ICP1 Essay


ABSTRACT : An adverse drug event (ADE) is an

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injury resulting from medical intervention to a drug.

This includes medication error, adverse drug

reaction, allerg ic reactions and overdoses. ADE s

can happen anywhere in hospitals, long -term care

setting and outpatient setting. Adverse drug reaction

(ADR) is a part of adverse drug event . ADR is an

injury caused by taking medication. This can

happen following a single dose or result from the

combination of two or more drugs.

To overcome

from these ADR and ADE and to reduce the cases

the drug monitoring and reporting is done and

necessary. The monitoring basically means “to

observe and check the progress or quality of

something over a period of time and keep under

systematic review.” To overcome from ADE and

ADR the drug monitoring is require d. Adverse drug

monitoring is a systematic reporting and evaluation

of certain or all adverse reaction to drugs including

herbal drugs and vaccines .

Along with monitoring

the reporting is also required for specific

conclusion. The reporting specifically means

“giving a spoken or written account of something

that one has observed, heard, done, or

investigated.” In adverse drug reporting all

suspected adverse drug reactions should be reported

whether known or unknown, serious or not,

including minor once. This monitoring and

reporting of adverse drug event will reduce the no.

of incidence of adverse drug reaction.

An adverse drug event is an injury resulting from

medical intervention related to the drug. Thi s includes:

medication errors, allergic reactions,

overdoses etc.

Medication errors : A medication error is any

preventable event that may cause or lead to

inappropriate medication use or patient harm.

Eg; writing illegibly so that ‘Panadol’

(paracetamol) i s dispensed instead of Priadel


Allergic reactions : It is an extraordinary

response shown by a drug within a therapeutic

dose which is undesired or unwanted. Eg; small

quantity of quinine may cause ringing of ears.

Overdoses : It is consumption of drug in

unnecessary more quantity.

ADE s can h appen anywhere in hospital long –

term care settings and outpatient settings.

Adverse drug reaction is the part which comes

under adverse drug event.

ADR: It is defined as injury to body that is

caused by any other medication .

Classification of ADR:

On the basis of type of reaction:

• Type A: reaction which can be predicted

from the known pharmacology of the

drug, it is dose dependent. Common skill

management reduces this incidence. Eg;

anticoagul ant causes bleeding.

• Type B: these are predictable where the

mechanism is known otherwise

unpredictable for an individual, although

incidence may be known. It is dose

independent and rarely happens, these

accounts for most drug fatalities. Eg;

penicillin c auses anaphylaxis.

• Type C: reaction occur due to long time

exposure eg; analgesic neuropathy causes

dyskinesia with levodopa.

• Type D: occurs due to prolonged exposure.

It can happen due to accumulation of drug.

Eg; carcinogenesis or short term exposure at

critical time eg; teratogenesis.

• Type E: occurs on the withdrawal specially

when drug is stopped abruptly. Eg;

phenytoin withdrawal causes seizures.

Adverse drug reaction monitoring: It is a process

of continuously monitoring of unpredictable effect

suspec ted to be associated with the use of medicinal

products. It facilitates collection of unbiased safety

data observed during clinical practice in real life


The system of ADRs notification in Ta nzania is

centralized reporting whereby suspected case

rep orts of ADR are reported to CDSCO .

Objectives of ADR monitoring :

• To detect the nature and frequency of

ADR’s including periodic evaluation of

benefit risk ratio of medicinal products in

order to assist health professionals to take

appropriate actio n to minimize risk of

ADR’s •

Providing updated drug safety

information to health care professionals

including WHO ADR’s monitoring


• Dissemination of information by

design ing proper education programme

to consumer and other users

• Initiation of further studies for education


• To identify risk factors that may

predispose , induce or influence the

development, severity and incidence of

adverse reaction in population

Procedure for reporting ADE :

1. What to report?

This should include –

All ADE s as a result of prescription and

non- prescription.

Unexpected reactions regardless of their

nature or severity.

An observe increase in frequency of

given reaction.

ADE s occurring from overdose or

medication error.

2. What information is required for an

ADE case report?

Patient information

Adverse reaction description

Information related to suspected drug and its

adverse reaction

3. Who should report?

All health care professionals

Manufacturer of product registrants

All government hospital as well as priva te


4. Where to report?

Preferably directly to CDSCO by post or


5. How to obtain reporting form?

Website of CDSCO i.e. www.cdsco.nic.in

Regional hospitals, district hospital, ADR

focal person in hospital, clinics etc.

Processing of collected ADE data :

1. Assessment of ADE case report:

Quality of documentation

Analysis of relationship between drug and


Quality control in respect to identification of

duplicate report

Causality assessment and transmission of

assessed report to international drug

monitoring centres.

