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Best Practices on Medical Coding in MedDRA

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Best Practices on Medical Coding in MedDRA

  1. 1. PREVIOUS NEXTCopyright ©2012 BioPharm Systems, Inc.Best Practices for Medical Coding with MedDRAA summary of diverse client practiceOctober 10, 2012• Caroline HalseyDirector of Project Management,EMEABioPharm Systems• Rodney Lemery, MPH, PhDVice President, Safety andPharmacovigilanceBioPharm Systems1
  2. 2. PREVIOUS NEXT• Welcome and introduction• Issues and Decisions around Coding Practice– Who should code– Which terms to code– How to ensure quality– How to optimise technology to save time– Re-coding after new MedDRA versions• Issues and Decisions around Analysis– Data analysis and grouping– SMQ Definition and Use– Signal DetectionAgenda2 Copyright ©2012 BioPharm Systems, Inc.
  3. 3. PREVIOUS NEXTWelcome & Introductions3 Copyright ©2012 BioPharm Systems, Inc.Rodney LemeryVice President of Safety andPharmacovigilanceBioPharm Systems• Head of Safety/PV practice since2007– Expertise in managing all phases andstyles of clinical trials– Leads the team that implements,supports, and enhances Oracle’sTMS, Argus, AERS and EmpiricaProducts• Extensive TMS and medical codingimplementation experience– 10+ years of experienceimplementing TMS and coding toolsused in clinical data managementand safetyCaroline HalseyDirector of Project Management, EMEABioPharm Systems• Over 13 years of clinical operationsmanagement and data managementexpertise- Experience delivering validatedtechnology and associated trainingto sponsors and CROs- Building cross-functional andinternational working relationshipsto enable the development ofefficient processes- Currently supporting enhancementsto the medical coding system for amajor global pharma company
  4. 4. PREVIOUS NEXTWelcome & IntroductionsSafety and Pharmacovigilance Practice ServicesImplementationsManage implementations of OracleTMS, Custom medical coding systemdevelopment, Argus Safety, AERS andEmpirica Topics.IntegrationsBuild interfaces between TMS, Argusand other clinical systems.TrainingDevelop and/or deliver standard andcustom training classes and materialsfor various dictionaries of interest.Process GuidanceProvide insight, advice, and solutionsto specific medical/drug coding orsafety related issues.4 Copyright ©2012 BioPharm Systems, Inc.
  5. 5. PREVIOUS NEXTCopyright ©2012 BioPharm Systems, Inc.Issues and Decisions around Coding Practice• Caroline HalseyDirector of ProjectManagement, EMEABioPharm Systems5
  6. 6. PREVIOUS NEXTWho should code and how?Balance time and money6 Copyright ©2012 BioPharm Systems, Inc.
  7. 7. PREVIOUS NEXTWho should code and how?Balance time and money7 Copyright ©2012 BioPharm Systems, Inc.
  8. 8. PREVIOUS NEXTWho should code and how?Balance time and money8 Copyright ©2012 BioPharm Systems, Inc.
  9. 9. PREVIOUS NEXTWho should code and how?Balance time and money9 Copyright ©2012 BioPharm Systems, Inc.
  10. 10. PREVIOUS NEXTWho should code?• HCP– The hiring of health care professionals (RN, LVN/LPN,Pharmacists, Dieticians, Public Health Practitioners, ResearchMDs others)• Non-HCP with Coding Committee Review• This method is very common assuming that HCP are presentin the central coding committee10 Copyright ©2012 BioPharm Systems, Inc.
  11. 11. PREVIOUS NEXTWhich terms to code• ICH regulatory requirement– coding of reported Adverse Events and Serious Adverse Events to theMedDRA dictionary when submitting electronic reports• FDA– anticipated MedDRA requirement but it is not yet CFR• Our client base (“Industry Standard” ~64 pharma, OTC, biotechand device companies)– Code at least Adverse Events– Optionally code:• Medical History• Lab• Con-Med Indications11 Copyright ©2012 BioPharm Systems, Inc.
