are categorised into four zones i.e. North,

South, East and West as per zonal offices of CDSCO in India and

are functioning under NCC.

There are more than 2000 pharmacy colleges 90 Institute of

Pharm.D, more than 200 dental institutes, 360 MCI approved

medical colleges, and more than 320 nursing institutes all over

India. These institutes are associated with patients care by

providing safe and effective medication. For robust

pharmacovigilance, all of these colleges will be included as

ADR Monitoring Centres under this programme in the years to

come. 65

ROLE OF TRAINING IN ADR REPORTING

Several studies world wide have helped in justifying the need

for continuous training for spontaneous adverse drug reaction

reporting. Spontaneous ADRs reporting represents a precious

resource for control and information about the drug’s safety,

since it allows the detection of potential warning signals

related to the use of all drugs available in a country.66,67

In order to inculcate the culture of spontaneous adverse

drug reaction reporting amongst the physicians there is a

necessity to first test the Knowledge, Attitude and Practices

(KAP)of physicians regarding adverse drug reaction monitoring

and then to train the physicians accordingly. A number of

studies have been carried out to test KAP of health

professionals regarding ADR monitoring and subsequently impart

training sessions for the same.

A study conducted in Portugal included in its training

program a workshop intervention with sessions giving a brief

introduction about the problem of ADR and its impact on

public health, followed by an approach of spontaneous

reporting of ADR. It also conducted telephonic interviews.

Educational interventions conducted in workshops or

telephone interviews significantly increased the number and

relevance of spontaneous ADR reports by the pharmacists of

Northern Portugal.68

A study was conducted in Manipal, India which included an

educational intervention, both theoretical and practical, to

improve ADR reporting. The theoretical part consisted of a

presentation on how to report a suspected adverse drug

reaction followed by economic and epidemiological importance

of reporting the ADRs and its effect on patient safety, as

well as the definition of pharmacovigilance, classification of

ADRs (i.e. in terms of causality assessment, seriousness and

severity, ADR reporting cards from various countries, ADR

alert cards, WHO online database for reporting adverse drug

reactions).

The practical part involved the health care professionals in

filling up the ADR forms. This study also utilized KAP

questionnaire to assess the knowledge of health care

professionals regarding ADR reporting and Pvg. The result of

this study showed increased awareness of pharmacovigilance

among health care professionals.5

Mala Kharkhar , Suresh Bowalekar conducted a study in Mumbai

on knowledge, attitude and perception of doctors on ADR

monitoring by designing a questionnaire.The study revealed

that practitioners were aware of ADR reporting; their

perception toward ADR reporting was right but it did not

reflected when it came to the act of reporting of ADRs..69

MrinMoyChakrabarty,VijayThawani in their study showed ensuring

proper education and frequent updating of health care

professionals by training them in data collection, filtration,

mining, verification, interpretation and coding of ADRs,

medicines coding, causality assessment, signal detection, risk

management, and action in case of serious/fatal adverse drug

events (ADE).70

P.Ravishankar, P.Subish, P.Mishra, A.K. Dubey in their study

showed that the theoretical information of pharmacovigilance

programme was to be covered (preferably small group briefings)

of 1 hr duration each. The first two activities (designing a

reporting form, and carrying out a severity and causality

assessment of a given ADR report.was done in a problem based

learning session of 2 ½ hr duration. The visit to the

pharmacovigilance centre and the presentation and discussion

of findings can be done in the second session.71

In a study conducted by Antonio Vallano and co-workers,

the pharmacovigilance sessions were held during scheduled

staff sessions and lasted about 45 to 60 minutes to ensure

that the greatest number of physicians could be present. The

presentations were given by clinical pharmacologists and

divided into three parts. The first part included a review of

all identified and reported ADRs throughout the hospital

(number of cases, type and severity of ADR, type of drug)

between 1 January 2003 and 31 December 2005.

The second part included a review of identified and reported

ADRs in each specific medical department where the sessions

were held.The main features of the cases and their

contribution to the overall results of the Pharmacovigilance

programme (PhVP) were openly discussed.