2. Handling of ADR data

Data should be stored in CDSCO for


The names of the reporter and patient will be

removed before any details about ADR are

use d.

Suspected ADR report cannot be use in a

court of law under any circumstances CDSCO

is responsible for providing,

reporting forms, collecting, analyzing

and evaluation of report.

3. Utilization of ADR:

Further investigation of signals eg; dose

range of the medicine, pharmacological

mechanism etc.

Drug regulation and dissemination of


Education and training initiative to

improve safe use of medication.

Pharmacovigilance : It is a n evolving

discipline in the Indian context.

Although a formal adverse event

monitoring system for reporting of

adverse events was suggested for India

in 1986, nothing much happened till

1997 when India joined World Health

Organization adverse event monitoring

program based in Uppsala, Sweden. A

form al national pharmacovigilance

program only started in India since

January 2005 and was based on the

hierarchy of peripheral, regional, and

zonal centers for collection of adverse

events that reported to Central Drug

Standard Control Organization

(CDSCO) an d Uppsala Monitoring

Centre. It was aimed to order to collect

and analyze safety data regarding a drug,

communicate associated risk to the

practicing physicians and general public and

arrive at regulatory intervention if necessary.

Since 2010, the program has been

reorganized as Pharmacovigilance

Programme of India (PvPI) in collaboration

with Indian Pharmacopoeia Commission,


Central Drugs Standard Control Organization

Directorate General of Health Services,

Ministry of Health & Family Welfare, Government

of India

FDA Bhawan, ITO Kotla Road, New Delhi –



Monitoring of adverse drug reactions started in

India about two decades ago (1982). Under the

chairmanship of the Drug Controller of India, five centres were established with the idea of starting

a monitoring programme nationwide. It

consisted of three pha

ses: the first one being

monitoring of reactions in the institutes, second

one in governmental bodies like CGHS, and the

third phase proposed to include general

practitioners. A multi- institutional pilot study

involving 58,194 cases was done in 1987 under

the aegis of Indian Council of Medical

Research. Its nodal centre (National

Pharmacovigilance Centre) is located in the

Department of Pharmacology, All India Institute

of Medical Sciences, New Delhi. It is affiliated

to WHO collaborating Centre for ADR

Monitoring, Uppsala, Sweden. The others are

located in PGI (Chandigarh), JIPMER

(Pondicherry), KGMC (Lucknow), and Seth GS

Medical College (Mumbai) – special centre. It

was envisaged to be a collaborative activity of

both clinicians and pharmacologists; now in

India, the pharmacologists with or without the

involvement of clinicians usually do it9.

Physicians, however, continue to play a

meaningful role in the entire monitoring

process, as the co -operation of the clinicians is

needed to have an access to the patient data and

at times in interpretation of the reports of

suspected advers e drug reactions. In many other

countries, the pharmacists or nurses usually

carry it out under supervision. They are

specially recruited for this purpose; physicians

and pharmacologists are involved in the

interpretation of the collected data or hypothesi s

testing on the basis of the reports. These workers

may involve a panel of the physicians in reviewing

all the collected reports. Though the pattern of

adverse reactions differs slightly from country to

country, adverse reactions to analgesics (mainly,

non- steroidal anti- inflammatory drugs) and

antibiotics constitute about ha lf of all such reports

in India . This may be partly due to the fact that

these are the most commonly used drugs in


Conclusion : Monitoring of adverse drug reactions

is an ongoing, ceaseless, and continuing process.

Though pharmacovigilance is still in its infancy in

India, this is likely to expand in the times to come.

Thus, it needs to be reinforced that

pharmacovigilance is a responsibility of all

including physician, nurse, pharmacist, drug

company, and the regulator. Development of more

solid programs, collaboration with private sector

and increased awareness among all stakeholders can

help us achieve a better pharmacovigilance system.

Also, for this, students (both undergraduates and

postgraduates) need to be trained in drug safety and

a habit of rational drug use should be inculcated in

them from the beginning. Continuing medical

education programmes for physicians and other

health professionals should be conducted to make

them aware of the methodologies and other

technical aspects of the drug monitoring process.

References : Vikas

Dhikav, Sindhu Singh, KS

Anand,Adverse drug reaction monitoring in

India, JIACM 2004; 5(1): 27- 33

Aditi Anand Apte, Reporting of adverse events

for marketed drugs: Need for strengthening

safety database, Perspectives in Clinical

Research2016, Jul-Sep; 7(3): 111–114


G Parthasarthi, Karin Nyfort -Hansen, Milap C

Nahata, A Textbook of Clinical Pharmacy

Practice, Orient Longman Private Ltd.

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