  12. 12. PREVIOUS NEXTCRO•Flexible resourcing•Not experienced with codingconventions of every sponsor•Quality: sponsor oversight/ QCvia in-house team acceptingcodes that CRO proposesDe-centralised team in-house(Split by TA, Phase,Clinical vs Safety)•If therapeutically or phasealigned may have another roleas well as coding, thereforenot coding experts?•If busy with coding then likelyto be busy with otherresponsibilities at the sametime•Quality: Less consistencybetween coding clinical andsafety data if separate codingteams•How implement QC checksacross TA/ Phase?Centralised in-house team(Coding all Clinical and Safetyterms)•Code both clinical trials andsafety data so should reduceSAE reconciliation issues•Consistent coding across TAs•Ensure sufficient people tomeet pharmacovigilance andclinical trial timelines•Quality: one person propose acode and another accept12 Copyright ©2012 BioPharm Systems, Inc.Organisation of the Coding Team
  13. 13. PREVIOUS NEXTCRO•Flexible resourcing•Not experienced with codingconventions of every sponsor•Quality: sponsor oversight/ QCvia in-house team acceptingcodes that CRO proposesDe-centralised team in-house(Split by TA, Phase,Clinical vs Safety)•If therapeutically or phasealigned may have another roleas well as coding, thereforenot coding experts?•If busy with coding then likelyto be busy with otherresponsibilities at the sametime•Quality: Less consistencybetween coding clinical andsafety data if separate codingteams•How implement QC checksacross TA/ Phase?Centralised in-house team(Coding all Clinical and Safetyterms)•Code both clinical trials andsafety data so should reduceSAE reconciliation issues•Consistent coding across TAs•Ensure sufficient people tomeet pharmacovigilance andclinical trial timelines•Quality: one person propose acode and another acceptCombination may be the ideal: sponsor accepts codes that CROproposes or QCs % of codes13 Copyright ©2012 BioPharm Systems, Inc.Organisation of the Coding Team
  14. 14. PREVIOUS NEXTCRO•Flexible resourcing•Not experienced with codingconventions of every sponsor•Quality: sponsor oversight/ QCvia in-house team acceptingcodes that CRO proposesDe-centralised team in-house(Split by TA, Phase,Clinical vs Safety)•If therapeutically or phasealigned may have another roleas well as coding, thereforenot coding experts?•If busy with coding then likelyto be busy with otherresponsibilities at the sametime•Quality: Less consistencybetween coding clinical andsafety data if separate codingteams•How implement QC checksacross TA/ Phase?Centralised in-house team(Coding all Clinical and Safetyterms)•Code both clinical trials andsafety data so should reduceSAE reconciliation issues•Consistent coding across TAs•Ensure sufficient people tomeet pharmacovigilance andclinical trial timelines•Quality: one person propose acode and another acceptCombination may be the ideal: sponsor accepts codes that CROproposes or QCs % of codes14 Copyright ©2012 BioPharm Systems, Inc.Organisation of the Coding Team
  15. 15. PREVIOUS NEXT15 Copyright ©2012 BioPharm Systems, Inc.Training, training, training– Highlight new terms or changesin each MedDRA versionDocument company standards– Therapeutic area standards?– Phase I, II, II, IV conventions?– Cross-therapy area or cross-phase– Coding Steering Team could improveconsistency across Therapeutic Areas orPhasesEnsuring quality – Training and Documentation
  16. 16. PREVIOUS NEXTEnsuring Quality – QC and QA• In-stream– 100% for adverse events– Could be lower % for medical history and con med indications• Quality Control– Four-eyes process:• Proposer + Acceptor• Proposer could be @ CRO and Acceptor @ sponsor• Quality Assurance– QC of the Acceptor stage via review of listings• Regularly review and discuss real examplesof coding solutions and errors amongst thecoding team16 Copyright ©2012 BioPharm Systems, Inc.
  17. 17. PREVIOUS NEXTTime savers - technology• Short term expenditure ontechnology can lead to long termsavings in human resources– Automate where possible and enablehuman coders to focus on where theycan add value• Technology can include:– Autocoding based on synonym lists– Coding distinct terms– Automation of work assignment17 Copyright ©2012 BioPharm Systems, Inc.
  18. 18. PREVIOUS NEXTAutocoding• Auto-encoding reported verbatim terms to previouslycoded data is an option within many commercial codingsystems• Can involve:– Company synonym lists that grow over time e.g. synonyms of LLTCardiac pain/PT Angina pectoris:• Shooting pain in heart• Heart pain• Twinges in heart– Autocoding algorithm – normalisation of text and removingerroneous characters• E.g. “Ache/pain ongoing on heart” transforms to “Pain heart” and isthen coded to “Cardiac pain”18 Copyright ©2012 BioPharm Systems, Inc.