The third part provided general information on

pharmacovigilance issues such as signals generated by the the

PhVP, news about ADR warnings released by regulatory agencies

(Spanish Agency of Medicinal and Health Care Products, the

European Medicines Agency, the U.S.Food and Drug

Administration, and others), or drug toxicity problems

identified by published studies in medical journals, and all

the topics were discussed openly.

The study concluded that additional studies on the

development and effectiveness of educational activities in

pharmacovigilance are necessary. 72

ChetnaK.Desai and co-workers in their study used a pretested

KAP questionnaire comprising of 15 questions. The study showed

that physicians were aware of the ADRs and the importance of

their reporting. However, under reporting and lack of

knowledge about the reporting system were clearly evident.73

Roald Gerritsen and co workers compared the lecture-

based pharmacovigilance training methods with the practice

based method by analysing the number and quality of reports

sent in by graduate GPs who had been offered one of both

approaches during their vocational training. The practice

based methods resulted in significantly more and better

documented reports and more often concerned unlabelled events

than the lecture-based method.74

Mariam Molokhia and co workers collected data sources from

Medline, Embase, Cochrane Library and National Library for

health searches on ADR reporting (January 1997 to August 2007)

including cross-referenced articles and showed that

educational interventions combined with reminders and/or

prescription card reports can improve hospital-based ADR

reporting.75\\

Subharti Medical College & Hospital is a five hundred bedded,

multispecialty teaching cum tertiary hospital of western U.P,

India. Department of Pharmacology of the institute was one of

the 24 peripheral Pharmacovigilance center under NPVP

established in 2005 and is also one of the Pvg centre under

current Pvg programme of India (PvPI). The department is

actively involved in ADR reporting and pharmacovigilance but

still ADR reporting by physicians and surgeons is dismal and

disappointing. Disheartened by the low rate of spontaneous ADR

reporting in our institute, the present study was planned to

re-establish the culture of ADR reporting and to test current

KAP of physicians, surgeons, residents, interns and nursing

staff about ADR reporting and Pharmacovigilance.

AIMS & OBJECTIVES

1. To study knowledge, attitude and practice (KAP) of

doctors and health professionals about adverse drug

reaction monitoring.

2. To identify measures that will help in better adverse

drug reaction reporting.

3. To impart training of adverse drug reaction monitoring.

4. To study impact of training on adverse drug reaction

reporting in CSSH of Subharti Medical College.

Material and Methods

Design

A cross sectional survey to evaluate KAP among doctors,

dentists and nurses followed by intervention in the form of

training and observe impact of training and recording of

adverse effects in patients attending outpatient department

and admitted in the CSSH of Subharti Medical college.

Setting & Population:

The survey was conducted in a CSSH attached with Subharti

Medical College (b) Subharti Dental College (c) private

practitioners working in Meerut d) Fortis Hospital

Training of adverse drug monitoring

Training in the form of lectures and practical use of tools

for adverse drug reactions was given to Doctors, Dentists

and Nurses working in Subharti Medical College

Tools

Questionnaire to elicit KAP

CDSCO form for reporting adverse effects

Tool for Causality of ADR

Tool for Preventability of ADR

Tool for Severity of ADR

ICD Classification for adverse drug reactions (Y 40-59

& T36-50)

Procedure

1 .A survey was conducted on doctors, nurses, dentists of

Subharti Medical College. The Knowledge Attitude and

Practices (KAP) questionnaires was distributed and filled

by them.

The private practitioners in and around Meerut were given

KAP forms to fill in periodic professional meetings and also

by post and electronic forms.

The forms to physicians and pharmacologists from other

medical colleges were given in conferences, professional

meetings and by electronic means.

Total sample size of survey would be 500 health care

professionals. The survey was done by getting the forms

filled physically and via electronic mode through internet.

2. Training program was conducted for health care

professionals. It included lectures to sensitize them about

need of adverse drug reaction reporting (ADR reporting) as

per MCI guidelines, its impact on economy. The participants

were explained about their obligations and responsibilities

towards ADR reporting when prescribing new drugs.

They were trained on use of CDSCO form, Subharti Medical

College outpatient (OPD) forms for ADR, Subharti Medical

College indoor IPD forms of ADR and categories of ADR

according to international classification of diseases (ICD).

