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1
Embase for
Pharmacovigilance
Search Strategy Creation
and Validation
Ivan Krstić, PhD
Senior Product Development Manager Embase
March 22th 2017
2
Agenda
In this webinar, we will discuss:
• Literature Screening for Pharmacovigilance – Intro
• Tips and Tricks – Embase Search Syntax
• How to Build a Search Strategy on Embase for PV Based on Industry Best
Practices
• Demo – PV Wizard on embase.com
‫‫‬Ensuring
regulatory
compliance
3
Pharmacovigilance
Pharmacovigilance is defined as the
science and activities concerned with:
• detection (Embase),
• assessment (Quosa PV),
• understanding and
• prevention
of adverse reactions to medicines.
The ultimate goal of Pharmacovigilance
is to improve the safe and rational use
of medicines, thereby:
• improving patient care and
• improving public health.
4
Regulatory Mandate for Literature Screening
• EMA’s‫‫‬Good‫‫‬Vigilance‫‫‬Practice‫(‫‬GVP)‫‫‬Module VI
• Code of Federal Regulations, Title 21, parts 314.80.b
• Code of Federal Regulations, Title 21, parts 600.80.b
5
EMA requirements (GVP Module VI)
In addition, marketing authorisation holders should have procedures in place to monitor scientific
and medical publications in local journals in countries where medicinal products have a marketing
authorisation, and to bring them to the attention of the company safety department as appropriate.
VI.B.1.1.2. Literature reports
The scientific and medical literature is a significant source of information for the monitoring of the
safety profile and of the risk benefit balance of medicinal products, particularly in relation to the
detection of new safety signals or emerging safety issues. Marketing authorization holders are
therefore expected to maintain awareness of possible publications through a systematic literature
review of widely used reference databases (e.g. Medline, Excerpta Medica or 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.
Local literature project in pipeline. Interested?
Contact as at: embase@elsevier.com
6
Regulatory Compliance
Why Embase?
− Comprehensive (8,600
journals, also AiP)
− Current (6,000 records/day)
− Deep indexing
− ADR subheadings
− Search for classes of drugs/
devices
− Weekly alerts
− Automate content delivery –
API
− Lit. monitoring solution with
QUOSA (PV)
− Includes grey literature
(conference abstracts)
− 2,800 more journals than
MEDLINE
− Recommended and used by
EMA
Without Embase, critical ADR’s might be
missed, risking:
• Possible fines due to non-compliance
• Damage to company reputation
• Likelihood‫‫‬of‫‫‬review‫‫‬by‫‫‬gov’t‫‫‬body
Leukemia Drug Pulled from Sale by FDA
7
Search Strategy for Literature
Monitoring
8
Importance of Search Strategy in Literature Monitoring
Some consider that search strategy creation and maintenance should be
handled as a GxP activity, needing Verification and Validation, as any other
GxP process.
Search strategy
(weekly alerts
on Embase)
Literature
Screening
process
MAH’s‫‫‬Safety‫‫‬
Database
EudraVigilance
and FAERS
Although there is no specific regulatory mandate, the Literature Monitoring
process can be (and in fact is) inspected and audited.
It is a field in which a QPPV must be ready to answer questions, and it must be
described in the Pharmacovigilance System Master File (PSMF).
9
Search Strategy for Literature Monitoring
Validation of a search strategy consists of documenting evidence that a
specific search strategy consistently produces a set of records meeting its
pre-defined quality attributes.
Information science defines Precision and Recall as the two quality attributes
of a search strategy.
Precision: How many of the records in the result set are relevant to our need
Recall: From all records that are relevant to our need, how many are present in
the search result
10
Precision and Recall
Precision and Recall are a balancing
act. One has, usually, to sacrifice high
Precision (let irrelevant records in) in
order to get high Recall (not miss any
relevant records).
Precision impacts productivity: Low values mean too much noise (irrelevant
records) is coming in, but it can’t be increased at the cost of Recall.
Ideally the goal is to build a search strategy with a recall close to 100% and as
high as possible precision.
Recall is the quality measurement of a literature monitoring search strategy.
