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Med dra Basics

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Med dra Basics

  1. 1. By MedDRA Basics Somnath Mondal Technical Associate (PVPI) Dept. of Clinical & Experimental Pharmacology School of tropical Medicine, Kolkata Dated 20th Nov continuance from 7th Nov,2013
  2. 2. Agenda 1. Introduction to MedDRA 2. ABC of Coding 3. Brief History of MedDRA Development 4. Scope of MedDRA 5. MedDRA Term vs. MedDRA Code 6. Basic of Structural Elements of the Terminology
  3. 3. What is MedDRA? Med = Medical D = Dictionary R = Regulatory A = Activities
  4. 4. MedDRA Definition MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
  5. 5. Requirements for MedDRA development • International applicability • Supported and used by both industry and regulators • Broader coverage of health data • Increased specificity • Structure to support analysis and presentation • Centrally and externally maintained • Compatible with IT systems and tools
  6. 6. Rationale For MedDRA Global Standardization and Universal Harmonization Across Regulatory Agencies Across Multinational Pharmaceutical Companies Necessary through out Product Life Cycle Necessary for Electronic Data Transfer Avoid Translation Distortions and Errors Across Countries Save Time: No need to cross reference through life time of product. No need to Translate Provide a classification for a wide range of clinical information, able to support for multiple medical product areas
  7. 7. Who participates in the MedDRA ? Representatives of Authorities and Pharmaceutical Companies from : Europe Japan United States European Union All reports (electronic) – January 2003  EudraCT SUSARs  Starting 2003 all severe single case safety reports going back to 1995 must be electronically submitted before the start of 2004.  Internal adverse event database Japanese Ministry of Health, Labour and Welfare  Required use of MedDRA for electronic filing start 1 October 2003  Proposed Rule for Safety Reporting Requirements (2003): FDA proposes to use MedDRA for post marketing safety reports MedDRA to be used in Periodic Infection & Safety Reports from April 2004 Observers: WHO, European Free Trade Association (EFTA), Nordic Countries (Denmark, Finland, Iceland, Norway and Sweden, Greenland), Canada, Australia
  8. 8. Sample of Current Regulators MedDRA
  9. 9. ABC of Coding
  10. 10. Why Do Medical and Drug Terms Need to Be Classified? Investigators report the same medical and treatment terms (called verbatim terms) in many different ways on the CRF/ ADR Reporting Form. In order to compare the frequency of adverse events in drug treatment versus non treatment groups the terms need to be classified into standardized terminology.
  11. 11. Why? • To facilitate the aggregation of verbatim reports into medically meaningful groupings so that they can be reviewed, analysed and communicated to the regulatory authorities. • To ensure the accurate, unbiased & consistent classification of CRF verbatim terms as reported by the investigators
  12. 12. What is Coding? Etymology: L, caudex, book The process of organizing information into categories, which are assigned codes for the purposes of sorting, storing, and retrieving the data. The process of transforming qualitative data into numerical data that can be entered into a computer file. Medical coding is essentially the process of assigning formal, standardized medical codes to patient medical records.
  13. 13. Why is Medical Coding? Medical coding is the transformation of narrative descriptions of diseases, injuries, and healthcare procedures into numeric or alphanumeric designations (that is, code numbers). The code numbers are detailed in order to Accurately describe the diagnoses (that is, what is wrong with the patient). and The procedures performed to test or correct these diagnoses. Because medicine is not always an exact science, codes were developed to identify all reasons for seeking healthcare.
  14. 14. Why do Medical Coding? If we search for "medical coding" on web , we will be driven to websites which deals with the ICD (9,10 etc.), CPT (Current Procedural Terminology) or HCPCS ( Healthcare Common Procedure Coding System) medical coding particularly deals with mapping various medical diagnosis and procedures to codes. Common uses of medical codes in healthcare include: Identifying symptoms that must be evaluated and to alert other healthcare professionals to life-threatening allergies. The services performed for reimbursement ReportingICD or CPT coding is out of scope here in this presentation. Helping with administrative functions such as staffing, scheduling, and adding or decreasing healthcare services Comparing facilities and planning for new services in underserved areas These mostly deals with medical insurance data and medical billing which is different from the coding in all phases of drug development.
