embase adverse event monitoring
TRANSCRIPT
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Adverse Event Monitoring
using Embase
New ways to identify relationships
between drugs and associated
events
Dr. Ivan Krstić Product Development Manager Embase
September 23, 2015
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Webinar control panel:
• ‘Ask a question’ for
questions and comments
• Option for full screen view
• Q&A at the end
Need to know
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How Does Information in Literature Support Drug Safety?
• Identify/monitor adverse drug reactions
• Monitor and anticipate safety risks = better risk management
• Detect rare signals — identify possible new, undiscovered or
un(der)investigated adverse drug reactions
Articles are indexed for drug, disease, medical device and essential life
science concepts
Terms such as 'adverse drug reaction' and 'drug therapy', when indexed
with a drug term, give a precise idea of what the article covers
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Agenda
How to get Drug Profiles in Embase
• adverse drug reaction (safety profiles)
• drug-drug combination
• drug-drug comparison
• drug-drug interaction
• drug therapy
How to create a Pharmacovigilance search
using Emtree, mapping and subheadings
Indexing in
Embase
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Pharmacovigilance is defined as the science and activities concerned
with the
• detection (Embase),
• assessment,
• understanding and
• prevention of adverse reactions to medicines (i.e. adverse drug
reactions or ADRs).
The ultimate goal of Pharmacovigilance is to improve the safe and
rational use of medicines, thereby
• improving patient care and
• improving public health.
Pharmacovigilance
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EMA PV guideline recommends that
the marketing authorization holders:
• are expected to monitor international scientific and medical literature in
order to detect new safety signals or emerging safety issues reported for
medicinal products through a systematic literature review of widely used
reference databases (e.g. Medline, Embase) no less frequently than once a
week.
• Reports of suspected adverse reactions from the scientific and medical
literature, including relevant published abstracts from meetings and draft
manuscripts, should be reviewed and assessed by marketing authorisation
holders to identify and record ICSRs originating from spontaneous reports or
non-interventional post-authorisation studies.
Pharmacovigilance
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Embase is the most comprehensive biomedical database and it currently
covers 8,600 journals
We cover in-press articles from 2,200 journals and
conference proceedings from 5,600 conferences (since 2009)
Embase for Medical Literature Monitoring
Embase provides:
one stop source for PV searches,
compliance with EMA PV guideline for literature monitoring
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Indexing for Embase is a manual process performed by trained
indexers with a biomedical background
Indexing principles
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Indexers read and analyze the full text
of articles in order to identify relevant
concepts, and index them with the
most specific Emtree terms
Indexing principles
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Index terms are controlled by the
Emtree thesaurus,
resulting in
consistent coverage of concepts
that may be expressed in many
different ways in the literature.
Indexing controlled by Emtree
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Embase indexing
‘furadantine‘
136 results
‘furadantin’
614 results
‘ivadantin’
3 results
Article 1 Article 2 Article 3 Article 2
furadantine ivadantin
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Embase indexing – Emtree search
Query Results
'nitrofurantoin'/de 13,395
'furadantin'/de 13,395
'ivadantin'/de 13,395
Indexing facilitates consistent and comprehensive retrieval of information
from Embase, significantly enhancing search options – power of mapping.
Emtree
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How to Get Drug Profiles in Embase
Embase contains information on:
• adverse drug reaction
• drug combination
• drug comparison
• drug interaction
• drug therapy
that is easily accessible and searchable.
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Subheadings
Subheadings are Emtree terms that are also used as concept
qualifiers for drugs, diseases and devices, providing a very precise
idea of what an article covers.
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Subheadings
Term Key Subheading
drug 'adverse drug reaction'
drug 'drug combination'
drug 'drug comparison'
drug 'drug interaction'
drug 'drug therapy'
device 'adverse device effect'
device 'device comparison'
disease 'drug therapy'
disease 'side effect'
Subheadings = concept qualifiers for drugs (17), diseases (14) and
devices (4)
Nine subheadings are denoted as key subheadings.
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Triple linking
Term Key Subheading Linked term Triple indexing example
drug 'adverse drug reaction' 'disease' 'vioxx'/'adverse drug reaction'/'hypertension'
drug 'drug combination' 'drug' 'vioxx'/'drug combination'/'ibuprofen'
drug 'drug comparison' 'drug' 'vioxx'/'drug comparison'/'naproxen'
drug 'drug interaction' 'drug' 'vioxx'/'drug interaction'/'calcitriol'
drug 'drug therapy' 'disease' 'vioxx'/'drug therapy'/'osteoarthritis'
device 'adverse device effect' 'disease' 'stent'/'adverse device effect'/'stenosis'
device 'device comparison' 'device' 'stent'/'device comparison'/'balloon'
disease 'drug therapy' 'drug' 'osteoarthritis'/'drug therapy'/‘vioxx'
disease 'side effect' 'drug' 'hypertension'/'side effect'/‘vioxx'
Since 2007, key subheadings have included triple linking — three
level indexing — which includes information on a term, key
subheading and linked term.