  19. 19. PREVIOUS NEXTCode every term?“Cold” Query“Cold” Query“Cold” Query19 Copyright ©2012 BioPharm Systems, Inc.
  20. 20. PREVIOUS NEXTOr code distinct terms?“Cold” Query20 Copyright ©2012 BioPharm Systems, Inc.
  21. 21. PREVIOUS NEXTTerms out of context• Risk with autocoding, coding distinct terms and withcentralised coding team …reviewing terms out of context– “Chest pain” especially in clinical trials• No other information is present to indicate if this isgeneral chest pain, cardiac, GI related, respiratoryrelated etc.– “Chest pain” in Post Marketing• Hospitalisation report indicates an ECG performed withindications of cardiac arrhythmias and a likely mild MI.• Best practice: manual review of autocoded adverse eventcoding• Consider: BUT does context cause bias/ lead to assumptionsin coding?21 Copyright ©2012 BioPharm Systems, Inc.
  22. 22. PREVIOUS NEXTCoding Med Hist, Labs and AE terms all in one place• Is the verbatim “ALT increased” on the AE form thesame as “ALT increased” on the Lab form?• If you coded “ALT increased” to “Alanine aminotransferaseincreased” in the lab data then it will code the AE verbatimthe same• Is this acceptable?• Should you query the AE term for a definitive or provisional diagnosisrather than the sign/symptom?22 Copyright ©2012 BioPharm Systems, Inc.
  23. 23. PREVIOUS NEXTWork Assignment• Automation of work assignment enables team leaders to addvalue elsewhere rather than spend time assigning individual’swork• Use technology to assign priorities per person/ role/ group• Then adjust priorities as needed:• Safety vs clinical terms• One clinical trial vs others23 Copyright ©2012 BioPharm Systems, Inc.
  24. 24. PREVIOUS NEXTCoding conventions• Most of our clients use the MSSO MedDRA Points to Consideras the premier coding convention guide• In clinical trials, there may be protocol specific codingguidelines in the data management plan (or equivalent)– E.g. A clinical trial of a product treating “Tuberculosis”• Verbatim terms come in as “Plaque positive”– Term vague• For this study only the verbatim term will be mapped to “Mycobacteriumtuberculosis complex test positive”24 Copyright ©2012 BioPharm Systems, Inc.
  25. 25. PREVIOUS NEXTRecoding after each newMedDRA version• Per MSSO: “the decision to re-code historical data is left to thediscretion of each individual company” (MSSO, 2012)• The EMA has, in some cases, required users to recode data back to 1995.• “During the 60 day period (allowed duration for dictionaryversioning), it was envisioned that organisations would review thechanges in MedDRA and make what changes they (the organization)thought were necessary. Typically, this involves reviewing and re-coding LLTs that have become non-current, reviewing new directmatches to the verbatims and, if resources allow, reviewingmedically “better” terms. These steps are not required but are atypical best practice of many organizations” (MSSO, 2012)25 Copyright ©2012 BioPharm Systems, Inc.
  26. 26. PREVIOUS NEXTRecoding after each newMedDRA versionOngoing studies• Ensures consistency ofcoding within a study• Requires expenditureon technology toenable the recodingOngoing and lockedstudies• Ensures dataconsistency, sobeneficial whenaggregating data (ISSISE)• To maintain record ofwhat was originallyreported need tomaintain audit trails• Requires expenditureon technology toenable the recodingPharmacovigilancecases• DSUR/PSUR data tablelistings of LLT or PTterms will beconsistent among thedata (be it pre or postmarketingauthorisation)• PT consistencyrequired forreproducible SMQusage in signaldetection26 Copyright ©2012 BioPharm Systems, Inc.
  27. 27. PREVIOUS NEXTCopyright ©2012 BioPharm Systems, Inc.Issues and Decisions around Analysis• Rodney Lemery, MPH,PhDVice President, Safety andPharmacovigilanceBioPharm Systems27
  28. 28. PREVIOUS NEXTData Retrieval and Analytical Method1. Identify Research Questions• Partner with statistician and clinical leads to ensure a well formed andappropriate research question given the quality and quantity of codeddata2. Develop MedDRA Search Strategy, may include:• SMQs• SOCs with/without secondary• Grouping terms (HLT/HLGT)• Custom Search - Use own SMQs for targeted surveillance3. Retrieve cases based on strategy4. Assess data to answer research question28 Copyright ©2012 BioPharm Systems, Inc.