Training was given about the use of World Health

organisation forms on causality, severity and

preventability. Training on causality, severity and

preventability assessment was given with the help of lecture

and practical exercise. Regular training program were

conducted at periodic intervals.

3. ADR forms were distributed in all OPD’s as well as in

wards. The filled forms were collected.The adverse drug

reactions were scrutinised and adverse effect of new drugs

as well as serious adverse effects were reported by filling

of adverse drug reaction form of CDSCO. The adverse drug

reaction during the study period of 1 ½ yrs were.

4. The adverse drug reaction form for admitted patients

were attached with the patients treatment file. It was

initiated by staff nurse on duty, verified by resident and

then confirmed by crosschecking. All patients file was

cleared after scrutinising for filling of the forms for

admitted patients.

Statistical Analysis

All data was tabulated as Mean ± standard error. Nominal

data was analysed by using chi square test, ordinal data was

analysed by using appropriate non parametric tests and

interval data was analysed by parametric test. Comparison

between different groups was done by unpaired t-test and for

paired observation paired t-test was applied. Analysis of

variance was done where number of observations or groups is

more than 2.

Ethical justification

MCI has made it mandatory for all medical colleges to

have adverse drug reaction training, monitoring and

reporting program. This project will help in fulfilling

MCI regulations

No drug, surgery or procedure is being performed.

Only a survey was done followed by training and

reporting of ADRs.

The privacy of the participating doctors was maintained

throughout the work.

RESULTS

1

Fortis(n=105)

Subharti(n=210)

LLRM(n=123)

PP(n=62)

0

100

200

105209

120 621

Type of ADR reporting form used by the physicians?

NonePreventabilitySeriousnessSeverityCausality

Institution Group

No. Of Responses

Fig:1

Consultants(n=152) JRs(n=304) Interns(n=44)0

50

100

150

200

250

300

350

1 11

150

303

431

NonePreventabilitySeriousnessSeverityCausality

Fig:2

As seen in the fig:1 only 1 out of 210 (0.6%) doctors ofSubharti institute was aware about the causality assessmentform of ADR reporting while 2 out of 123(1.6%) doctors of LLRMwere about of severity form of ADR reporting, 1 (.8%)doctor ofLLRM was aware about seriousness form of ADR and none of thedoctors in Fortis and private practitioners were about any ofthe ADR reporting forms.

Fig:2 shows that (0.6%) 1 out of 152 consultants were awareabout the severity tool of assessment ADR form, 0.6% ofconsultants were aware of seriousness tool of adr assessment.1 out of 304 (0.32%) JRs were aware about causality assessment

form and 1 (2.27%) out of 44 interns were aware about thecausality assessment ADR form.

Q.2

Fortis(n

=105)

Subharti

(n=210) LLRM

(n=123) PP(n

=62)

0

100

200

105209

91 62

1

32

Are the physicians aware about the ADR form of CDSCO?

YesNo

Institution Group

No. Of Responses

Figure:3


50100150200250300350

146278

43

6

26

1

Are you aware about the ADR reporting form of CDSCO?

YesNo

Participant Group

No of Responses

Figure:4

As see in Fig: amongst all the institutions, it was seen that32(26%) doctors of government institution LLRM were aware about the national CDSCO form of ADR reporting while only one(0.47%) of 210 doctors was aware about the CDSCO form. 100%doctors in Fortis and 100% private practitioners were aware about the CDSCO form.

Fig 4/ highlights the fact that 6 out of 152 (3.9%)consultantswere aware about the CDSCO form,26 out of 304 JRs(8.55%) were known to CDSCO form while only 1 out of 44(2.27%) intern was aware about the CDSCO form.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105201

88 62

9

35

Q3) Have the ADR reporting forms made available to you?

YesNo

Institution Group

No. of Responses

Fig:5


50100150200250300350

148273

44

4

31

Have the ADR reporting forms made available to you?

YesNo

Participant Group

Respondents

Fig:6

In Fig:5, it is seen that ADR reporting forms were available to 9 out of 210 (4.28%)doctors of Subharti, while 35 out of 123 (28.4%) doctors of LLRM were made available the ADR forms.100% of the doctors of Fortis and 100% private practitioners were not been given any ADR forms.