Triple indexing has started in 2007 for the drug triples (drug therapy
from 2009). Devices began in 2014.
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How is the Information in Triple Links Shown?
Triple links — relationships between drugs, diseases or devices and
their associated events — can be seen in individual results and can be
used to search or get an overview of all linked terms (for example all
adverse events) reported for a specific drug (since July 2015)
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Triple linking Information
For each drug, device and
disease key subheadings
and linked terms can be
visualized and filtered
1. New filter options
2. New search query language
• 'vioxx'/'adverse drug reaction'/'hypertension','stroke','nausea','vomiting'
• 'vioxx'/dd_ae/'hypertension','stroke''nausea','vomiting'
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How to use New Filter Options
1. Expand a filter. Note the new Details option
Drugs, Diseases and Device results filters are labelled Beta to signify that this
will be assessed as a Beta feature for 6-9 months. It is hyperlinked to help.
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How to use New Filter Options
2. Note the Key subheadings information that appears
• Check the box beside a key subheading to select all (e.g.) adverse
drug reactions for a drug
• Click on a key subheading text to display specific linked terms
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How to use New Filter Options
3. Check the box beside or click on linked term(s) to select them
When one or more linked terms are selected the key subheading (e.g.
adverse drug reaction) gets semi-checked and ‘Details’ button gets
highlighted
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Users can select multiple linked-terms (adverse drug reactions) for one key
subheading.
Application interprets this as:
'rofecoxib'/'adverse drug reaction'/'hypertension','stroke','thrombosis'
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Application interprets that as combination of two searches connected with OR
operator:
'rofecoxib'/'adverse drug reaction'/'hypertension','stroke' OR 'rofecoxib'/'drug
therapy'/'colorectal cancer','osteoarthritis'
Users can select multiple key subheading and multiple linked-terms (adverse
drug reactions, therapies) for one drug.
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Application interprets this as combination of multiple searches connected with
OR operator:
'rofecoxib'/'adverse drug reaction'/'hypertension','stroke' OR 'naproxen'/'adverse
drug reaction'/'heart infarction','hepatitis'
Users can select multiple drugs and multiple key subheading and multiple
linked-terms (adverse drug reactions, therapies).
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Apply Multiple Filters at Once
• All selected filter options
will be applied when
is clicked
• indicates all linked terms
are selected
• indicates one or more
linked terms are selected
• Linked terms can be
exported to identify (e.g.)
all ADRs for a specific drug
• Multiple options within a
filter cluster are searched
using ‘OR’. Between
different filters clusters,
‘AND’ is applied
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Linked terms are
displayed and
sortable by
# records:
descending and
ascending.
Allows to:
Detect rare signals —
identify possible new,
undiscovered or
un(der)investigated
adverse drug reactions
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Drug Profiles
Drug details can be exported provided
the information on:
• adverse drug reaction
• drug combination
• drug comparison
• drug interaction
• drug therapy
Such drug profiles can be easily
filtered by publication year.
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New Search Query Language
With a single search string, users will be able to specify multiple search
parameters:
• Drug term (or device or disease)
• Key Subheading(s) (e.g., adverse drug reaction, drug therapy)
• Linked terms (e.g., hypertension, stroke, nausea, vomiting, etc.)
Multiple subheadings or multiple linked terms can be listed in a single
search string separated by a comma (no space after the comma).
e.g. 'vioxx'/’adverse drug reaction’/'hypertension','stroke''nausea','vomiting'
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New Search Query Language
Newly-introduced search syntax (e.g., ‘adverse drug reaction’) can be
used, in addition to the existing query codes (e.g., dd_ae).
• Autocomplete enables users to quickly identify the correct search
syntax to use.
