ICP 1 ADVERSE DRUG EVENT S: MONITORING AND REPORTING
ABSTRACT : An adverse drug event (ADE) is an
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.
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,
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
ADRs 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
Providing updated drug safety
information to health care professionals
including WHO ADRs 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
Unexpected reactions regardless of their
nature or severity.
An observe increase in frequency of
ADE s occurring from overdose or
2. What information is required for an
ADE case report?
Adverse reaction description
Information related to suspected drug and its
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
Causality assessment and transmission of
assessed report to international drug
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
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
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
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
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Aditi Anand Apte, Reporting of adverse events
for marketed drugs: Need for strengthening
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Nahata, A Textbook of Clinical Pharmacy