  29. 29. PREVIOUS NEXTData Retrieval and Analytical Method• Assume that we have the AE datacollected to the left.• We could ask what is the mostfrequently experienced category ofmedical issue in our data?• We could also ask are there anysuspected or confirmed cases of“Acute pancreatitis” in our data?29 Copyright ©2012 BioPharm Systems, Inc.
  30. 30. PREVIOUS NEXTData Retrieval and Analytical Method• When displayedby SOC theanswer to ourinitial researchquestion is“Gastrointestinaldisorders” with afrequency of9/16 = 56.25%30 Copyright ©2012 BioPharm Systems, Inc.
  31. 31. PREVIOUS NEXTData Retrieval and Analytical Method• When displayed byHLGT the answer toour initial researchquestion is“Gastrointestinal signsand symptoms” with afrequency of 5/16 =31.25%31 Copyright ©2012 BioPharm Systems, Inc.
  32. 32. PREVIOUS NEXTData Retrieval and Analytical Method• When displayedby HLT theanswer to ourinitial researchquestion is“Nausea andvomitingsymptoms” witha frequency of3/16 = 18.75%32 Copyright ©2012 BioPharm Systems, Inc.
  33. 33. PREVIOUS NEXTStandardised MedDRA Queries• Groupings of relevant MedDRA terms at PT level torepresent a particular area of interest, for dataretrieval & analysis• Provided by MSSO with each new MedDRA version• Used to identify cases of interest in your data (Mozzicato,2007)33 Copyright ©2012 BioPharm Systems, Inc.
  34. 34. PREVIOUS NEXTStandardised MedDRA Queries• Rationale behind development of SMQs (CIOMS,2004)• The size (~ 18 000 PTs) and complexity of MedDRAterminology carries the risk that• Different users may select differing sets of terms while trying toretrieve cases related to the same drug safety problem• Globally standardised search queries/analysis will give broaderacceptance in signal detection methods34 Copyright ©2012 BioPharm Systems, Inc.
  35. 35. PREVIOUS NEXTStandardised MedDRA Queries• SMQs contain PT and LLT terms for the “…signs,symptoms, diagnoses, syndromes, clinical findings,laboratory and disorders, other test data, etc, relatedto the condition of interest…” (Mozzicato, 2007)35 Copyright ©2012 BioPharm Systems, Inc.
  36. 36. PREVIOUS NEXTStandardised MedDRA Queries• Some are hierarchical in nature:36 Copyright ©2012 BioPharm Systems, Inc.• Others are not:
  37. 37. PREVIOUS NEXTFeatures of SMQs – Broad vs Narrow• SMQ relations with dictionary terms may be identified asbroad or narrow.• Narrow terms: highly likely to represent the condition of interest• Narrow search retrieves narrow terms• Broad terms: help to identify all possible cases• Including some that may prove to be of little or no interest• A broad search retrieves broad terms• Algorithms within SMQs are used to further define cases of suspectedmedical conditions• Based on rules defined in the algorithm by the MSSO• Processed programmatically during a search operation37 Copyright ©2012 BioPharm Systems, Inc.
  38. 38. PREVIOUS NEXTExample of MedDRA SMQ• Acute Pancreatitis SMQ Terms and AlgorithmA B C38 Copyright ©2012 BioPharm Systems, Inc.A OR (B AND C)
  39. 39. PREVIOUS NEXTData Retrieval and Analytical Method• When using theSMQ for oursecond researchquestion, theanswer is 539 Copyright ©2012 BioPharm Systems, Inc.
  40. 40. PREVIOUS NEXTUse of MedDRA in Signal Detection• In terms of spontaneous safety data reporting and signaldetection methods, use of MedDRA can have a dynamic impacton the statistical results• In our data above, let’s suppose our research question was “Dopersons exposed to our product report ‘Acute Pancreatitis’ at agreater rate than those not taking our product?”• The next slides look at the ability to use the MedDRA hierarchy tocalculate a disproportionality score in an attempt to answer this question• We will borrow from the field of epidemiology (specifically case-control studies) and calculate a type of Odds Ratio (Waller, vanPuijenbroek, Egberts, & Evans, 2004)40 Copyright ©2012 BioPharm Systems, Inc.