  15. 15. Coding decisions during all phases of drug development directly impact submissions for New Drug Applications (NDAs), safety surveillance and product labelling. The success of a submission to the concerned regulatory authority (e.g. USFDA, EMEA or DCGI?) can be significantly impacted by the analysis of adverse events, medical history and concomitant medications. The analysis relies on the interpretation of what has been transcribed from the subject CRF (Case Report Form) or ADR reporting form. Ultimately, medical coding data permits access to health records according The coding of patient data is critical in the grouping, analysis, and to diagnoses and procedures for use in clinical care, research, education reporting of data. and for regulatory activities.
  16. 16. Brief History of MedDRA Development
  17. 17. Pre-MedDRA Era The essentiality and importance for an internationally accepted medical terminology, classification system was recognized at the First International Statistical Conference in Brussels in 1853 to evaluate medical data statistically to optimize and regulate public health issues globally. The standardization effort bore fruit in 1969 with the FDA’s use of the COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) dictionary. For the next quarter century, adverse event coding was dominated by WHOART (WHO Adverse Reaction Terminology, required by EU) and COSTART (required by FDA).
  18. 18. 1989 -UK MCA ( Medicines Control Agency (UK))identifies need for a single medical terminology to support new computer databases •1991–ADROIT ( Adverse Drug Reactions Online Information Tracking ) medical terminology created by UK MCA •January 1993 -identification of need for a medical terminology to support European Community drug regulatory system 2Q 1993 -Working party set-up of European regulators and pharmaceutical industry representatives to evaluate wider applicability of MCA terminology •November 1993 to October 1994 -Working party reviews and amends MCA terminology, now called MedDRA December 1993 -European Committee for Proprietary Medicinal Products approves MedDRA Project. •October 1994 -ICH recommends that MedDRA (version 1.0) should form basis of a new medical terminology
  19. 19. November 1994 –ICH Steering Committee released a draft (alpha) version (version 1.1) of terminology for review and evaluation . •March 1995 –ICH working group evaluated the alpha test results and evaluated suggested changes February 1996 -MedDRA Version 1.5 released for review in US and Japan •July 1997 –ICH approval of international terminology November 1998 –IFPMA (Trustee of ICH Steering Committee, holder of intellectual property) selected BDM International Inc. (a subsidiary of TRW Inc.) as the Maintenance and Support Services Organization (MSSO) •March 1999 –MedDRA version 2.1 released
  20. 20. Version HLGT HLT PT LLT 1.5 307 670 8,659 35,346 2.0 (1Q99) 334 1663 11,344 46,427 2.2 (3Q99) 3.0 (1QOO) NA 334 1653 3.1 (2Q 00) 4.0 (June 01) 333 1652 332 7.1 (November,2004) 8.0 (March,05) 8.1 (August,2005) 54,107 1683 16,102 56,981 NA 6.0 (March03) 7.0 (March, 04) 15,149 NA 5.1 (September,02) 6.1 (September,03) 47,892 NA 4.1 (November 01) 5.0 (March, 02 12117 1632 332 332 332 16,293 60,518 NA 1681 1683 16,449 61,204 16,559 61,704 16,751 62,348 16,976 62,950
  21. 21. 9.0 (March, 2006) 17,320 63,817 1682 17505 64,620 332 1682 17719 17,867 65,147 332 1,688  18,075 66,135 18,209 66,587  18483 67159 18641 67503 18,786  68,258  18,919  68,661  1,710  19,086  69,019  1710 1,713 19294 19,550 69524 70,177 1713 19737 70634 20057 71236 332 9.1 (January, 2007) 10.0 ( April, 2007) 10.1(September 1, 2007 ) 11.0 (March, 2008) 11.1 (1 September , 2008) 12.0 (March, 2009) 12.1 (September 2009) 13.0 (March 2010 ) 13.1 (September 2010) 14.0 (March 2011)  333 1699 335 1709 335 14.1 (1 September 2011  15.0 ( March, 2012) 15.1 ( September, 2012) 16 ( March, 2013) 65,605 335
  22. 22. Conditions before MedDRA
  23. 23.  Use of different types of terminologies Most organizations processing regulatory data used one of the international adverse drug reaction terminologies in combination with morbidity terminology. Europe United States European Union WHO-ART ICD-9 Japan J-ART J-MEDIS COSTART(C) ICD-9-CM Individualized Modified Terminologies to Suit Individual need. Major Technical Lacunae:  Lacked specificity of terms at the data entry level,  Provided limited data retrieval options (e.g., too few levels in the hierarchy, or capacity to retrieve data via one axis only), and  Ineffective handling of syndromes. Solution: Organizations with sufficient resources developed their terminologies to address some or all of these deficiencies. own “in-house”
  24. 24. The use of multiple terminologies raised several problems:  Use of different terminologies for various cycle: Phases of regulatory Complicates data retrieval and analysis, making it difficult to cross-reference data. For example, for Pre-registration clinical trials safety data had frequently been classified by using ICD terminology and for post-marketing surveillance using JART, WHO-ART, or COSTART.  Protracted International Communication: Using different terminologies in separate geographic regions impaired international communication and necessitated the conversion of data from one terminology to another. This data conversion had the potential to cause time delays and loss or distortion of data.  The use of multiple terminologies also affected communication between companies and clinical research organizations. It became increasingly difficult to manage the information required for product registration applications and to meet the time scale requirements for data exchange between regulatory authorities and the medical product industries.