11
Prerequisite
Presence of a GOLD data set from all known relevant articles for a limited
time frame (no less than 150 articles)
e.g.: 2014-2017
MAH’s‫‫‬Safety‫‫‬Database
GOLD set
12
How to build search strategy – general tips
• Leverage in-depth indexing of drugs on Embase and use Emtree terms
and subheadings.
• Text searching of the title, abstract required, as a supplementary measure.
• Great understanding of all the fields (meta data) available in the database
(e.g.: tradenames)
• Good knowledge of the search syntax is required, e.g: Boolean and
proximity operators, wildcards.
• Good understanding of the medicinal product properties and known
interactions may also help.
13
Reminder: subheadings
Subheadings are Emtree
terms that are also used as
concept qualifiers for
drugs to provide additional
information about context.
14
Reminder: Search syntax
Truncation / Wildcards
*
(replaces one or more letters)
sul*ur retrieves sulfur, sulphur
'heart attack*' retrieves heart attack, heart attacks
?
(single-letter truncation)
sulf?nyl
retrieves records that contain words like
'sulfonyl' and 'sulfinyl'
catheter?
retrieves records that contain words like
'catheters', but not 'catheter' or 'catheterization'
Proximity operators
NEAR/n drug* NEAR/2 adverse
The words must be within n words inclusive of
each other in the record
NEXT/n adverse NEXT/2 reaction*
The words must be within n words inclusive of
each other in the same order as they appear in
the search form
15
Reminder: Search syntax
Field codes
:ab,ti
(in abstract or titles)
'heart attack':ab,ti
This option retrieves records where the phrase
'heart attack' is found in the title or abstract.
:de
(Emtree term)
'heart attack‘:de
This option maps your search terms to the
Emtree preferred indexing term.
/exp
(term explosion)
'heart attack'/exp
This option maps your search terms to the
Emtree preferred indexing term and then
searches for the related narrower (children)
terms.
/lnk
(subheading)
'side effect'/lnk
Subheadings are concept qualifiers for drugs,
diseases or devices used to refine context.
16
GVP Module VI
VI.B.1. Collection of reports
Competent authorities and marketing authorisation holders should take appropriate
measures in order to collect and collate all reports of suspected adverse reactions
associated with medicinal products for human use originating from unsolicited or
solicited sources.
VI.B.6. Special situations
VI.B.6.1. Use of a medicinal product during pregnancy or breastfeeding
VI.B.6.2. Use of a medicinal product in a paediatric or elderly population
VI.B.6.3. Reports of overdose, abuse, off-label use, misuse, medication error or
occupational exposure
VI.B.6.4. Lack of therapeutic efficacy
17
Building Search Strategy
(Based on Industry Best Practices)
18
'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction'
OR ('paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4
acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti…
AND ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR
adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2
(effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side
effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp
OR complication*:de,ab,ti OR 'case report*':de,ab,ti …
OR 'pregnancy'/exp OR pregnant*:de,ab,ti OR pregnanc*:de,ab,ti OR
'pregnancy complication'/exp OR 'pregnancy disorder'/exp OR
'abortion'/exp OR 'abortion':de,ab,ti OR…))
AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR
girl)
Drug
subheadings
Drug name
and variants
Adverse drug
reaction concept
Special
situations
Human limit
PV Search Strategy – full
Recall 100%
19
PV Search Strategy
– part 1
[drug subheadings]
[drug]/[subheadings] 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction'
20
[drug names]
PV Search Strategy
– part 2
[drug subheadings]
[drug]/[subheadings] OR
[drug names]
'paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4
acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4` hydroxyacetanilide':tn,ab,ti
OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli forte suppositories for kids':tn,ab,ti OR
'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR 'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR
'acetamino phenol':tn,ab,ti OR 'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR
'acetaminophenol':tn,ab,ti OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR
'acetylaminophenol':tn,ab,ti OR 'adorem':tn,ab,ti OR 'afebrin':tn,ab,ti OR 'algiafin':tn,ab,ti OR
'algotropyl':tn,ab,ti OR 'alphagesic':tn,ab,ti OR 'alvedon':tn,ab,ti OR 'amadil':tn,ab,ti OR 'anacin
3':tn,ab,ti OR 'anaflon':tn,ab,ti…
21
[drug names]
PV Search Strategy
– part 3 [adverse drug reaction]
11.7M
[drug subheadings]
[drug]/[subheadings] OR
([drug names] AND [adverse drug reaction])
22
[drug names]
PV Search Strategy
– part 4 [adverse drug reaction]
11.7M
[special conditions]
6.8M
[drug subheadings]
[drug]/[subheadings] OR
([drug names] AND ([adverse drug reaction] OR [special conditions]))
23
[drug names]
PV Search Strategy
– part 5 [adverse drug reaction]
11.7M
[special conditions]
6.8M
[human limit]
19.9M
[drug subheadings]
[drug]/[subheadings] OR
([drug names] AND
([adverse drug reaction] OR [special conditions]))
AND [human limit]
24
[drug names]
PV Search Strategy
– results [adverse drug reaction]
11.7M
[special conditions]
6.8M
[human limit]
19.9M
[drug subheadings]
[drug]/[subheadings] OR
([drug names] AND
([adverse drug reaction] OR [special conditions]))
AND [human limit]
25
Drug subheadings
'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction'
PV Search Strategy – Part 1: Subheadings
26
Drug name and variants
'paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti
OR '4 acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4`
hydroxyacetanilide':tn,ab,ti OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli
forte suppositories for kids':tn,ab,ti OR 'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR
'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR 'acetamino phenol':tn,ab,ti OR
'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR 'acetaminophenol':tn,ab,ti
OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR 'acetylaminophenol':tn,ab,ti
OR 'adorem':tn,ab,ti OR 'afebrin':tn,ab,ti OR …
PV Search Strategy – Part 2: Drug Names
Field codes:
:de – index term
:tn – tradename
:ti – title
:ab – abstract
27
'paracetamol-induced':ab,ti OR ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk
OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction*
OR event* OR outcome*)):de,ab,ti OR 'side effect'/lnk OR 'side effect'/exp OR
'complication'/lnk OR 'complication'/exp OR complication*:de,ab,ti OR 'worsening':de,ab,ti
OR 'case report*':de,ab,ti OR 'pharmacovigilance':de,ab,ti OR 'postmarketing surveillance'/exp
OR 'drug interaction':lnk OR 'drug interaction'/exp OR 'toxicity'/exp OR 'drug toxicity':lnk OR
toxic*:de,ab,ti OR intox*:de,ab,ti OR 'safety':de,ab,ti OR poison*:de,ab,ti OR
pharmacotox*:de,ab,ti OR neurotox*:de,ab,ti OR cardiotox*:de,ab,ti OR nephrotox*:de,ab,ti
OR hepatotox*:de,ab,ti OR immunotox*:de,ab,ti OR immunocytotox*:de,ab,ti OR
cytotox*:de,ab,ti OR carcinogen*:de,ab,ti OR cancerogen*:de,ab,ti OR mutagen*:de,ab,ti OR
terato*:de,ab,ti OR 'fatal outcome'/exp OR 'death'/exp OR death*:de,ab,ti OR 'suicide'/exp OR
suicid*:de,ab,ti OR mortal*:de,ab,ti OR fatal*:de,ab,ti OR 'risk'/exp OR nocebo:de,ab,ti OR
'lethal concentration'/exp OR 'iatrogenic disease'/exp OR 'fertility'/exp OR 'substance-related
disorders'/exp OR 'chemically induced':de,ab,ti OR 'morbidity':de,ab,ti OR 'congenital
disorder':de,ab,ti OR infertility/exp OR injury/exp)
PV Search Strategy – Part 3: Adverse Drug Reactions
28
'pregnancy'/exp OR pregnant*:de,ab,ti OR pregnanc*:de,ab,ti OR 'pregnancy complication'/exp OR