  41. 41. PREVIOUS NEXTMedDRA Analysis“Acute Pancreatitis”2x2 Table Person ExposedtoProduct XBackground ofchoice (usuallypersons NOT takingProduct X)Experiencing “Acute Pancreatitis” 30 (A) 10 (C)Not Experiencing “Acute Pancreatitis” 214 (B) 234 (D)41 Copyright ©2012 BioPharm Systems, Inc.Reporting Odds Ratio = AD----- = 3.28BCInterpretation: Patients exposed to product X are 3.28 times more likely toreport “Acute Pancreatitis” than patients not exposed toproduct X
  42. 42. PREVIOUS NEXTCompany MedDRA Queries• A trend we are now seeing are companies using theirown SMQs not found in the MedDRA dictionary– Company or Custom MedDRA Queries (CMQ)– A list of targeted PT and LLTs is gathered into an over-archingclinical construct• Each PT/LLT is assigned a Broad or Narrow context and if required, complexalgorithms can also be used• The data is then mined for cases using the CMQ inexactly the same manner as an SMQ42 Copyright ©2012 BioPharm Systems, Inc.
  43. 43. PREVIOUS NEXTCompany MedDRA Queries• Here we define a case of“Hyperglycemic Events”as the following:– Any report from CategoryA– OR– A report from Category Cwith at least 2 items fromCategory B43 Copyright ©2012 BioPharm Systems, Inc.
  44. 44. PREVIOUS NEXTMedDRA Analysis Using CMQ“Hyperglycemic Events”2x2 Table Person ExposedtoProduct XBackground ofchoice (usuallypersons NOT takingProduct X)Experiencing Hyperglycemic events asdefined in CMQ181 (A) 184 (C)Not Experiencing Hyperglycemic eventsas defined in CMQ63 (B) 60 (D)44 Copyright ©2012 BioPharm Systems, Inc.Reporting Odds Ratio = AD----- = 0.94BCInterpretation: Patients exposed to product X are no more likely to reportHyperglycemic events than patients not exposed to product X
  45. 45. PREVIOUS NEXTSummary• Quality: implement QC and QA oversight• Cost: invest in technology/ automation wherepossible to allow personnel to focus on the “valueadd”• Time: invest in technology• Identify research questions and SMQ researchmethodology• May include CMQs45 Copyright ©2012 BioPharm Systems, Inc.
  46. 46. PREVIOUS NEXTWays to Engage…• For those ready• Proof of concept or scope discussions to see if BioPharmmay be able to assist you in assessing your coding oranalysis methods• For those not quite ready• Schedule early engagement calls to provide guidance onsimilar projects• For those in the midst of a process re-engineering• Refine your approach with guidance calls to review yourapproach and evaluate if BioPharm’s input might beuseful to your organisation46 Copyright ©2012 BioPharm Systems, Inc.
  47. 47. PREVIOUS NEXTReferences• Brown, E.. (2004). Using MedDRA Implications for Risk Management. Drug Safety2004; 27 (8)• CIOMS. (2004). Development and Rational Use of Standardised MedDRA Queries(SMQs). WHO, Geneva, CIMS• Mozzicato, P. (2007). Standardised MedDRA Queries Their Role in SignalDetection. Drug Safety. 30 (7): 617-619• MSSO.. (2012). Retrieved fromhttp://www.meddramsso.com/public_faq_meddra.asp on October 1st, 2012• Waller, P., van Puijenbroek, E., Egberts, A., and Evans, S. (2004). The reportingodds ratio versus the proportional reporting ratio: ‘deuce’. Pharmacoepidemiologyand drug safety. 13: 525–52647 Copyright ©2012 BioPharm Systems, Inc.
  48. 48. PREVIOUS NEXTQ&A• Please feel free to enter your questions in thechat area of the screen48 Copyright ©2012 BioPharm Systems, Inc.
  49. 49. PREVIOUS NEXTContact Us• North America Sales Contact:• Rod Roderick• rroderick@biopharm.com• +1 877 654 0033• Europe/Middle East/Africa Sales Contact:• Rudolf Coetzee• rcoetzee@biopharm.com• +44 (0) 1865 910200• General Inquiries:• info@biopharm.com49 Copyright ©2012 BioPharm Systems, Inc.

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