In Fig:6 4 out of 152(2.63%) consultants were been given the ADR forms, 31 out of 304(10.19%) JRs were made available with the ADR forms, while 100% of the interns got the ADR form.

Fortis(n

=105)

Subharti

(n=210)

LLRM(n=1

23) PP(n=62)

050

100150200250

105202

63 622

58

Q4) If Yes, which one?

NSNAWHOLocal/CDSCO

Institution Group

No. of Responses

Fig:7

Consultants JRs Interns0

50

100150

200250300350

1 1

143

253

44

8

40

If Yes, which one?

NSNAWHOLocal/CDSCO

Participant Group

Fig:8

Fig:7 shows that 8 out of 210(3.8%) doctors of Subharti were aware of local/CDSCO ADR forms, 2 doctors out of 123 doctors(1.62%) of LLRM were about WHO ADR form while100% physicians of Fortis and 100% private practitioners were not aware of any of the forms.

Fig:8 shows that 1 of 152(0.65%) consultant was aware of WHO ADR form, 1 out of 304 (0.32%)JRs was aware about local/CDSCO ADR form while 100% of the interns was aware of any of the ADRforms.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210 60

621944

Q5) Was the ADR reporting form too complex to fill?

NANoYes

Institution Group

No.of Responses

Fig:9


50100150200250300350

4 156 38142

251

44

Was the ADR reporting form too complex to fill?

NANoYes

Participant Group

No.of Responses

Fig:9 shows that 48% of LLRM physicians were not given the

forms while 35.77% of them did not find the form complex

15.44% of LLRM physicians found the form complex, shows the

significant difference in terms of complexity of forms, while

100% of physicians of Fortis, Subharti and private

practitioners were not even aware about the forms.

Fig:10 shows out of 152 consultants 4(2.63%) found the form complex while 6(3.94%) did not find the form complex, 93.4% ofconsultants did not know about the forms. Out of 304 JRs 15(4.93%) found the form complex while 38(12.5%) JRs did not find the form complex 82.56% of JRs were not aware about the forms. Interns were unaware about the form.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105210 109 62

Q6)Has any Medical Representative provided you with ADR reporting

form?

YesNo

Institution Group

No.of Responses

Fig:11


100

200

300

150292

44

2

12

Has ever any medical representative provided you with

ADR reporting form?

YesNo

Participant Group

No. of Responses

Fig:12

Fig :11 shows that only 14 out of 123(11.3%) doctors of LLRM were provided ADR reporting form by a medical representative. 100% Doctors of other institutions were not provided with ADR reporting forms by a medical representative.

Fig:12 shows that 2 out of 152(1.3%) consultants and 12 out of304(3.94%) JRs were provided with an ADR reporting form by a MR. While 100% interns did not get any ADR forms.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

150105 210 98 6225

Q7.) Has any medical representative informed you about

pharmacovigilance of a new product?

NoYes

Institution Group

No.of Responses

Fig:13


50

100

150

200

250

300

350

6 19

146

285

44

NoYes

Participant Group

No. of Responses

Fig:14

Fig 13 shows that LLRM is the only institute where 25 out of 123 (20.32%) doctors were informed about by MR about pharmacovigilance of a new product. 100% of the physicians of other institutions were not informed about pharmacovigilance of a new product.

Fig: 14 shows that 6 out of 152(3.94%) consultants and 19 out of 304 (6.25%)JRs were the ones who were informed about the pharmacovigilance of a new product by MR. 100% of the interns were not informed about pharmacovigilance of a new product.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

150105 209 99 621 24

Q8) Do the medical representative tell you that in case of new drug its safety has not been evaluated

in vulnerable population? NoYes

Institution Group

No.of Responses

Fig:15


200400

5 19 1147 28543

Do the medical representative tell you in case of new drug the

safety issues in pregnancy, lacttion, children, old age and concurrent renal/hepatic disease? No

Yes

Participant Group

Respondents

Fig:16

Fig: 15 highlights the fact that 1 out of 210(0.47%) doctors of Subharti and 25 out of 123(20.3%) doctors of LLRM were toldabout effects of new drug on vulnerable population, while 100%doctors of Fortis and 100% private practitioners were not informed about effects of new drug on vulnerable population.