'pregnancy disorder'/exp OR 'abortion'/exp OR 'abortion':de,ab,ti OR 'lactation'/exp OR 'breast
feeding':de,ab,ti OR 'breastfeeding':de,ab,ti OR 'breast milk':de,ab,ti OR 'reproduction'/de OR 'fetus'/de OR
'embryo'/de OR 'prenatal':de,ab,ti OR 'perinatal':de,ab,ti OR 'newborn':de,ab,ti OR‫‘‫‬parameters‫‫‬concerning‫‫‬
the‫‫‬fetus,‫‫‬newborn‫‫‬and‫‫‬pregnancy’/exp OR aged/exp OR elderly:de,ti,ab OR geriatric*:ti,ab OR
((environmental OR occupational) NEXT/1 exposure*):de,ab,ti OR 'compassionate use':de,ab,ti OR (named
NEXT/1 (use OR patient*)):ab,ti OR 'inappropriate prescri*':de,ab,ti OR 'drug metabolism'/exp OR 'organ
dysfunction':de,ab,ti OR 'organ failure':de,ab,ti OR 'hypersensitivit*':de,ab,ti OR allerg*:de,ab,ti OR
counterfeit:de,ab,ti OR 'falsified drug':de,ab,ti OR ('unavailab*' NEAR/2 drug):de,ab,ti OR 'drug
resistance'/exp OR 'drug resistance':de,ab,ti OR 'withdrawal syndrome'/de OR (drug* NEAR/3 (withdrawal
OR toleran* OR interact* OR exposure* OR induc* OR resist* OR ineff* OR nonrespon* OR
unrespon*)):de,ab,ti OR 'drug tolerance'/exp OR ((drug* OR treatment) NEXT/1 (failure* OR
contraindication*)):de,ab,ti OR 'medication error'/exp OR (near NEXT/1 miss*):ab,ti OR ineff*:ti OR
nonrespon*:ti OR unrespon*:ti OR ((lack OR no OR non OR 'not') NEXT/2 (eff* OR respon*)):ab,ti OR
'device failure':de,ab,ti OR manufacturing near/3 (error or fault or mistake or failure or contamination or
impurity)‫‫‬OR‫‘‫‬patient‫‫‬compliance’/exp OR overdos*:de,ab,ti OR 'drug abuse'/exp OR abus*:de,ab,ti OR
misus*:de,ab,ti OR 'off label':de,ab,ti OR unlicensed:de,ab,ti
PV Search Strategy – part 4: Special Situations
29
PV Search Strategy – Part 5: Human Limit*
…AND
('human'/exp OR human OR m?n OR wom?n OR child OR boy OR girl)
*‫‫‬for‫‫‬ICSR’s
30
'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction'
OR 'paracetamol-induced':de,ab,ti
OR ('paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4
acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti…
AND ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR
adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2
(effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side
effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp
OR complication*:de,ab,ti OR 'case report*':de,ab,ti …
OR 'drug resistance'/exp OR 'drug resistance':de,ab,ti OR 'withdrawal
syndrome'/de OR (drug* NEAR/3 (withdrawal OR toleran* OR interact*
OR exposure* OR induc* OR resist* OR ineff* OR nonrespon* OR
unrespon*)):de,ab,ti…))
AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR
girl)
Subheadings
Drug name
and variants
Adverse drug
reactions
Special
situations
Human limit
PV Search Strategy – full
31
Review Search Terms to Increase Precision
intoxic*:de,ti,ab
Products
# of records
without
Additional Citations Screened Citations Relevant Citations
Product 1 11 0 0 0
Product 2 6325 58 58 6
Product 3 13 0 0 0
Product 4 78 2 2 0
Product 5 143 3 3 0
Product 6 4243 9 9 0
Product 7 177 0 0 0
Product 8 18343 317 100 1
Product 9 29 0 0 0
Product 10 764 5 5 0
Total 30126 394 177 7
period of 3 years
Please make sure all is documented!
32
Set up an Email Alert
33
Email Alert history can be exported
34
Email Alert history is auditable
35
Demo
Please contact us at if you are interested in testing the PV wizard?
embase@elsevier.com
36
Regular Reviews of the PV Search Strategy
• Emtree updates three times per year
• New search artefacts can be introduced
• New indexing policies can be enforced
• Always perform the review maintaining documented evidence that
a specific search strategy consistently produces a record set
meeting its pre-determined quality attributes
Thank you!
Any questions?
Ivan Krstić, PhD
Senior Product Development Manager Embase
i.krstic@elsevier.com
38
PV Wizard
39
1/5
40
2/5
41
3/5
42
4/5
43
5/5
44
Once a search is run from saved search space it gets displayed on results page as
any other regular search.
