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Spontaneous reporting involves the voluntary reporting of adverse drug events to regulatory agencies like the FDA. It allows for early detection of unknown drug safety issues. The FDA relies on both mandatory reports from manufacturers and voluntary reports from healthcare providers and consumers through programs like Medwatch. While spontaneous reporting provides a large-scale, cost-effective means of signal generation, it also has weaknesses like underreporting, adverse event misclassification, and lack of denominator data on population exposure.

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94 views15 pages

SP

Spontaneous reporting involves the voluntary reporting of adverse drug events to regulatory agencies like the FDA. It allows for early detection of unknown drug safety issues. The FDA relies on both mandatory reports from manufacturers and voluntary reports from healthcare providers and consumers through programs like Medwatch. While spontaneous reporting provides a large-scale, cost-effective means of signal generation, it also has weaknesses like underreporting, adverse event misclassification, and lack of denominator data on population exposure.

Uploaded by

chandru sahana
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© © All Rights Reserved
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SPONTANEOUS REPORTING

INTRODUCTION
• In order to ensure that safe and effective
pharmaceuticals are available, the FDA relies on
both voluntary and mandatory reporting of adverse
drug events.
• All unsolicited reports from healthcare
professionals or consumers, received by the
FDA via voluntary or mandatory route are
called spontaneous reports.
• It is a clinical observation that originates outside of
a formal study.
• The individual spontaneous reports of ADRs,
medication errors and product quality problems are
sent directly through MEDWATCH program or
indirectly through manufacturers.
HISTORY OF PHARMACEUTICAL SAFETY
REGULATIONS
• The FDA is the first US consumer protection
agency. Its predecessor , THE BUREAU OF
DRUGS was established in order to implement
the Biologics Control Act 1902
• The Pure Food and Drug Act of 1906 prohibited
the interstate commerce of mislabeled and
adulterated drugs and foods.
• In 1934, Investigations on foods containing
dinitrophenol a component in diet preparations
that increase the metabolic rate to dangerous
level and responsible for many deaths.
• In 1937,Use of sulphanilamide elixir which is an
oral dosage used an untested solvent diethylene
glycol that resulted in 107 deaths.
• In 1952, Case of Aplastic Anemia or other blood
dyscrasias attributed to chloramphenicol.
• By 1967,the FDA started computerizing the data.
REGULATORY REPORTING
REQUIREMENTS

• In the US, AE reporting by individual healthcare


providers is voluntary. Manufacturers, packers
and distributors of FDA approved
pharmaceuticals have mandatory reporting.
 CURRENT REQUIREMENTS
• Main objective of FDA post marketing reporting
requirement is to provide early signal detection
about serious unknown drug effects.
DATA COLLECTION : THE MEDWATCH
PROGRAM
• The FDA encourages all healthcare professionals to
consider the reporting of AE as part of their
professional responsibility.
 FOUR GOALS
• Increase awareness of drug ,device and other
medical product induced disease and the
importance of reporting.
• It is to clarify what should be reported. it should be
limited to serious ADRs.
• It is to make it convenient and simple to submit a
report of the serious AE, medication error, product
quality problems directly to the FDA.
• To provide timely and clinically useful safety and
information on all FDA regulated medical
products to health care professionals and their
patients.
SAFETY ASSESSMENT:AE REPORTING
SYSTEM
It is designed and implemented with the following
concept in mind.
 Friendly screen layout and help function
 Enhanced search capabilities, quality control
features and electronic review of reports
 Improve the operational efficiency ,effectiveness
and quality control of the process for handling
AEs
 Implement and maintain compatibility with ICH
standards.
• Build the capability to receive electronic
submissions of AEs using ICH standards.
 Safety evaluators have the following
pharmacovigilance tools available for
AE report screening to generate signals:
I. Primary triage
II. Secondary triage/surveillance
III. Periodic reports
IV. Active query
DEFINITION OF TERMS USED IN FDA
 ADVERSE EXPERIENCE – Any adverse
event associated with the use of a drug or
biologic product in humans.
It may occur due to :
• overdose of the product; accidental or
intentional.
• Abuse of the product
• Withdrawal of the product
 UNEXPECTED ADVERSE EXPERIENCE –
Any AE that may be symptomatically and
pathophysiologically related to an event listed in
the labelling.
 SERIOUS ADVERSE EXPERIENCE : Any
AE occuring at any dose that results in death , a
life threatening AE, inpatient hospitalization or
prolongation of existing hospitalization, a
significant disability or birth defect.
STRENGTH
• Large scale and cost effective
• Generation of hypothesis and signals
• Opportunity for clinical contributors
WEAKNESS
• Adverse event recognition
• Underreporting
• Biases
• Estimation of population exposure
• Report quality
REFERENCE
• Textbook of Pharmacoepidomology
Saad A W Shakir
Page No : 165-168
• www.drsu.org

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