Expediated Reporting

List of content
1. INTRODUCTION
2. EXPEDIATED REPORTING
3. STANDARDS FOR EXPEDIATD REPORTING
4. REPORTING TIME FRAMES
5. HOW TO REPORT?
6. KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OF

SERIOUS ADVERSE DRUG REACTIONS
7. IMPORTANCE OF EXPEDITED REPORTING IN PHARMACOVIGILANCE

1. INTRODUCTION
• International Council for Harmonization of Technical Requirements for Pharmaceuticals for
Human Use (ICH): A global organization that brings together regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of drug registration.
• Mission: To achieve greater harmonization to ensure that safe, effective, and high-quality
medicines are developed and registered efficiently.
• Accomplished through Technical Guidelines that are implemented by the regulatory authorities.
2. EXPEDIATED REPORTING
• An individual case safety report of one or more adverse events that must be submitted within a
specific amount of time due to the severity of events, is Expedited reporting.
• The purpose of expedited reporting is to make regulators, investigators, and other appropriate
people aware of new, important information on serious reactions.
• The following documents or circumstances will be used to determine whether an adverse
event/reaction is expected:
• For a medicinal product not yet approved for marketing in a country, a company's Investigator's
Brochure will serve as the source document in that country.
• Reports which add significant information on specificity or severity of a known, already
documented serious ADR constitute unexpected events.
3. STANDARDS FOR EXPEDIATD REPORTING

What Should be Reported?
a. Single Cases of Serious, Unexpected ADRs
 All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited
reporting. This applies to reports from spontaneous sources and from any type of clinical or
epidemiological investigation, independent of design or purpose. It also applies to cases not
reported directly to a sponsor or manufacturer (for example, those found in regulatory authority-
generated ADR registries or in publications). The source of a report (investigation, spontaneous,
other) should always be specified. Expedited reporting of reactions which are serious but
expected will ordinarily be inappropriate.
 Expedited reporting is also inappropriate for serious events from clinical investigations that are
considered not related to study product, whether the event is expected or not. Similarly, non-
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serious adverse reactions, whether expected or not, will ordinarily not be subject to expedited
reporting. Information obtained by a sponsor or manufacturer on serious, unexpected reports
from any source should be submitted on an expedited basis to appropriate regulatory authorities
if the minimum criteria for expedited reporting can be met.
 Causality assessment is required for clinical investigation cases. All cases judged by either the
reporting health care professional or the sponsor as having a reasonable suspected causal
relationship to the medicinal product qualify as ADRs. For purposes of reporting, adverse event
reports associated with marketed drugs (spontaneous reports) usually imply causality.
 Many terms and scales are in use to describe the degree of causality (attributability) between a
medicinal product and an event, such as certainly, definitely, probably, possibly or likely related
or not related. Phrases such as "plausible relationship," "suspected causality," or "causal
relationship cannot be ruled out" are also invoked to describe cause and effect. However, there is
currently no standard international nomenclature. The expression "reasonable causal
relationship" is meant to convey in general that there are facts (evidence) or arguments to suggest
a causal relationship.
b. Other Observations
 There are situations in addition to single case reports of "serious" adverse events or reactions that
may necessitate rapid communication to regulatory authorities; appropriate medical and scientific
judgement should be applied for each situation.
 Examples include:
• For an "expected," serious ADR, an increase in the rate of occurrence which is judged to be
clinically important.
• A significant hazard to the patient population, such as lack of efficacy with a medicinal
product used in treating life-threatening disease.
4. REPORTING TIME FRAMES
 Fatal or Life-Threatening
Unexpected ADRs Certain ADRs may be sufficiently alarming so as to require very rapid
notification to regulators in countries where the medicinal product or indication, formulation, or
population for the medicinal product are still not approved for marketing, because such reports
may lead to consideration of suspension of, or other limitations to, a clinical investigations
program. Fatal or life-threatening, unexpected ADRs occurring in clinical investigations qualify
for very rapid reporting. Regulatory agencies should be notified (e.g., by telephone, facsimile
transmission, or in writing) as soon as possible but no later than 7 calendar days after first
knowledge by the sponsor that a case qualifies, followed by as complete a report as possible
within 8 additional calendar days. This report must include an assessment of the importance and
implication of the findings, including relevant previous experience with the same or similar
medicinal products.
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 All Other Serious, Unexpected ADRs
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon
as possible but no later than 15 calendar days after first knowledge by the sponsor that the case
meets the minimum criteria for expedited reporting.
 Minimum criteria for reporting