Import EMA’s‫‫‬MLM‫‫‬search

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Embase for pharmacovigilance: Search and validation March 22 2017

  • 1. 1 Embase for Pharmacovigilance Search Strategy Creation and Validation Ivan Krstić, PhD Senior Product Development Manager Embase March 22th 2017
  • 2. 2 Agenda In this webinar, we will discuss: • Literature Screening for Pharmacovigilance – Intro • Tips and Tricks – Embase Search Syntax • How to Build a Search Strategy on Embase for PV Based on Industry Best Practices • Demo – PV Wizard on embase.com ‫‫‬Ensuring regulatory compliance
  • 3. 3 Pharmacovigilance Pharmacovigilance is defined as the science and activities concerned with: • detection (Embase), • assessment (Quosa PV), • understanding and • prevention of adverse reactions to medicines. The ultimate goal of Pharmacovigilance is to improve the safe and rational use of medicines, thereby: • improving patient care and • improving public health.
  • 4. 4 Regulatory Mandate for Literature Screening • EMA’s‫‫‬Good‫‫‬Vigilance‫‫‬Practice‫(‫‬GVP)‫‫‬Module VI • Code of Federal Regulations, Title 21, parts 314.80.b • Code of Federal Regulations, Title 21, parts 600.80.b
  • 5. 5 EMA requirements (GVP Module VI) In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate. VI.B.1.1.2. Literature reports The scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or 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. Local literature project in pipeline. Interested? Contact as at: embase@elsevier.com
  • 6. 6 Regulatory Compliance Why Embase? − Comprehensive (8,600 journals, also AiP) − Current (6,000 records/day) − Deep indexing − ADR subheadings − Search for classes of drugs/ devices − Weekly alerts − Automate content delivery – API − Lit. monitoring solution with QUOSA (PV) − Includes grey literature (conference abstracts) − 2,800 more journals than MEDLINE − Recommended and used by EMA Without Embase, critical ADR’s might be missed, risking: • Possible fines due to non-compliance • Damage to company reputation • Likelihood‫‫‬of‫‫‬review‫‫‬by‫‫‬gov’t‫‫‬body Leukemia Drug Pulled from Sale by FDA
  • 7. 7 Search Strategy for Literature Monitoring
  • 8. 8 Importance of Search Strategy in Literature Monitoring Some consider that search strategy creation and maintenance should be handled as a GxP activity, needing Verification and Validation, as any other GxP process. Search strategy (weekly alerts on Embase) Literature Screening process MAH’s‫‫‬Safety‫‫‬ Database EudraVigilance and FAERS Although there is no specific regulatory mandate, the Literature Monitoring process can be (and in fact is) inspected and audited. It is a field in which a QPPV must be ready to answer questions, and it must be described in the Pharmacovigilance System Master File (PSMF).
  • 9. 9 Search Strategy for Literature Monitoring Validation of a search strategy consists of documenting evidence that a specific search strategy consistently produces a set of records meeting its pre-defined quality attributes. Information science defines Precision and Recall as the two quality attributes of a search strategy. Precision: How many of the records in the result set are relevant to our need Recall: From all records that are relevant to our need, how many are present in the search result
  • 10. 10 Precision and Recall Precision and Recall are a balancing act. One has, usually, to sacrifice high Precision (let irrelevant records in) in order to get high Recall (not miss any relevant records). Precision impacts productivity: Low values mean too much noise (irrelevant records) is coming in, but it can’t be increased at the cost of Recall. Ideally the goal is to build a search strategy with a recall close to 100% and as high as possible precision. Recall is the quality measurement of a literature monitoring search strategy.
  • 11. 11 Prerequisite Presence of a GOLD data set from all known relevant articles for a limited time frame (no less than 150 articles) e.g.: 2014-2017 MAH’s‫‫‬Safety‫‫‬Database GOLD set
  • 12. 12 How to build search strategy – general tips • Leverage in-depth indexing of drugs on Embase and use Emtree terms and subheadings. • Text searching of the title, abstract required, as a supplementary measure. • Great understanding of all the fields (meta data) available in the database (e.g.: tradenames) • Good knowledge of the search syntax is required, e.g: Boolean and proximity operators, wildcards. • Good understanding of the medicinal product properties and known interactions may also help.