Fig:16 shows that 5 out of 152(3.28%) consultants, 19 out of 304 (6.25%) JRs were informed. 2.27% of the interns were informed.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105209 82

621 41

Q(9)Do you think a new drug would be safe from ADRs as it has been

thoroughly evaluated?

YesNo

Institution Group

No. of Responses

Fig:17


100

200

300

19 22 1133

282

43

Do you think a new drug would be safe from ADRs as it has been

thorghly evaluated?

YesNo

Participant Group

Responses

Fig:18

Fig:17 shows that 41(33.3%) of doctors of LLRM and 0.47% of Subharti denies that new drug would be safe from ADRs. 100% ofthe doctors in Fortis, and 100% of the private practitioners believe that new drug would be safe from ADRs.

Fig:18 shows that 19 consultants(12.5%) , 22(7.2%) JRs and one(2.27%) intern denies that new drug would be safe from ADRs.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105209 84 621 39

Q10)Are you apprehensive of litigation/financial loss if you

would report an ADR?

NoYes

Institution Group

No. of Responses

Fig:19


50100150200250300350

9 29 1

143

274

43

Are you apprehensive of litigation if you report an ADR?

NoYes

Participant Group

No. of Responses

Fig:20

Fig:19 shows that only 1(0.47%) doctor of Subharti and 39(31.7%) doctors of LLRM were apprehensive of litigation charges if they would report an ADR.

Fig:20 shows that 9(5.9%) consultants, 29(9.5%) JRs and 2.27%of intern is apprehensive of litigation charges.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210 61

6241

21

Q.11) Are the training programs adequate or inadequate?

NANoYes

Institution Group

No. Of Responses

Fig:21


50100150200250300350

6 35140

254

44

6

15

Are the training programs adequate or inadequate?

NANoYes

Participant Group

No. of Responses

Fig:22

Fig:21 shows that 41(33.33%) doctors of LLRM considered training programs to be adequate while 17.07% were not aware about the training programs which shows that they had previously received pharmacovigilance training. 100% of the doctors of Fortis, Subharti and private practitioners found the training programs inadequate.

Fig:22 shows that 6(3.94%) consultants while 35(11.5%) JRs considered the training programs adequate. 100% of the internsfound the training programs inadequate.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105210 52

62566

Q12) Were You given repetitive training sessions on ADR

reporting?NANoYes

Institution Group

No. of Responses

Fig:23

Consultants JRs Interns0

50100150200250300350

1 413 53138

247

44

Were you given repetitive training sessions on ADR?

NANoYes

Participant Group

No. of Responses

Fig:24

Fig:23 shows 5 (4.06%) doctors of LLRM were given repetitive training sessions, 53.65% were not given repetitive training sessions in LLRM while 42.27% of the doctors in LLRM were not aware about the training sessions. 100% of the doctors in Subharti, Fortis and private practitioners did not know about the training sessions.

Fig:24 shows that 1(0.8%) consultant and 4 (1.31%)JRs were given repetitive training sessions. 100% of the interns were not given repetitive training sessions.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)

0100200

105210 96 62216

Q13) Is under reporting due to:a) lack of training, b) lack of time

c) BothBothLack of timeLack of regular training

Institution Group

No.of Responses

Fig:25

Consultant

s(n=152) JRs(n

=304)

Interns(n=

44)

050

100150200250300350

3 180 6149

280

44 BothLack of timeLack of regular training

Participant Group

No. ofResponses

Fig:26

Fig:25 highlights that 17.07% of doctors of LLRM consider lackof training to be the reason for under reporting, 4.87% doctors in LLRM consider lack of time to be the reason and 78.04% consider both lack of training and time to be the reasons for under reporting. !00% of the doctors in Fortis, Subharti and Private practitioners consider both the reasons for under reporting.