Information for final description and evaluation of a case report may not be available within the
required time frames for reporting outlined above. Nevertheless, for regulatory purposes, initial
reports should be submitted within the prescribed time as long as the following minimum criteria
are met: an identifiable patient; a suspect medicinal product; an identifiable reporting source; and
an event or outcome that can be identified as serious and unexpected, and for which, in clinical
investigation cases, there is a reasonable suspected causal relationship. Follow-up information
should be actively sought and submitted as it becomes available.
Timeline for Expedited Reporting
5. HOW TO REPORT?
 The CIOMS-I form has been a widely accepted standard for expedited adverse event reporting.
However, no matter what the form or format used, it is important that certain basic
information/data elements, when available, be included with any expedited report, whether in a
tabular or narrative presentation.
 The listing in key data element addresses those data elements regarded as desirable; if all are not
available at the time of expedited reporting, efforts should be made to obtain them.
 All reports must be sent to those regulators or other official parties requiring them (as
appropriate for the local situation) in countries where the drug is under development.
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6. KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OF
SERIOUS ADVERSE DRUG REACTIONS
1. Patient Details
o Initials
o Other relevant identifier (clinical investigation number, for example)
o Gender
o Age and/or date of birth
o Weight
o Height
2. Suspected Medicinal Product(s)

o Brand name as reported
o International Non-Proprietary Name (INN)
o Batch number
o Indication(s) for which suspect medicinal product was prescribed or tested
o Dosage form and strength
o Daily dose and regimen (specify units - e.g., mg, ml, mg/kg)
o Route of administration
o Starting date and time of day
o Stopping date and time, or duration of treatment
3. Other Treatment(s)
o For concomitant medicinal products (including non-prescription/OTC medicinal
products) and non-medicinal product therapies, provide the same information as for the
suspected product.
4. Details of Suspected Adverse Drug Reaction(s)
o Full description of reaction(s) including body site and severity, as well as the criterion
(or criteria) for regarding the report as serious should be given. In addition to a
description of the reported signs and symptoms, whenever possible, attempts should be
made to establish a specific diagnosis for the reaction.
o Start date (and time) of onset of reaction
o Stop date (and time) or duration of reaction
o Dechallenge and rechallenge information
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o Setting (e.g., hospital, out-patient clinic, home, nursing home)
o Outcome: information on recovery and any sequelae; what specific tests and/or treatment
may have been required and their results; for a fatal outcome, cause of death and a comment
on its possible relationship to the suspected reaction should be provided. Any autopsy or
other post-mortem findings (including a coroner's report) should also be provided when
available.
o
5. Other information:
o anything relevant to facilitate assessment of the case, such as medical history including
allergy, drug or alcohol abuse; family history; findings from special investigations.
6. Details on Reporter of Event (Suspected ADR)
o Name
o Address
o Telephone number
o Profession (speciality)
7. IMPORTANCE OF EXPEDITED REPORTING IN

PHARMACOVIGILANCE
o Protecting public health
o Identifying new safety information
o Regulatory compliance
o Risk-Benefit evaluation
o Enhanced signal detection

Expediated Reporting

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3. STANDARDS FOR EXPEDIATD REPORTING

4. REPORTING TIME FRAMES

6. KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS OF

7. IMPORTANCE OF EXPEDITED REPORTING IN PHARMACOVIGILANCE

3. STANDARDS FOR EXPEDIATD REPORTING

4. REPORTING TIME FRAMES

 Minimum criteria for reporting

Timeline for Expedited Reporting

2. Suspected Medicinal Product(s)

7. IMPORTANCE OF EXPEDITED REPORTING IN

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