  • 13. 13 Reminder: subheadings Subheadings are Emtree terms that are also used as concept qualifiers for drugs to provide additional information about context.
  • 14. 14 Reminder: Search syntax Truncation / Wildcards * (replaces one or more letters) sul*ur retrieves sulfur, sulphur 'heart attack*' retrieves heart attack, heart attacks ? (single-letter truncation) sulf?nyl retrieves records that contain words like 'sulfonyl' and 'sulfinyl' catheter? retrieves records that contain words like 'catheters', but not 'catheter' or 'catheterization' Proximity operators NEAR/n drug* NEAR/2 adverse The words must be within n words inclusive of each other in the record NEXT/n adverse NEXT/2 reaction* The words must be within n words inclusive of each other in the same order as they appear in the search form
  • 15. 15 Reminder: Search syntax Field codes :ab,ti (in abstract or titles) 'heart attack':ab,ti This option retrieves records where the phrase 'heart attack' is found in the title or abstract. :de (Emtree term) 'heart attack‘:de This option maps your search terms to the Emtree preferred indexing term. /exp (term explosion) 'heart attack'/exp This option maps your search terms to the Emtree preferred indexing term and then searches for the related narrower (children) terms. /lnk (subheading) 'side effect'/lnk Subheadings are concept qualifiers for drugs, diseases or devices used to refine context.
  • 16. 16 GVP Module VI VI.B.1. Collection of reports Competent authorities and marketing authorisation holders should take appropriate measures in order to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources. VI.B.6. Special situations VI.B.6.1. Use of a medicinal product during pregnancy or breastfeeding VI.B.6.2. Use of a medicinal product in a paediatric or elderly population VI.B.6.3. Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure VI.B.6.4. Lack of therapeutic efficacy
  • 17. 17 Building Search Strategy (Based on Industry Best Practices)
  • 18. 18 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction' OR ('paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti… AND ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp OR complication*:de,ab,ti OR 'case report*':de,ab,ti … OR 'pregnancy'/exp OR pregnant*:de,ab,ti OR pregnanc*:de,ab,ti OR 'pregnancy complication'/exp OR 'pregnancy disorder'/exp OR 'abortion'/exp OR 'abortion':de,ab,ti OR…)) AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR girl) Drug subheadings Drug name and variants Adverse drug reaction concept Special situations Human limit PV Search Strategy – full Recall 100%
  • 19. 19 PV Search Strategy – part 1 [drug subheadings] [drug]/[subheadings] 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction'
  • 20. 20 [drug names] PV Search Strategy – part 2 [drug subheadings] [drug]/[subheadings] OR [drug names] 'paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4` hydroxyacetanilide':tn,ab,ti OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli forte suppositories for kids':tn,ab,ti OR 'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR 'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR 'acetamino phenol':tn,ab,ti OR 'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR 'acetaminophenol':tn,ab,ti OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR 'acetylaminophenol':tn,ab,ti OR 'adorem':tn,ab,ti OR 'afebrin':tn,ab,ti OR 'algiafin':tn,ab,ti OR 'algotropyl':tn,ab,ti OR 'alphagesic':tn,ab,ti OR 'alvedon':tn,ab,ti OR 'amadil':tn,ab,ti OR 'anacin 3':tn,ab,ti OR 'anaflon':tn,ab,ti…