  25. 25. Scope of MedDRA
  26. 26. The MedDRA Terminology applies to all phases of drug development (including biologicals but excluding animal toxicology). It also applies to the health effects and malfunction of devices (e.g., Catheter related infection and device leakage). The categories of “medical” terms are as follows:  symptoms Although social circumstances are not usually regarded as medical terms, they fall within signs the “medical” scope if they are relevant to the evaluation  of regulatory data diseases (e.g., in the assessment of clinical outcome of treatment in the light  diagnoses of exposure to  risk factors). therapeutic indications  names and qualitative results of investigations, Examples are: including pharmacokinetics the preferred term Foreign travel, the preferred term Occupational  surgical and the high level terms exposure to toxic agent and medical procedures Tobacco use and Bereavement.  medical/social/family history
  27. 27. The above defined terminology, was developed for regulators and the regulated medical product industry. data entry, retrieval, evaluation and presentation, and in both pre- and postmarketing phases of the regulatory process as follows: Hence, these groups can utilize the terminology for clinical studies reports of spontaneous adverse reactions and events  regulatory submissions regulated product information
  28. 28. Inclusion of terms from established terminologies The MedDRA Terminology includes references to other terminologies J-ART (1996) Preferred Terms, Included Terms COSTART (Fifth Edition  Preferred Terms, Glossary Terms WHO-ART© (3rd Quarter, 1998)  Preferred Terms, Included Terms  ICD-9 ICD-9-CM (4th revision) Not Specified HARTS (Release 2.2) The terminology was not developed as a metathesaurus and the hierarchies of these other terminologies are not subsets of it. Thus, data entry terms from other terminologies do not necessarily have the same PT (Preferred Term) in the MedDRA terminology as they did in their “parent” terminology. The hierarchies used for data retrieval and presentation are unique to the MedDRA.
  29. 29. Exclusion Criteria The exclusion criteria used in the development of the terminology do not necessarily limit the terminology’s expansion scope. 1. Since this is a medical terminology, the following terms used in regulatory affairs are out of scope:  Drug/product terminology  Equipment/device/diagnostic product terminology  Study design  Demographics (including patient sex, age, race and religion) 2. As its focus is on health effects in individual patients, the following are excluded:  Failure of devices (except for a small number of clinically relevant terms) Qualifiers that refer to populations rather than individual patients, e.g., rare, frequent 
  30. 30. Exclusion Criteria 3. Inclusion of terms is restricted to those within the scope of the terminology as defined above. Thus, when terms from a particular field (e.g., clinical pharmacology) are represented, only terms relevant to regulatory affairs should be included. 4. Numerical values associated with parameters are not included. 5. As a rule, descriptors of severity are not included in the terminology. Terms such as severe and mild are used only when pertinent to the specificity of the term (e.g., severe versus mild retardation).
  31. 31. OUT IN Diseases Diagnoses Signs Drug product terms failure terms Device Symptoms Therapeutic indications Investigation Equipment, device, names & Numericalqualitative results values for diagnostic product terms results Medical & surgical procedures Medical, social, family history Medication Error Terms study Severity descriptorsfrom: design Clinical trial COSTARTterms Population-level terms Patient demographicqualifiers WHO-ART© HARTS J-ART
  32. 32. MedDRA Term vs. MedDRA Code MedDRA Term: a word(s) Urticaria MedDRA Code: numbers representing each term Urticaria 10046735
  33. 33. MedDRA Code Unique numerical number assigned to each term in the dictionary : 8 digits •Starts with alphabetically 10000001, initially started •As terms added, codes assigned sequentially •These are just identification numbers; they don’t reflect the relational organization of the data files (unlike WHO-ART)
  34. 34. Development Philosophy • Based upon ANSI Z911 standard (American National Standards Institute standard for the development of a thesaurus) • Provided structure for development and future maintenance activities • Chosen to ensure the product would support the use of information technology • Internationally recognized standard 34
  35. 35. Basic of Structural Elements of the Terminology
  36. 36. Structural Elements of the Terminology Relationships between terms in the terminology fall into the following three categories: 1. Equivalence The equivalence relationship groups synonymous terms, or equivalent terms, under Preferred Terms. 2. Hierarchical The hierarchy provides degrees or levels of superordination and subordination. The superordinate term is a broad grouping term applicable to each subordinate descriptor linked to it. 3.Associative Associative groupings of terms are linked horizontally in the terminology.
