Spontenious Reporting System

SPONTENIOUS REPORTING SYSTEM
INTRODUCTION: When a drug is launched in the market not all of its adverse effects may be
known, thereby making post-marketing surveillance of drugs extremely important. An example
is that of cardiovascular events with rofecoxib, a drug which was indicated for the treatment of
osteoarthritis. After being marketed for 5 years and being used by millions of patients, the drug
was withdrawn as a result of the approved trial that showed a doubling of risk of myocardial
infarctions and ischemic cerebrovascular events in patients taking rofecoxib as compared to
those taking placebo. The World Health Organization (WHO) defines pharmacovigilance as “the
science and activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other possible drug-related problems”. The science is essential for
maintaining optimal risk–benefit profile of marketed drugs and hence for safeguarding public
health.
SPONTENIOUS REPORTING SYSTEM: When a physician suspects a serious clinical event to

be an ADR, they are encouraged to complete a questionnaire and notify the country’s drug
regulatory agency about the suspected ADR. An adverse event is serious when it results in death,
is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. In
some countries, the spontaneous reporting scheme has been extended to reporting from
pharmacists, nurses, and even patients.
Although the spontaneous reporting questionnaire differs from country to country, in general
the information collected includes patient details (such as age, sex, weight), details on the
suspected drug (such as dose, duration of treatment), details on the suspected reaction(s) (such
as description of the event, seriousness, outcome), medical history of the patient, and other
concomitant medication that the patient was taking. Examples of spontaneous reporting systems
include the “Yellow card scheme” operated by the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) and the Commission on Human Medicines, and the Adverse Event
Reporting System (AERS) which is a database of spontaneous reports received by the US Food
and Drug Administration (FDA) through the MedWatch form. In India the suspected ADR
reporting scheme is undertaken by the Central Drugs Standard Control Organization (CDSCO).
STRENGTH AND WEAKNESS: The spontaneous reporting system is a widely used, effective,
and relatively inexpensive method of collecting information on suspected ADRs. Its main function
is the detection of new, rare, and serious ADRs (6), which remained undetected in the pre-
marketing clinical trials. Spontaneous reporting operates throughout a drug’s life, starting from
the day it is launched in the market. The system also merits from the fact that it provides
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information from real-life clinical practice as opposed to clinical trials where vulnerable
individuals are excluded and the duration of treatment is limited.
However, the spontaneous reporting system has a number of shortcomings, under-reporting

being one of the major ones; this is discussed in detail below. Another weakness of the system is
that it only provides a numerator; information on population exposed to the drug is lacking.
Therefore, the risk associated with a drug is difficult to quantify accurately. Moreover, the
numerator is also subject to reporting bias (6,7). Other weaknesses include variations in the
quality of information provided and missing data.
UNDERREPORTING AND METHODS TO IMPROVING REPORTING: The spontaneous

reporting system is a passive surveillance method that solely relies on the healthcare
professionals to detect and take the initiative to report an ADR. Reporting varies with the
reporters’ skill and experience to detect the ADR, their level of understanding of the spontaneous
reporting system, and their workload (7). Furthermore, ADR reporting is also influenced by other
factors such as the media, published literature, and age of the drug. A higher number of reports
are seen in the first two years after drug launch.
DATA MONITORING TECHNIQUES: As the pharmaceutical industries and regulatory bodies

receive a large number of spontaneous reports each year, their databases are often large and
complex; consequently a case-by-case analysis becomes extremely time-consuming and
inefficient. This has lead to the development of statistical tools, known as data mining algorithms
(DMAs) to discern meaningful drug safety signals from the background “noise” within large
databases. The CIOMS VI working group defines a signal as “a report of any event with an
unknown causal relationship to treatment that is recognized as worthy of further exploration and
continued surveillance”. Data-mining tools act as a quick method for screening these large
databases which then help in hypothesis generation and prioritization of safety issues.
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CONCLUSION: Post-marketing safety surveillance of drugs is essential as not all adverse effects
of a drug may be identified from pre-marketing clinical trials. The spontaneous reporting system
plays an important role in pharmacovigilance by providing information from real-life clinical
setting throughout the life of a drug. Physicians and other healthcare professionals can
contribute immensely to improving public health by reporting suspected ADRs. Although
limitations such as under-reporting of ADR exists, reporting can be improved by education and
training of healthcare professionals. A number of statistical tools are being tested for efficient
signal detection in pharmacovigilance. These tools have to be used cautiously and in conjunction
with other methods of causality assessment.
REFERENCE:
1. Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C,
Riddell R, Morton D, Lanas A, Konstam MA, Baron JA. Cardiovascular events
associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl
J Med. 2005; 352(11):1092–102.
2. World Health Organisation Collaborating Centre for International Drug
Monitoring. The Importance of Pharmacovigilance, WHO 2002. Available from:
http://www.who-umc.org
3. European Medicines Agency. ICH Topic E2A. Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting. June 1995.
4. Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in
the United States, 1969–2001. The importance of reporting suspected reactions.
Arch Intern Med. 2005; 165:1363–9.
5. Mann R, Andrews E (ed). Pharmacovigilance, ed 2. Chichester: Wiley, 2007.
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SPONTENIOUS REPORTING SYSTEM

SPONTENIOUS REPORTING SYSTEM: When a physician suspects a serious clinical event to

However, the spontaneous reporting system has a number of shortcomings, under-reporting

UNDERREPORTING AND METHODS TO IMPROVING REPORTING: The spontaneous

DATA MONITORING TECHNIQUES: As the pharmaceutical industries and regulatory bodies

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