  • 21. 21 [drug names] PV Search Strategy – part 3 [adverse drug reaction] 11.7M [drug subheadings] [drug]/[subheadings] OR ([drug names] AND [adverse drug reaction])
  • 22. 22 [drug names] PV Search Strategy – part 4 [adverse drug reaction] 11.7M [special conditions] 6.8M [drug subheadings] [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions]))
  • 23. 23 [drug names] PV Search Strategy – part 5 [adverse drug reaction] 11.7M [special conditions] 6.8M [human limit] 19.9M [drug subheadings] [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions])) AND [human limit]
  • 24. 24 [drug names] PV Search Strategy – results [adverse drug reaction] 11.7M [special conditions] 6.8M [human limit] 19.9M [drug subheadings] [drug]/[subheadings] OR ([drug names] AND ([adverse drug reaction] OR [special conditions])) AND [human limit]
  • 25. 25 Drug subheadings 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction' PV Search Strategy – Part 1: Subheadings
  • 26. 26 Drug name and variants 'paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti OR '4 hydroxyacetanilide':tn,ab,ti OR '4` hydroxyacetanilide':tn,ab,ti OR 'abenol':tn,ab,ti OR 'acamol':tn,ab,ti OR 'acamoli forte suppositories for kids':tn,ab,ti OR 'acenol':tn,ab,ti OR 'acephen':tn,ab,ti OR 'acet suppositories':tn,ab,ti OR 'acetalgin':tn,ab,ti OR 'acetamino phenol':tn,ab,ti OR 'acetaminophen':tn,ab,ti OR 'acetaminophene':tn,ab,ti OR 'acetaminophenol':tn,ab,ti OR 'acetamol':tn,ab,ti OR 'acetomenophen':tn,ab,ti OR 'acetylaminophenol':tn,ab,ti OR 'adorem':tn,ab,ti OR 'afebrin':tn,ab,ti OR … PV Search Strategy – Part 2: Drug Names Field codes: :de – index term :tn – tradename :ti – title :ab – abstract
  • 27. 27 'paracetamol-induced':ab,ti OR ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp OR complication*:de,ab,ti OR 'worsening':de,ab,ti OR 'case report*':de,ab,ti OR 'pharmacovigilance':de,ab,ti OR 'postmarketing surveillance'/exp OR 'drug interaction':lnk OR 'drug interaction'/exp OR 'toxicity'/exp OR 'drug toxicity':lnk OR toxic*:de,ab,ti OR intox*:de,ab,ti OR 'safety':de,ab,ti OR poison*:de,ab,ti OR pharmacotox*:de,ab,ti OR neurotox*:de,ab,ti OR cardiotox*:de,ab,ti OR nephrotox*:de,ab,ti OR hepatotox*:de,ab,ti OR immunotox*:de,ab,ti OR immunocytotox*:de,ab,ti OR cytotox*:de,ab,ti OR carcinogen*:de,ab,ti OR cancerogen*:de,ab,ti OR mutagen*:de,ab,ti OR terato*:de,ab,ti OR 'fatal outcome'/exp OR 'death'/exp OR death*:de,ab,ti OR 'suicide'/exp OR suicid*:de,ab,ti OR mortal*:de,ab,ti OR fatal*:de,ab,ti OR 'risk'/exp OR nocebo:de,ab,ti OR 'lethal concentration'/exp OR 'iatrogenic disease'/exp OR 'fertility'/exp OR 'substance-related disorders'/exp OR 'chemically induced':de,ab,ti OR 'morbidity':de,ab,ti OR 'congenital disorder':de,ab,ti OR infertility/exp OR injury/exp) PV Search Strategy – Part 3: Adverse Drug Reactions
  • 28. 28 'pregnancy'/exp OR pregnant*:de,ab,ti OR pregnanc*:de,ab,ti OR 'pregnancy complication'/exp OR 'pregnancy disorder'/exp OR 'abortion'/exp OR 'abortion':de,ab,ti OR 'lactation'/exp OR 'breast feeding':de,ab,ti OR 'breastfeeding':de,ab,ti OR 'breast milk':de,ab,ti OR 'reproduction'/de OR 'fetus'/de OR 'embryo'/de OR 'prenatal':de,ab,ti OR 'perinatal':de,ab,ti OR 'newborn':de,ab,ti OR‫‘‫‬parameters‫‫‬concerning‫‫‬ the‫‫‬fetus,‫‫‬newborn‫‫‬and‫‫‬pregnancy’/exp OR aged/exp OR elderly:de,ti,ab OR geriatric*:ti,ab OR ((environmental OR occupational) NEXT/1 exposure*):de,ab,ti OR 'compassionate use':de,ab,ti