Coding with Confidence

Transcription

1 Coding with Confidence Hilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited) Tomás Moraleda (Medical Officer MSSO) 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam Netherlands Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2 1

2 About MedDRA MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration ti of Pharmaceuticals for Human Use (ICH). The activities of the MedDRA Maintenance and Support Services Organization (MSSO) are overseen by an ICH MedDRA Management Board, which is composed of the six ICH parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Health Canada, and the WHO (as Observer). 3 Learning Objectives Describe how to code clinical safety data accurately and consistently with MedDRA Apply the principles described in the ICH-endorsed MedDRA Term Selection: Points to Consider document 4 2

3 Workshop Overview MedDRA refresher MedDRA Term Selection: Points to Consider document Browsing and coding tips and tricks Practical exercises Best practices 5 MedDRA Refresher 6 3

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. 7 Scope of MedDRA Not a drug dictionary Patient demographic terms Clinical trial study design terms OUT IN Diseases Diagnoses Signs Symptoms Therapeutic indications Investigation names & qualitative results Medical & surgical procedures Medical, social, family history Medication errors Product quality, device issues Terms from other terminologies Frequency qualifiers Numerical values for results Severity descriptors Not an equipment, device, diagnostic product dictionary 8 4

5 MedDRA Structure System Organ Class (SOC) (26) High Level Group Term (HLGT) (334) High Level Term (HLT) (1,717) Preferred Term (PT) (20,057) 057) Lowest Level Term (LLT) (71,326) MedDRA Version System Organ Classes Blood and lymphatic system disorders Cardiac disorders Congenital, familial and genetic disorders Ear and labyrinth disorders Endocrine disorders Eye disorders Gastrointestinal disorders General disorders and administration site conditions Hepatobiliary disorders Immune system disorders Infections and infestations Injury, poisoning and procedural complications Investigations Metabolism and nutrition disorders Musculoskeletal and connective tissue disorders Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Pregnancy, puerperium and perinatal conditions Psychiatric disorders Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Skin and subcutaneous tissue disorders d Social circumstances Surgical and medical procedures Vascular disorders 10 5

6 MedDRA hierachy SOC = Cardiac disorders HLGT = Cardiac arrhythmias HLT = Rate and rhythm disorders NEC LLT Arrhythmia NOS LLT Arrhythmia PT = Arrhythmia LLT (Non-current) Other specified cardiac dysrhythmias LLT Dysrhythmias 11 Non-Current Terms Non-current terms are flagged at the LLT level within MedDRA Not recommended for continued use Retained within the terminology to preserve historical data for retrieval and analysis Terms that are vague, ambiguous, out- dated, truncated, or misspelled Terms derived from other terminologies that do not fit MedDRA rules 12 6

7 MedDRA Codes Each MedDRA term assigned an 8-digit numeric code The code is non-expressive Codes can fulfill a data field in various electronic submission types (e.g., E2B) Initially assigned alphabetically by term starting with New terms are assigned sequentially Critical for upversioning 13 A Multi-Axial Terminology Multi-axial = the representation of a medical concept in multiple SOCs Allows grouping by different classifications Allows retrieval and presentation via different data sets Purpose of Primary SOC Determines which SOC will represent a PT during cumulative data outputs Is used to support consistent data presentation for reporting to regulators 14 7

8 A Multi-Axial Terminology (cont) SOC = Respiratory, thoracic and mediastinal disorders HLGT = Respiratory tract infections SOC = Infections and infestations HLGT = Viral infectious disorders HLT = Viral upper respiratory tract infections HLT = Influenza viral infections PT = Influenza 15 A Multi-Axial Terminology (cont) PTs in the following SOCs only appear in that particular SOC and not in others; i.e., they are not multi-axial: Investigations Surgical and medical procedures Social circumstances 16 8

