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Embase for pharmacovigilance: Search and validation March 22 2017

The document discusses the creation and validation of pharmacovigilance search strategies using Embase, emphasizing the importance of literature monitoring in detecting adverse drug reactions. It outlines regulatory requirements, provides tips for effective search strategies, and explores precision and recall in search results. Additionally, it highlights the features of Embase and its advantages in compliance with regulatory mandates for medicine safety monitoring.

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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 StrategyCreation 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 definedas 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 forLiterature 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 (GVPModule 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 forLiterature Monitoring
  • 8.
    8 Importance of SearchStrategy 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 forLiterature 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 Precisionand 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 aGOLD 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 buildsearch 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 areEmtree 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 Fieldcodes :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 (Basedon Industry Best Practices)
  • 18.
    18 'paracetamol'/'drug toxicity','drug interaction','adversedrug 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 SearchStrategy – 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 SearchStrategy – part 3 [adverse drug reaction] 11.7M [drug subheadings] [drug]/[subheadings] OR ([drug names] AND [adverse drug reaction])
  • 22.
    22 [drug names] PV SearchStrategy – 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 SearchStrategy – 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 SearchStrategy – 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','druginteraction','adverse drug reaction' PV Search Strategy – Part 1: Subheadings
  • 26.
    26 Drug name andvariants '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 ('adversedrug 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,tiOR 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','adversedrug 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 Termsto 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 anEmail Alert
  • 33.
    33 Email Alert historycan be exported
  • 34.
  • 35.
    35 Demo Please contact usat if you are interested in testing the PV wizard? embase@elsevier.com
  • 36.
    36 Regular Reviews ofthe 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? IvanKrstić, PhD Senior Product Development Manager Embase i.krstic@elsevier.com
  • 38.
  • 39.
  • 40.
  • 41.
  • 42.
  • 43.
  • 44.
    44 Once a searchis run from saved search space it gets displayed on results page as any other regular search. Import EMA’s‫‫‬MLM‫‫‬search