  37. 37. Hierarchy Hierarchies are an important mechanism for flexible data retrieval and for the clear presentation of data. The five level hierarchy in this terminology provides options for retrieving data by specific or broad groupings, according to the level of specificity required. The Lowest Level Term (LLT) level provides maximum specificity.
  38. 38. Hierarchy System Organ Class (SOC) Link High Level Group Term (HLGT) Vertical High Level Term (HLT) Preferred Term (PT) Lowest Level Term (LLT) SSC or SMQ Detail discussion will be on later phases of discussion
  39. 39. Example: SOC Blood and lymphatic system disorders HLGT White Blood Cell Disorder HLT Neutropenias PT Neutropenia LLT Neutropenia aggravated LLT Neutropenia SSC Bone Marrow Depression and Secondary immunocompromised State
  40. 40. Example: SOC Cardiac Disorders HLGT Cardiac Arrhythmias HLT Rate and Rhythm of Disorders NEC PT Arrhythmia LLT Arrhythmia NOS LLT Arrhythmia LLT (Non-current) Other Specified Cardiac Dysrhythmias LLT Dysrhythmias
  41. 41. System Organ Class (SOC) Highest level of the hierarchy that broadest concepts for data retrieval. provides the SOCs identified or grouped by Anatomical or physiological system or manifestation site (Gastrointestinal disorder) Etiology (Infection of Infestation) Purpose (Surgical and Medical procedure)
  42. 42. Anatomical or physiological system or manifestation site or Anatomy (Body System) 1.Blood and lymphatic system disorders 9. Musculoskeletal and connective tissue disorders 10. Nervous system disorders 2.Cardiac disorders 11. Psychiatric disorders 3.Ear and labyrinth disorders 12. Renal and urinary disorders 4.Endocrine disorders 5.Eye disorders 6.Gastrointestinal disorders 7.Hepatobiliary disorders 8.Immune system disorders 13. Reproductive system and breast disorders 14. Respiratory, thoracic and mediastinal disorders 15. Skin and subcutaneous tissue disorders 16. Vascular disorders
  43. 43. Other (Cause/Association) System Organ Class (SOC) 1.Congenital, familial and genetic disorders 2.General disorders and administration site conditions 3.Infections and infestations 4.Injury, poisoning and procedural 6. Metabolism and nutrition disorders 7. Neoplasms benign, malignant and unspecified (including cysts and polyps) 8. Pregnancy, puerperium and perinatal conditions complications 5.Investigations 9. Social circumstances 10. Surgical and medical procedures
  44. 44. Etiology-based SOCs Supporting SOCs 1.Congenital, familial and genetic 1.Investigations disorders 2.Social circumstances 2.Neoplasms benign, malignant and 3.Surgical and medical procedures unspecified (including cysts and polyps) 3.Infections and infestations
  45. 45. High Level Group Term ( HLGT ) Subordinate only to System Organ Classes and superordinate descriptor for one or more HLTs related to anatomy, pathology, physiology, etiology or function. SOC Gastrointestinal disorders HLGT Dental and gingival conditions HLGT Gastrointestinal infections HLGT Gastrointestinal vascular conditions
  46. 46. High Level Term (HLT) Subordinate to HLGTs and super descriptors for the PTs linked to it. ordinate Categories linked to PTs by anatomy, pathology, physiology, etiology or function. Used solely presentation for data retrieval ( not a coding level). and
  47. 47. High Level Term SOC Gastrointestinal disorders   HLGT Gastrointestinal infections   HLT Intestinal infections HLT Gastrointestinal infections, site unspecified HLT Peritoneal infections
  48. 48. HLGT Vascular Hypertensive Disorder   HLT Accelerated and malignant Hypertension HLT Pregnancy Associated with hypertension HLT Hypertension complication HLT Portal hypertension HLT Pulmonary hypertension
  49. 49. Preferred Term   Each Preferred Term represents a single medical concept: • Clinical pathologic /etiologic data represented at PT level. • Unambiguous, self- descriptive. • No limit to the amount of LLTs that can be associated with a single PT ( A PT must have at least one LLT linked to it). • When a new PT is added an identical LLT is created automatically for data entry purposes.