9 Rules for Primary SOC Allocation PTs for diseases, signs and symptoms are assigned to prime manifestation site SOC Congenital and hereditary anomalies terms have SOC Congenital, familial and genetic disorders as Primary SOC Neoplasms terms have SOC Neoplasms benign, malignant and unspecified (incl cysts and polyps) as Primary SOC Exception: Cysts and polyps have prime manifestation site SOC as Primary SOC Infections and infestations terms have SOC Infections and infestations as Primary SOC 17 Primary SOC Priority If a PT links to more than one of the exceptions, the following priority will be used to determine primary SOC: 1 st : Congenital, familial and genetic disorders 2 nd : Neoplasms benign, malignant and unspecified (incl cysts and polyps) ps) 3 rd : Infections and infestations 18 9

10 Conditions vs. Investigations PT HLT HLGT SOC Pregnancy test Reproductive Endocrine Investigations positive hormone analyses investigations (incl sex hormones) Pregnancy Normal pregnancy, labour and delivery Pregnancy, labour, delivery and postpartum conditions Pregnancy, puerperium and perinatal conditions Be careful to distinguish between a condition and an investigation or a result of an investigation 19 MedDRA Term Selection: Points to Consider Document 10

11 MedDRA PTC Documents There are two PTC documents Term Selection Data Retrieval and Presentation Using MedDRA is a big step forward Using MedDRA the same way is a leap toward harmonization 21 Why Do We Need Coding Conventions? Differences in medical aptitude of coders Consistency concerns (many more choices to manually code terms in MedDRA compared to older terminologies) Even with an autoencoder, will still need manual coding and review 22 11

12 MedDRA Term Selection: Points to Consider An ICH-endorsed guide for MedDRA users Developed to promote medically accurate and consistent use of MedDRA in exchange of data (ultimately, for medically meaningful retrieval and analysis) Current version available on MedDRA MSSO Web site ( 23 MedDRA Term Selection PTC (cont) In cases with more than one option for selecting terms, the preferred option is identified but this does not restrict MedDRA users from selecting one of the alternative options. Organizations should be consistent in their choice of option. Section 4.1 Versioning g( (Appendix) Versioning methodologies Timing of version implementation 24 12

13 General Term Selection Principles Quality of Source Data Quality Assurance Do Not Alter MedDRA Always Select a Lowest Level Term Select Only Current Lowest Level Terms When to Request a Term Use of Medical Judgment in Term Selection Selecting More than One Term Check the Hierarchy Select Terms for All Reported Information, Do Not Add Information 25 Do Not Alter MedDRA MedDRA is a standardized terminology with a pre-defined term hierarchy Users must not make ad hoc structural alterations, including changing the primary SOC allocation If terms are incorrectly placed, or the concept is missing, submit a change request to the MSSO

14 Synonym Lists Can be derived from existing term lists or directly from verbatims For recurring, but unusual, verbatims onetime assignment to a MedDRA term Enforces consistency by limiting choices once MedDRA term is assigned Increases likelihood of autoencoding hit Natural outgrowth of a legacy data conversion Maintenance required 27 Synonym List Examples Verbatim LLT Comment Throbbing above temple Aching all over head Pulsing pain in head Headache Muscular pain in legs Myalgia of lower extremities LLT Myalgia of lower extremities is a better choice than LLT Muscular pain since it captures both the event and body site 28 14

15 Always Select a Lowest Level Term Lowest Level Term that most accurately reflects the reported verbatim information should be selected Degree of specificity may be challenging Example: Abscess on face select Facial abscess, not simply Abscess 29 Term Selection Points Diagnoses and Provisional Diagnoses with or without Signs and Symptoms Death and Other Patient Outcomes Suicide and Self-Harm Conflicting/Ambiguous/Vague Information Combination Terms Age vs. Event Specificity Body Site vs. Event Specificity Location Specific vs. Microorganism Specific Information Modification of Pre-existing Conditions Exposures During Pregnancy and Breast Feeding Congenital Terms Neoplasms Medical and Surgical Procedures Investigations 30 15