Fig 26 highlights the fact that 1.97% of the consultants consider lack of regular training training to be the reason for under reporting,98.02% of consultants take into account

both the factors for under reporting while 5.9% of JRs consider lack of regular training to be the reason for under reporting and 1.97% of the JRs consider lack of time to be thereason for under reporting, 92.1% of the JRs consider both thefactors reason for under reporting. 100% of the interns consider both the factors for under reporting.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105210

97 6226

Q14) Should postal/online facility be available for postage

of filled ADR forms

NoYes

Institution Group

No. of Responses

Fig:27


100

200

300

150280

44

2

24

Should postal/online facility be available for the postage of

filled ADR forms?

NoYes

Participant Group

No. of Responses

Fig:28

Fig:27 reveals that 78.8% of doctors in LLRM agree that postal/online services be available for ADR reporting, 21.1% disagrees with this. 100% of the doctors in Fortis, Subharti and of private practice agree that postal/online facility be available for ADR reporting.

Fig28 reveal that 1.31% of consultants disagree with availability of services, while 98.6% of consultants want to have these services. 7.8% of JRs don’t want such services, while 92.1% of JRs want such services. 100% of interns agree to such services.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210

112 6211

15) Is there a lack of law to implement it?

NoYes

Institution Group

Respondents

Fig:29


50100150200250300350

152

293

4411

Is there a lack of law to implement it?

NoYes

Participant Group

Respondents

Fig:30

Fig:29 highlights that 8.9% of doctors agree that there is a lack of law to implement ADR reporting while 91% disagree. 100% of the doctors in Fortis, Subharti and private practitioners disagree that there is a lack of law to implement ADR.

Fig 30 reveal that 3.6% of JRS agree that there is a lack of law to implement ADR reporting while 100% of consultants, 100%interns and 96.3% of JRs disagree that there is a lack of law to implement ADR reporting.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=12)

PP(n=6

2)

0

100

200

105210

85 6211

216

Q16) Do you think reporting is a professional obligation for you?

Series5PerhapsDon’t knowNoYes

Institution Group

No. ofr Responses

Fig:31


50

100

150

200

250

300

350

144

274

44

3

18

3

3

2

9

PerhapsDon’t knowNoYes

Fig:32

Fig:31 shows that 69.1% of doctors of LLRM, 100% of Fortis, 100% of Subharti and 100% private practitioners opine that they are professionally obliged to report an ADR.

Fig32 reveals that 94.7% of the consultants, 90.1% of JRs and100 % of interns believe that they are professionally obliged to report an ADR.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210

112 6211

Q17)Should ADR reporting be made a) compulsory b) voluntary

VoluntaryCompulsory

Institution Group

No. of Responses

Fig:33


50100150200250300350

151

302

44

1

10

Should ADR reporting be made: a) compulsory, b)voluntary

B A

Participant Group

No. of Responses

Fig:35

Fig34 shows that 91.0% of doctors in LLRM, 100% in Fortis, 100% in Subharti, and 100% private practitioners opine that ADR reporting should be made compulsory.

Fig35 reveals that 99.3% of the consultants, 96.7% of the JRs and 100% of interns agree that ADR reporting should be made compulsory.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210 99

6224

Q18)Do you get an ADR reporting bulletin/update?

NoYes

Institution Group

No. of Responses

Fig:36


100150200250300350

5 19

147

285

44

Do you get an ADR bulletin/update?

NoYes

Participant Group

update.

Fig:37

Fig 36 reveals that 80.4% of the doctors in LLRM, 100% of Subharti, 100% in Fortis and 100% of private practitioners do not get adverse drug reaction bulletin

Fig 37 shows that 96.7%consultants, while 93.7% JRs and 100%of interns do not get an ADR update/bulletin.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210

119 624

Q20) Is there a need for continuous medical education?

YesNo

Institution Group

No. of Responses

Fig:38


100150200250300350

150

302

44

2

2

Is there a need of continuous medical education?

NoYes

Participant Group

No. of Responses

Fig:39

Fig:38 96.7% doctors of LLRM, 100% of Fortis, 100% of Subhartiand 100% of private practitioners opine that there is need forcontinuous medical education.

Fig:39 highlights the fact that 98.6%, 99.3% JRs and 100% interns agree that continuous medical education is needed.

