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®
MedDRA
Processing of Adverse Event Reports in ADE Surveillance Systems
Amarilys Vega, M.D, M.P.H., Sonja Brajovic, M.D., Jung Lee, RPh, Mark Vieder, RPh., Bane Bradic, M.D., PSI International, Inc., USA
Objective: To describe the application of the Medical Dictionary for Regulatory Activities terminology (MedDRA® ) in the drug safety surveillance process by providing an overview of the different phases of this process and
examples of surveillance systems that employ MedDRA® .
Drug Safety Surveillance Process Overview
Data Collection, Entry, and
Storage
Safety Signal Generation
Develop and implement coding and quality control guidelines
Reconcile and compare clinical trials and postmarketing safety data
Search organization’s safety data and data from other sources for
potential signals (i.e., data mining)
Collect, enter, and store in
database detailed safety data
obtained from all possible venues
Actions
Safety Signal Evaluation
Data Coding and Coding Quality Control
Descriptive Epidemiology
Describe and summarize all available information
pertaining to the adverse event of interest and the
suspect product
Analytic Epidemiology
Verify identified safety signals by
means of observational and/or
experimental epidemiological studies
Assess clinical
relevance of safety
signal
Take the necessary
steps to improve drug
safety
MedDRA® Application and Challenges
Collected data must be as
complete and detailed as
possible to facilitate clinical
interpretation, MedDRA®
coding, and data retrieval
and analysis.
Coding Guidelines and Coding Practices:
Impact on the Accuracy, Consistency & Uniformity in MedDRA® Coding
Example of an Adverse Event Narrative
A patient started a new antibiotic for the treatment of a complicated urinary tract infection 3 days ago.
He took a double dose last night by mistake. Today he reports markedly increased blood glucose with
high urinary glucose. Prior to this, the patient has been stable on once daily oral anti-diabetics.
Duplicate reports and follow
up data must be carefully
handled.
Employ information
technology tools that will
support this phase as well as
other phases of the Drug
Safety Surveillance process.
MedDRA®
Clinical Trials
Data
MedDRA®
Conversion
Clinical Trials
Data
MedDRA®
Coded Data
This process should be guided by the ICH endorsed
Term Selection: Points to Consider document and the organization’s specific objectives
Coding*
Coding*
Create a “Case Definition”
Using MedDRA® Terms
Coded in Other
Terminologies
Organization's Specific Coding Guidelines
by Organization A
1. LLT Incorrect dose administered
PT Incorrect dose administered
SOC Injury, Poisoning and Procedural
Complications
2. LLT Loss of control of blood sugar
PT Diabetes mellitus inadequate control
SOC Endocrine Disorders/
SOC Metabolism and Nutrition Disorders
by Organization B
1. LLT Incorrect dose administered
PT Incorrect dose administered
SOC Injury, Poisoning and Procedural
Complications
2. LLT Blood glucose increased
PT Blood glucose increased
SOC Investigations
3. LLT Glucose urine high
PT Glucose urine present
SOC Investigations
4. LLT Medication Error
PT Medication Error
SOC Injury, Poisoning and Procedural
Complications
Coding*
by Organization C
1. LLT Incorrect dose administered
PT Incorrect dose administered
SOC Injury, Poisoning and Procedural
Complications
2. LLT Diabetes mellitus aggravated
PT Diabetes mellitus
SOC Endocrine Disorders/
SOC Metabolism and Nutrition
Disorders
Identify cases of interest
in large external databases
Other Sources of
Safety Data
+
Organization’s
Postmarketing
Safety Data
+
Clinical Trials
Data
Compare data from these sources and determine
which combination of MedDRA® terms suggest a
potential safety signal for a particular product
(other standard terminologies are
bridged to MedDRA® )
Other Sources
of Safety Data
Organization’s
Safety Data
(i.e., medical literature, WHO)
+
Data Retrieval
Experimental
Studies
Create a Case Series
Case 1
Case 2
Case 3
Case 4
Case n
Clinical assessment
Summarize
all case
information
Enhance
dataset
by abstracting
additional
information
Observational
Studies
Obtain
disease
natural history
data
Obtain
adverse
event’s typical
characteristics
data
Descriptive
Epidemiology Studies
In-depth analysis
•Regulatory actions
Develop productspecific Risk
Management plan
 Assess safety issue’s
impact on patient
support and disease
management
programs
•Assess impact on
product marketing
•Make
recommendations on
how to improve
MedDRA®
Terminology
Verify Safety Signal
When possible,
code in MedDRA®
Examples of ADE Surveillance Systems
FDA AERS
(Food and Drug Administration
Adverse Event Reporting System)
Passive surveillance system which collects
spontaneous adverse event data
submitted by manufacturers and directly
by consumers and health professionals.