16 Term Selection Points (cont) Medication/Administration Errors, Accidental Exposures and Occupational Exposures Misuse, Abuse and Addiction Transmission of Infectious Agent via Product Overdose, Toxicity and Poisoning Device-related Terms Drug Interactions No Adverse Effect and Normal Terms Unexpected Therapeutic Effect Modification of Effect Social Circumstances Medical and Social History Indication for Product Use Off Label Use Product Quality Issues 31 Diagnoses and Provisional Diagnoses SINGLE DIAGNOSIS DEFINITIVE DIAGNOSIS Single diagnosis without signs and symptoms PROVISIONAL DIAGNOSIS Single provisional diagnosis without signs and symptoms Diagnosis (only possible option) Provisional diagnosis (only possible option) Example: Myocardial infarction select Myocardial infarction Example: Possible myocardial infarction select Myocardial infarction (select term as if definitive diagnosis) Similar principles apply for multiple diagnoses 32 16

17 Diagnoses and Provisional Diagnoses (cont) SINGLE DIAGNOSIS DEFINITIVE DIAGNOSIS PROVISIONAL DIAGNOSIS Single diagnosis with signs/ Single provisional diagnosis with symptoms signs/symptoms Preferred: Diagnosis only Preferred: Provisional diagnosis and signs/symptoms Example: Anaphylactic Example: Possible myocardial reaction with rash, dyspnea, infarction with chest pain, hypotension, and laryngospasm dyspnea, diaphoresis select select Anaphylactic Myocardial infarction Chest reaction pain, Dyspnea, and Diaphoresis 33 Diagnoses and Provisional Diagnoses (cont) SINGLE DIAGNOSIS DEFINITIVE DIAGNOSIS Single diagnosis with signs/ symptoms Alternate: Diagnosis and signs/symptoms PROVISIONAL DIAGNOSIS Single provisional diagnosis with signs/symptoms Alternate: Signs/symptoms only (as provisional diagnosis may change Example: Anaphylactic reaction Example: Possible myocardial with rash, dyspnea, hypotension, infarction with chest pain, and laryngospasm select dyspnea, diaphoresis select Anaphylactic reaction, Rash, Chest pain, Dyspnea, and Dyspnea, Hypotension, and Diaphoresis Laryngospasm 34 17

18 Diagnoses and Provisional Diagnoses (cont) Always include signs/symptoms not associated with diagnosis Reported LLT Selected Myocardial infarction, chest pain, dyspnea, diaphoresis, ECG changes and jaundice Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction) 35 Conflicting/Ambiguous/ Vague Information First, attempt to obtain more specific information Reported LLT Selected Comment Hyperkalemia with a serum potassium of 1.6 meq/l GU pain Congestion Serum potassium abnormal Pain Unevaluable event LLT Serum potassium abnormal covers both of the reported concepts (note: serum potassium of 1.6 meq/l is a low result, not high) GU could be either genito-urinary or gastric ulcer. Since pain i is definite, select LLT Pain Congestion reported alone is vague; this can refer to multiple organs and physiologic processes 36 18

19 Combination Terms One condition is more specific than the other Reported Arrhythmia due to atrial fibrillation LLT Selected Atrial fibrillation A MedDRA combination term is available Reported Retinopathy due to diabetes LLT Selected Diabetic retinopathy 37 Combination Terms (cont) If splitting provides more clinical information, select more than one term In all cases of combination terms, apply medical judgment Reported Diarrhea and vomiting Wrist fracture due to fall LLT Selected Diarrhea Vomiting Wrist fracture Fall 38 19

20 Location Specific vs. Microorganism specific infection No MedDRA term including both microorganism and anatomic location Reported Respiratory chlamydial infection LLT Selected Chlamydial infection Respiratory infection Respiratory infection Chlamydial infection Preferred Option Comment Represents both microorganism specific infection and anatomic location Represents location-specific infection Represents microorganism specific infection 39 Body Site vs. Event Specificity MedDRA term includes body site and event information Reported LLT Selected Skin rash on face Rash on face No MedDRA term that includes body site and event. Event information has priority. Reported LLT Selected Comment In this instance, Skin rash on chest Skin rash there is no available term for a skin rash on the chest 40 20