• The same principal works for drugs, diseases and devices
Some examples:
• Drug/Subheading/Linked term(s). 'vioxx'/'adverse drug reaction'/'hypertension','stroke','nausea','vomiting'
• Drug/Subheading (as code)/Linked term(s). 'vioxx'/dd_ae/'hypertension','stroke''nausea','vomiting'
• Drug/Multiple subheadings. 'vioxx'/'adverse drug reaction','drug therapy'
More info: http://help.elsevier.com/app/answers/detail/a_id/6197/p/9754/c/9863,10681
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Drug subheadings
'ivadantin'/de/'drug toxicity','adverse drug reaction'
Pharmacovigilance search using Emtree (mapping & subheadings)
mapping
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Drug subheadings and generic terms for adverse effects
'ivadantin'/de/'drug toxicity','adverse drug reaction‘ OR
(‘ivadantin'/de AND ('adverse drug reaction'/exp OR 'side effect'/exp OR 'drug
safety'/exp OR 'drug toxicity'/exp OR safety OR complication* OR toxicity OR adrs
OR (adverse OR side OR undesirable) NEXT/2 (effect* OR reaction* OR event* OR
outcome*) OR 'toxicity and intoxication'/exp OR 'fertility'/exp OR 'toxicology'/exp OR
'toxicity testing'/exp OR 'carcinogenesis'/exp OR toxicity OR 'drug
carcinogenicity'/exp OR carcinogenicit* OR 'drug hypersensitivity'/exp OR
hypersensitivit* OR 'mutagenicity'/exp OR 'morbidity'/exp OR 'mortality'/exp))
Pharmacovigilance search using Emtree
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'ivadantin'/'drug toxicity','adverse drug reaction' OR
(‘ivadantin'/de AND ('adverse drug reaction'/exp OR 'side effect'/exp OR 'drug safety'/exp OR 'drug
toxicity'/exp OR safety OR complication* OR toxicity OR adrs OR (adverse OR side OR undesirable)
NEXT/2 (effect* OR reaction* OR event* OR outcome*) OR 'toxicity and intoxication'/exp OR 'fertility'/exp
OR 'toxicology'/exp OR 'toxicity testing'/exp OR 'carcinogenesis'/exp OR 'drug carcinogenicity'/exp OR
carcinogenicit* OR 'drug hypersensitivity'/exp OR hypersensitivit* OR 'mutagenicity'/exp OR 'morbidity'/exp
OR 'mortality'/exp OR
'reproduction'/exp OR 'reproduction' OR 'pregnancy disorder'/exp OR 'lactation'/exp OR 'lactation' OR
'pregnancy disorders of endocrine origin'/exp OR 'breast feeding'/exp OR 'breast milk'/exp OR 'breast'
NEXT/2 ('feeding' OR 'milk') OR 'prenatal disorder'/exp OR 'embryonic and fetal functions'/exp OR
'parameters concerning the fetus, newborn and pregnancy'/exp OR 'pregnancy'/exp OR 'pregnancy' OR
'teratology'/exp OR 'prenatal drug exposure'/exp OR 'prenatal exposure'/exp OR 'prenatal' OR embryo* OR
'newborn' OR 'fetus' OR 'perinatal' OR 'perinatal drug exposure'/exp OR 'maternal exposure'/exp OR
'maternal exposure' OR 'elderly'/exp OR 'elderly' OR 'aged' OR 'addiction'/exp OR 'addiction' OR 'drug
withdrawal'/exp OR 'drug withdrawal' OR 'treatment failure'/exp OR 'drug treatment failure'/exp OR
'treatment failure' OR 'drug resistance'/exp OR 'drug resistance' OR 'drug tolerance'/exp OR 'drug tolerance'
OR 'drug induced' OR 'drug induced disease'/exp OR 'drug abuse'/exp OR 'substance abuse'/exp OR 'drug
misuse'/exp OR 'drug overdose'/exp OR abuse OR misuse OR overdose OR 'medication error'/exp OR
'medication error' OR 'off label drug use'/exp OR 'occupational exposure'/exp OR 'occupational exposure'
OR 'overdose' OR 'off label use' OR 'off label drug use' OR 'drug efficacy'/exp OR 'drug efficacy' OR
'death'/exp OR 'death' OR 'drug interaction'/exp OR 'drug interaction' OR 'intoxication' OR 'drug
contraindication'/exp OR 'drug contraindication' OR 'congenital disorder'/exp OR 'congenital disorder' OR
'case report'/exp OR 'case report' OR 'treatment contraindication'/exp OR 'treatment contraindication'))
Drug subheadings and generic adverse effects terms and special situations
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Set up an Alert
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Where to Find more Information
Help file (support hub):
• News item for July 31st release
• What are triple links (triple indexing)?
• How do I apply filters to identify drug, disease and device
information found in Triple Links?
• How do I write search queries to identify drug, disease and device
information found in 'Triple Links'?
• What are subheadings in Embase?
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Thank you!
• Q&A will be sent to you by email. For more information and
questions please contact your regional office
• Our next Embase webinar is on October 28th and will focus on
Embase indexing.
• Please fill out the survey that appears on your screen after leaving
the webinar.
Any questions?