Fortis(n

=105)

Subharti

(n=123)

LLRM(n=1

23)PP(n

=62)

0

100

200

83 132 65 6222

7838911

Q21)Have you ever come across an ADR?

Not surePerhapsNoYes

Institution Group

Respondents

Fig:4079,62.8, 52.8, 100

Consultants(n=152)

JRs(n=304) Interns(n=44)0

50

100

150

200

250

300

350

135200

7

12

89

37

2

7

0

3

8

Not surePerhapsNoYes

Participant Group

No. of Responses

Fig 40 shows that 79% of doctors of Fortis,62.8% of Subharti, 52.8% of LLRM, and 100% private practitioners had come across an ADR.

Fig 41 shows 88.88% of consultants, 65.7% of JRs, 15.9% of interns came across an ADR.

Fortis

(n=105

)

subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100200

105210 91 6232

Is sufficient awareness created by print/electronic media for ADR

reporting?

NoYes

Institution Group

No.of Responses


100

200

300

5 27147

277

44

Is sufficient awareness created by print/electronic media for ADR

reporting?

NoYes

Participant Group

No. of Responses

Fig 42 shows 73.9% of doctors of LLRM, 100% of Fortis, 100% ofSubharti, 100% private practitioners opine that sufficient

awareness in not available byn print/electronic media about ADR reporting.

Fig 43 shows that 96.7% of Consultants, 91.1% of JRs and 100% interns opine that sufficient awareness is not created by print/electronic media.

Fortis

(n=105

)

Subhar

ti(n=2

10)

LLRM(n

=123)

PP(n=6

2)0

100

200

105210

123 62

Should consumers be informed about ADR of drugs?

NoYes

Institution Group

No.of Responses


50

100

150

200

250

300

350

152

304

44

NoYes

Participant Group

No.of Responses

Fig:44 shows that 100% of the doctors in LLRM, fortis, Subharti and private practitioners opine that consumers must be informed about ADR of drugs.

Fig 45 shows that 100% of Consultants, JRs and interns opine that consumers must be informed about ADR of drugs.

EFFECT OF TRAINING ON ADR REPORTING

During the course of 1 year of training sessions held in our institution positive outcomes were seen in the department of Psychiatry and Skin. From the Psychiatry dept 50 ADR reports were collected and from skin Department 60b ADR reports were collected.

DISCUSSION

Pharmacovigilance is still in its infancy in India. This has

led to lack of spontaneous adverse drug reaction reporting.

Lack of knowledge and education regarding importance of ADR

reporting play major roles in under reporting of ADRs. India

contributes only 2% overall ADRs to WHO in the world which is

a minute volume of the bulk. In the U.K., the number of ADR

reports has remained stable at 20,000 for the past 20 years.76

In Malaysia the number of reports has averaged at less than

2000 for the past 10 years.77 World wide, 95% of serious ADRs

do not get reported to health authorities78.

Majority of the physicians are not aware about the tools of

ADR assessment. Our study finds out that health care

professionals are unaware about the knowledge of

pharmacovigilance. This is supported by the study conducted in

Manipal where lack of knowledge of causality assessment tool

exists among the health care professionals.76

Almost all the physicians were unaware about the national

CDSCO form of India. We observed that doctors were less aware

of adverse drug reaction reporting systems. This is supported

by a study conducted by Madhan Ramesh et al.77 which stated

that doctors were less aware of the national and international

pharmacovigilance programs. Henceforth, the physicians did not

know whether the pattern of ADR reporting forms was complex or

easy.

The medical representatives did not provide adequate

information on pharmacovigilance of new product and its safety

concerns in vulnerable population. In a study by PipashaBiswas

et al,78 states that Pharmaceutical companies will need to show

both regulators and consumers that they are doing everything

possible to assure drug safety, while finding more effective,

while finding more effective approaches to manage drug safety

data. The companies need to be reassured that by reporting

adverse events and continuously monitoring for signals and

developing risk management plans for products. That is why

most of the physicians find a new drug to be safe from and

free from adverse drug reactions as they are not adequately

informed about the product.