21 Body Site vs. Event Specificity (cont) No MedDRA term that includes body site and event. Exercise judgment; body site may take priority. Reported LLT Selected Comment Cyanosis at injection site Injection site reaction Cyanosis implies a generalized disorder. In this example, selecting LLT Cyanosis would result in loss of important medical information and miscommunication. 41 Procedure and diagnosis are reported If a procedure is reported with a diagnosis, the preferred option is to select terms for both the procedure and diagnosis. Alternatively, select a term only for the diagnosis. Reported LLT Selected Preferred Option Comment Selecting term for the procedure may indicate severity of the condition Liver transplantation due to liver Liver transplantation Liver injury injury Liver injury 42 21

22 EU PV Directive: Impacts on MedDRA and MTS:PTC Document Directive Covered Topics Impacts on MedDRA and MTS:PTC document ISO ICSR [E2B (R3)] Patient Reporting Safety Signal Detection Responsibilities New CT 3 (Clinical Trials Safety Reporting) 44 Drug Inform 22

23 EU PV Directive Drug Information Association 45 EU Pharmacovigilance Directive Chapter 17 Member States should operate a pharmacovigilance system to collect information that is useful for the monitoring of medicinal products, including information on suspected adverse reactions arising from use of a medicinal product within the terms of the marketing authorisation as well as from use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors, and suspected adverse reactions associated with occupational exposure Drug Inform 23

24 Amended Definition of Adverse Reaction Noxious and unintended effects resulting from authorized use of a medicinal product at normal doses There is regulatory interest in special situations Off label use Overdose Misuse Abuse Medication errors Occupational exposure MedDRA covers most such concepts and can expand as needed through Change Requests MTS:PTC provides definitions and coding examples. 47 Medication Errors 48 24

25 Medication Errors (cont.) Appendix B in MedDRA Introductory Guide To assist in understanding and appropriate use of medication error and product quality issue terms in regulatory reporting Medication error descriptions developed by FDA and MSSO Note that Occupational Exposures has been added to section name 49 Medication Errors (cont.) Medication/Administration Errors Medication errors reported with clinical consequences Medication errors and potential medication errors reported without clinical consequences Medication errors in the context of labeled interactions ti Do not infer a medication error 50 25

26 Medication Errors and Product Quality Issues There can be overlap between product quality issues and medication errors An example of both a product quality issue and a medication error is provided 51 Accidental Exposures 52 26

27 Occupational Exposures 53 Occupational Exposures (cont.) 54 27

28 Misuse, Abuse and Addiction 55 Misuse Terms in MedDRA Currently 7 terms in MedDRA Note that misuse is considered intentional LLT Unintentional device misuse is therefore not a misuse concept 56 28

29 Misuse (cont.) 57 Misuse (cont.) 58 29

30 Abuse 59 Abuse (cont.) 60 30

31 Addiction 61 Addiction (cont.) 62 31

32 Expansion of Medication Error Terms Prior to MedDRA Version 8.0, only one term existed - PT Medication error Medication error section expanded in v8.0 Added HLGT Medication errors in SOC Injury, poisoning and procedural complications HLT Maladministrations HLT Medication errors due to accidental exposures HLT Medication monitoring errors HLT Overdoses HLT Medication errors NEC 63 Off Label Use 3.27 Off Label Use The concept of off label use relates to situations where the product is intentionally used for a medical purpose not in accordance with the authorized product information

33 Off Label Use (cont.) 65 Off Label Use (cont) 66 33

34 Off Label Use (cont) 67 FDA- Defined FDA- Defined Coding Errors 34

35 FDA-Defined Coding Errors Missed Concepts All medical concepts described after the product is taken should be coded d Example: The patient took drug X and developed alopecia, increased LFTs and pancreatitis. Manufacturer only codes alopecia and increased LFTs (missed concept of pancreatitis) Example: The patient took drug X and developed interstitial nephritis which later deteriorated into renal failure. Manufacturer only codes interstitial nephritis (missed renal failure concept) Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER 69 FDA-Defined Coding Errors (cont) Soft Coding Selecting a term which is both less specific and less severe than another MedDRA term is soft coding Example: Liver failure coded as hepatotoxicity or increased LFTs Example: Aplastic anemia coded as unspecified anemia Example: Rash subsequently diagnosed as Stevens Johnson syndrome coded as rash Acknowledgement: Dr. Toni Piazza-Hepp, Office of Surveillance and Epidemiology, CDER 70 35