OR (named NEXT/1 (use OR patient*)):ab,ti OR 'inappropriate prescri*':de,ab,ti OR 'drug metabolism'/exp OR 'organ dysfunction':de,ab,ti OR 'organ failure':de,ab,ti OR 'hypersensitivit*':de,ab,ti OR allerg*:de,ab,ti OR counterfeit:de,ab,ti OR 'falsified drug':de,ab,ti OR ('unavailab*' NEAR/2 drug):de,ab,ti OR 'drug resistance'/exp OR 'drug resistance':de,ab,ti OR 'withdrawal syndrome'/de OR (drug* NEAR/3 (withdrawal OR toleran* OR interact* OR exposure* OR induc* OR resist* OR ineff* OR nonrespon* OR unrespon*)):de,ab,ti OR 'drug tolerance'/exp OR ((drug* OR treatment) NEXT/1 (failure* OR contraindication*)):de,ab,ti OR 'medication error'/exp OR (near NEXT/1 miss*):ab,ti OR ineff*:ti OR nonrespon*:ti OR unrespon*:ti OR ((lack OR no OR non OR 'not') NEXT/2 (eff* OR respon*)):ab,ti OR 'device failure':de,ab,ti OR manufacturing near/3 (error or fault or mistake or failure or contamination or impurity)‫‫‬OR‫‘‫‬patient‫‫‬compliance’/exp OR overdos*:de,ab,ti OR 'drug abuse'/exp OR abus*:de,ab,ti OR misus*:de,ab,ti OR 'off label':de,ab,ti OR unlicensed:de,ab,ti PV Search Strategy – part 4: Special Situations
  • 29. 29 PV Search Strategy – Part 5: Human Limit* …AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR girl) *‫‫‬for‫‫‬ICSR’s
  • 30. 30 'paracetamol'/'drug toxicity','drug interaction','adverse drug reaction' OR 'paracetamol-induced':de,ab,ti OR ('paracetamol':de OR '4 acetamidophenol':tn,ab,ti OR '4 acetaminophenol':tn,ab,ti OR '4 acetylaminophenol':tn,ab,ti… AND ('adverse drug reaction'/exp OR 'adverse drug reaction':lnk OR adverse:de,ab,ti OR ((side OR undesirable OR unwanted) NEXT/2 (effect* OR reaction* OR event* OR outcome*)):de,ab,ti OR 'side effect'/lnk OR 'side effect'/exp OR 'complication'/lnk OR 'complication'/exp OR complication*:de,ab,ti OR 'case report*':de,ab,ti … OR 'drug resistance'/exp OR 'drug resistance':de,ab,ti OR 'withdrawal syndrome'/de OR (drug* NEAR/3 (withdrawal OR toleran* OR interact* OR exposure* OR induc* OR resist* OR ineff* OR nonrespon* OR unrespon*)):de,ab,ti…)) AND ('human'/exp OR human OR m?n OR wom?n OR child OR boy OR girl) Subheadings Drug name and variants Adverse drug reactions Special situations Human limit PV Search Strategy – full
  • 31. 31 Review Search Terms to Increase Precision intoxic*:de,ti,ab Products # of records without Additional Citations Screened Citations Relevant Citations Product 1 11 0 0 0 Product 2 6325 58 58 6 Product 3 13 0 0 0 Product 4 78 2 2 0 Product 5 143 3 3 0 Product 6 4243 9 9 0 Product 7 177 0 0 0 Product 8 18343 317 100 1 Product 9 29 0 0 0 Product 10 764 5 5 0 Total 30126 394 177 7 period of 3 years Please make sure all is documented!
  • 32. 32 Set up an Email Alert
  • 33. 33 Email Alert history can be exported
  • 34. 34 Email Alert history is auditable
  • 35. 35 Demo Please contact us at if you are interested in testing the PV wizard? embase@elsevier.com
  • 36. 36 Regular Reviews of the PV Search Strategy • Emtree updates three times per year • New search artefacts can be introduced • New indexing policies can be enforced • Always perform the review maintaining documented evidence that a specific search strategy consistently produces a record set meeting its pre-determined quality attributes
  • 37. Thank you! Any questions? Ivan Krstić, PhD Senior Product Development Manager Embase i.krstic@elsevier.com
  • 44. 44 Once a search is run from saved search space it gets displayed on results page as any other regular search. Import EMA’s‫‫‬MLM‫‫‬search