From our study we found out that majority of doctors are not

apprehensive of litigation or financial loss if they would

report ADRs. This has proved to be a ray of hope towards

spontaneous adverse drug reaction reporting. If adequate

education is given to doctors then they would not be reluctant

to report ADRs. In a study conducted in Mumbai79, it states

that ignorance about the reporting is a major reason for under

reporting as compared to financial and legal aspects.

With regard to training of ADR reporting most of the doctors

have not attended any training sessions on pharmacovigilance

which highlights one of the causes for under reporting.

Studies80-82has shown that enhancing knowledge, attitude and

practice of improving awareness can increase the number of ADR

reports. Also a study conducted in Manipal76 reveals that

training and educational interventions markedly improved the

knowledge of pharmacovigilance among health care

professionals. Many studies have evaluated the effectiveness

of educational interventions aimed at increasing reporting

among physicians.83-87

Most of the doctors feel that there should be an online

facility for postage of filled ADR forms. This would make the

ADR reporting comparatively less tedious. In India an online

portal called “Vigiflow” is present through which all the AMCs

can report ADRs online. This is supported by some studies88-90

which state that in an era of established data and information

overload, medication administration and drug utilization are

significant factors in cost escalation, adverse outcomes, and

reduced quality in health care delivery. The availability and

use of large computerized clinical databases linked to

electronic medical records(EMR) now provide facilities for the

detection of adverse drug events and also the decision support

tools for clinicians to react appropriately to their

detection.

Majority of the doctors opine that there is no law which

compels the doctors for spontaneous ADR reporting. In a news

by CMAJ92 states that mandatory physician reporting of adverse

drug reactions could strengthen post market surveillance of

pharmaceuticals in Canada and provide an over haul of the

country’s “haphazard” drug safety database.A study by Kiran LJ

et al also found out thatcompulsory ADR reporting is important

in improving ADR reporting.93However, almost all the doctors

feel that they are professionally obliged to report ADRs.

Therefore if adequate training and sensitization of

pharmacovigilance is present implementation of law would not

be necessary. But the healthcare professionals do feel that

they should be compelled to fill ADR forms. Also, lack of time

and continuous medical education has led to under reporting

among the doctors. This was supported by the study conducted

by Chatterjee et.al92 which stated that a main reason for under

reporting of ADRs was the clinical negligibility of the

adverse reaction due to lack of time and little knowledge

about the types of reactions to be preferentially reported. In

the literature, a lack of time and knowledge about ADRs is

often considered to be a cause of under reporting.93-95Almost

all the doctors have encountered ADRs in their practice but

none of them have reported ADRs.The reasons for under

reporting of ADRs have been summarized by Inman96 as the “seven

deadly sins” . This includes financial incentives(rewards for

reporting), legal aspects(fear of litigation), complacency

(belief that the serious ADRs are already documented when a

drug is introduced in the market), diffidence(belief that

reporting should be done when there is certainty that the

reaction is caused by the use of a particular drug),

indifference (belief that a single report would make no

difference, ignorance (that only serious ADRs are to be

reported), lethargy (excuses about lack of time or

disinterestedness.

Majority of the doctors want consumers to be aware about the

adverse drug reactions of drugs. The IPC has a toll free

number for consumers in case patient suspects an adverse drug

reaction after consumption of a particular drug. In a study by

P. Ravishankar et al98 the health care professionals should

communicate the potential harm of drug-use to patients as a

matter of high priority. This would definitely contribute

towards effective ADR reporting in our country.

Despite the fact, that majority of the physicians lacked all

aspects (Knowledge, Attitude and Practices) of ADR monitoring

we found significant differences between the government

institution (LLRM) and private institutions(Subharti, Fortis

and private practitioners).Some of the doctors of LLRM were

known to the format of ADR reporting forms. Also significant

number of doctors of LLRM were informed about adverse drug

reactions by the medical representatives making it evident

that they are more interactive with medical representatives.

Our study showed that some of the doctors of LLRM have

undergone training for pharmacovigilance which we attribute to

the fact that when we contacted them retrospectively we found

out that they were given knowledge on pharmacovigilance in

their previous institutions

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