36 Animal Pharma: Challenging Verbatims Deer ria Big fat ugly cow Hippo tension Wanted to take an elephant dump Mousy feeling in chest Beasting R arm Menstrual clams Seeing gpeople p in room, seeing chickens at window Seeing stars and chicken farting Patient recently began new job where he works around chicken wings and barbecue sauce 71 MedDRA Data Retrieval and Presentation: Points to Consider 36

37 Data Retrieval and Presentation PTC An ICH-Endorsed Guide for MedDRA users on Data Output Developed by an ICH Expert Working Group Provides data retrieval and presentation options for industry or regulatory purposes Objective is to promote understanding of implications that various options for data retrieval have on accuracy and consistency of final output Current version available on MedDRA MSSO Web site ( 73 Data Retrieval PTC: Points Addressed General Principles Quality of Source Data Documentation of Data Retrieval and Presentation Practices Do Not Alter MedDRA Organization-Specific Data Characteristics Characteristics of MedDRA that Impact Data Retrieval and Analysis MedDRA Versioning General Queries and Retrieval Standardised MedDRA Queries Customized Searches 74 37

38 Definition of SMQ Result of cooperative effort between CIOMS and ICH (MSSO) Groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., related to medical condition or area of interest Intended to aid in case identification SMQs in Production - Examples As of Version 16.0, a total of 90 in production Agranulocytosis Anaphylactic reaction Cerebrovascular disorders Convulsions Depression and suicide/self-injuryinjury Hepatic disorders Ischaemic heart disease Lack of efficacy/effect Peripheral neuropathy Pregnancy and neonatal topics Pseudomembranous colitis Rhabdomyolysis/myopathy Severe cutaneous adverse reactions Systemic lupus erythematosus Chronic kidney disease Malignant lymphomas Hypersensitivity 76 38

39 Thank You 39

40 Practical Experience Applying Coding Principles and Conventions Hilary Vass (Global Clinical Dictionary Manager AstraZeneca UK Limited) Tomás Moraleda (Medical Officer MSSO) Overview Examples: assessing verbatims and selecting MedDRA terms Interactive Ex.s Pitfalls and solutions Tips for coding medication errors and product quality issues and for handling abbreviations Sharing best practices 2 1

41 Assessing the reported term First step: Consider what is being reported Is it a clinical condition - Diagnosis, sign or symptom? Is it an indication? Is it a test result? Is it trauma? Is it a procedure? Is it a medication error? Is it a product quality issue? Is it a social circumstance? Is it a device issue? Is it a procedural complication? The type of report will influence the way you search for a suitable LLT. It may indicate in which SOC you expect to find the closest match. Is it a combination of these? 3 MedDRA Browsing Tips A good browser is a key component Use top-down and bottom-up approaches First, try using actual words from reporter Consider synonyms, e.g., Liver and Hepatic Use word stems, e.g., Pancrea Search different word orders, and, or, etc. Use available resources for difficult verbatim terms (web search, medical dictionaries, colleagues) Check the hierarchy Look at the neighbors 4 2

42 Example 1: Complications and Outcomes Death due to liver failure secondary to Hep B liver cirrhosis 5 Example 1: Assessing the Verbatim Death due to liver failure secondary to Hep B liver cirrhosis Hep B = original medical condition Liver cirrhosis = complication of Hep B Liver failure = complication of liver cirrhosis and Hep B, proximal cause of death Death = outcome 6 3

43 Example 1: Term Selection Death due to liver failure secondary to Hep B liver cirrhosis Check for applicable combination terms none Hep B: LLT Hepatitis B SOC Infections and infestations Do not use non-current LLT Hep B (PTC 2.5) Query if abbreviation is unacceptable Would not need to code if patient t known to have had Hep B at baseline (PTC 3.5.5) 7 Example 1: Term Selection, cont. Liver cirrhosis, Liver failure: LLT Liver cirrhosis and LLT Liver failure both SOC Hepatobiliary disorders Neither term is adequately expressed by the other or by LLT Hepatitis B Death: outcome Do not code (PTC 3.2.1) 8 4