NEISS-CADES
(National Electronic Injury Surveillance System -Cooperative
Adverse Drug Event Surveillance)*
Active surveillance system which collects
adverse reaction data from patients’
records in a nationally representative
sample of hospital emergency rooms.
VHA PBM ADE Program
( Veterans Health Administration Pharmacy Benefits
Management Adverse Drug Event Database)
Passive surveillance system which collects
spontaneous adverse event data from all
VA medical centers and is managed by the
PBM VHA office
Coding guidelines developed based on ICH endorsed MedDRA® Term Selection: Points to Consider document and FDA’s
coding principles.
The goal is to capture medical concepts described in the narrative and translate them into suitable MedDRA® terms.
Coding guidelines and practices are regularly reevaluated and modified according to FDA’s needs and requirements.
MedDRA® coding accuracy is monitored by a continuous quality assurance process.
Safety data collected during clinical trials are incorporated into the product’s
approved label. FDA reviewers monitor products’ safety profiles. They search
for safety signals by reviewing AERS data, case reports found in medical
literature, and data from other passive and active surveillance systems. Most
of these data are coded in MedDRA®. One of the tools employed by the FDA
to identify safety signals is data mining. In-depth knowledge of MedDRA®
required for effective data mining.
Reviewers:
• Create a case definition using MedDRA® terms that describe the
clinical process of interest and create a search group containing all
possible names given to the suspect product.
• Create a case series by retrieving from AERS all cases fulfilling case
and product definitions. Add literature cases to case series.
• Evaluate raw data from individual case reports and extract all relevant
case data stratifying information as necessary.
• Provide a clinical assessment of the findings based on the nature of the
disease under treatment and adverse event characteristics.
Scientists from within FDA and from other
organizations conduct experimental and
observational studies (large populationbased databases). Use of MedDRA®
depends on the characteristics of the study
database and the existence of terminology
bridges between MedDRA® and study
database’s particular terminology (ICD,
SNOMED, etc.).
FDA provides:
• Continuous assessment of
new safety data and it’s
impact on patient safety.
• Drug safety surveillance
process guidelines.
• MedDRA® terminology
improvement
recommendations.
At each participating hospital emergency room, Center for Disease Control and Prevention (CDC)/Consumer Product Safety
Commission (CPSC) trained coders review all patient records in search for adverse drug events. Data on relevant cases,
including codes for injuries and mechanisms of injury, are entered into a standardized database and subsequently
processed by a contractor who codes this information using MedDRA® (MMWR, April 22, 2005 / 54(15);380-383; Ann
Emerg Med. 2005;45:197-206).
Currently undergoing further development and evaluation to determine
extent of use as a tool in drug safety surveillance.
Currently undergoing further development and evaluation to
determine extent of use as a tool in drug safety surveillance.
Currently undergoing further
development and evaluation to
determine extent of use as a tool in drug
safety surveillance.
Currently undergoing
further development and
evaluation to determine
extent of use as a tool in
drug safety surveillance.
Coding guidelines developed based on MedDRA® Term Selection: Points to Consider document and VA’s specific objectives.
The goal is to capture in MedDRA® terms adverse event data as close to the reporter’s verbatim as possible.
In process of developing standardized methods to process and evaluate
aggregate safety data .
In process of developing standardized methods to process and
evaluate aggregate safety data .
MedDRA® coding is applied to the stated Indications for Treatment, Medical History, Adverse Events, and Laboratory
results not represented by the Diagnosis and Medical History.
Additional MedDRA® encoded data facilitates search for potential safety
signals and their interpretation.
In process of developing standardized
methods to evaluate aggregate safety
data .
In process of developing
standardized methods to
evaluate aggregate
safety data .
* MedDRA version 8.0
** A Center for Disease Control and Prevention (CDC), Consumer Product Safety Commission (CPSC), and Food and Drug Administration (FDA) joint project