  50. 50. • A PT must be linked to at least one SOC. Each path to a SOC from a PT should have exactly one HLT and HLGT (one route) PT → HLT → HLGT → SOC • PTs can be represented in multiple SOCs (multiaxality) • PTs may be groups with other PTs from the same SOC or different SOCs in SSC for cross hierarchy searches.
  51. 51. Example of PT PT Headache LLT (Non-current) LLT Head Pain LLT Head Pressure LLT Head aggravated Head dull LLT Head fullness LLT Headache LLT Head throbbing
  52. 52. Example of PT PT Dysponea LLT (Non-current) LLT Air Hunger LLT Breath Shortness Breathlessness LLT Breathing Difficult LLT Dysponea LLT Difficult breathing
  53. 53. Lowest Level Term (LLT) The most Specific level of terminology. Facilitate the data transfer from other terminologies. Facilitate the data entry by subjective choice. Use for Auto coding.
  54. 54. Lowest Level Term (LLT) Important Features: Each LLT is linked to only one preferred descriptor in the terminology. PT; this is its Has one of the following relationships to the Preferred Term (PT)  Synonyms  Lexical variants  Quasi-synonym  Sub-element  Identical LLT
  55. 55. Synonyms Different terms for the for the same descriptor same concept inherent in the PT For Example: PT Arthritis LLT Joint Inflammation
  56. 56. Lexical variants Different word forms for the same expression These include full names vs. abbreviations For Example: PT Acquired immunodeficiency syndrome LLT AIDS OR direct vs. inverted word order PT Biopsy tongue LLT Tongue biopsy
  57. 57. Quasi-synonym Terms that are not precisely the same meaning as another term, but are treated as synonymous in a given terminology. PT Otitis externa LLT Bilateral otitis externa Based on site and laterality descriptions both the terms are considered as Synonymous or equivalent clinically for medical product regulatory purposes.
  58. 58. Sub-element Sub-elements (of the parent PT) are represented by LLTs with more detailed information such as anatomic specificity. PT Contusion LLT Bruising of face LLT Bruising of leg
  59. 59. Identical LLT One LLT is identical to its PT for data entry purposes PT Arrhythmia LLT Arrhythmia NOS LLT Arrhythmia LLT (Non-current) Other Specified Cardiac Dysrhythmias LLT Dysrhythmias PT Dementia Alzheimer’s type LLT Dementia Alzheimer’s type In these instance, the LLT and parent PT have the same MedDRA code but appear at both levels.
  60. 60. Basic Rules in MedDRA PT: British Spelling LLT: British and American Spelling Medical Term: Dorland’s Medical Dictionary (29th Ed) Non-Medical Term: Merrian-Webster English Dictionary (29th Ed)
  61. 61. Thank you
  62. 62. But First, Some Definitions • Controlled vocabulary: a bunch of words, no relationships – But there is advantage if all users use the same terms to describe things • Taxonomy: is a controlled vocabulary with hierarchy • Thesaurus: is interchangeable with controlled vocabulary, also sometimes referred to as an ontology • Ontology: all of the above; think neural network with a bunch of relationships • MetaData: data about data (I really hate this definition, but it’s accurate) • MetaThesaurus – a collection of all of these things – EXAMPLE: UMLS
  63. 63. UMLS – Unified Medical Language System • More than 5 million terms or named entities • Divided into concepts, and each term has unique identifier • Not a vocabulary, but a mapping BETWEEN vocabularies • Vocabularies included in the UMLS: – – – – MeSH Headings in 8 languages (MeSH = Medical Subject Headings) ICPC-93 in 14 languages (ICPC = International Classification of Primary Care) WHO Adverse Drug Reaction Terminology in 5 languages SNOMED-2, SNOMED-3, and UK Clinical Terms (former Read Codes) (SNOMED = Systemized Nomenclature of Medicine) – ICD-10 in English and German (ICD = International Classification of Diseases)