44 Example 2: Complications and Provisional Diagnoses Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel perforation) 9 Example 2: Assessing the Verbatim Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel perforation) 10 5

45 Example 2: Term Selection Sepsis leading to shock (from spontaneous bacterial peritonitis or bowel perforation) Check for applicable combination terms: LLT/PT Septic shock found Better than coding to both LLT/PT Sepsis and LLT/PT Shock (preserves relationship) SBP or bowel perforation: Potential causes of the septic shock Uncertain if both conditions were actually present (likely a differential diagnosis) 11 Example 2: Term Selection, cont. Code both provisional diagnoses for best capture: LLT Spontaneous bacterial peritonitis PT Peritonitis bacterial SOC Infections and infestations LLT Bowel perforation PT Intestinal perforation SOC Gastrointestinal disorders 12 6

46 Examples 1 & 2: Actual Verbatim Death due to liver failure secondary to Hep B liver cirrhosis and sepsis from spontaneous bacterial peritonitis or bowel perforation 13 Ex. 1: Complications. Which ones would you choose? Retinal disease from HIV with near total blindness (R and L) LLT Retinal damage LLT Retinal disorder LLT HIV disease LLT Blindness LLT HIV retinopathy LLT Blindness, both eyes 14 7

47 Ex. 1: Suggested Terms Retinal disease from HIV with near total blindness (R and L) LLT Retinal damage (goes to injury SOC) LLT Retinal disorder (combo term available) LLT HIV disease (combo term available) LLT Blindness (not the most specific LLT) LLT HIV retinopathy (good combo term) LLT Blindness, both eyes (most specific term for this reported condition) 15 Ex.1: Why not also code the HIV? If patient known to have had HIV at baseline (can t tell here) Combination term was available Check hierarchy for PT AIDS retinopathy: Primary SOC: Infections and infestations, HLT Retroviral infections Secondary SOCs: Eye disorders, Immune system disorders Coded event will display in infections SOC 16 8

48 Ex. 2: Lab Tests. Which ones would you choose? Testing showed increased serum creatinine and BUN, with increased BUN/creatinine ratio. a) LLT Increased serum creatinine, LLT BUN increased b) LLT Increased serum creatinine, LLT BUN increased, LLT Blood urea nitrogen/creatinine ratio increased c) LLT Renal function tests NOS abnormal 17 Ex. 2: Suggested Terms Testing showed increased serum creatinine and BUN, with increased BUN/creatinine ratio. a) LLT Increased serum creatinine, LLT BUN increased (does not capture the abnormal ratio) b) LLT Increased serum creatinine, LLT BUN increased, LLT Blood urea nitrogen/creatinine ratio increased c) LLT Renal function tests t NOS abnormal (do not lump together per PTC ; loss of specificity; also not NOS, as abnormalities were specified) 18 9

49 Pitfalls and Solutions, 1 Do not lose information by lumping Do not add information by coding to a diagnosis that is not explicitly stated in the verbatim Reread verbatim carefully, resist any internal or external pressure to code to unstated diagnoses If the physician who actually saw the patient was not comfortable committing to a diagnosis, why should you be? 19 Pitfalls and Solutions, 2 Terms that sound like something they aren t (eg, LLT Blood urine) ) Read through the other PTs under that HLT LLT/PT Blood urine vs. LLT/PT Blood urine present (lab test name vs. lab test result) Not finding the most specific term Combine bottom-up and top-down searches, use judicious translations For osteoporosis due to advanced age, select LLT/PT Senile osteoporosis, not LLT/PT Osteoporosis 20 10

50 Pitfalls and Solutions, 3 Autocoder specials (ie, inappropriate terms selected by autocoder) Review all weight-based autocoding carefully, apply medical judgment Inadvertently sacrificing detail at the PT level to capture detail in an LLT Check hierarchy For intermittent migraine headaches, use LLT Migraine headache PT Migraine, not LLT Intermittent headache PT Headache 21 Ex. 3: Medication Errors and Product Quality Issues Eye clinic nurse reported accidentally using a vial of an unpreserved injectable medication on more than one patient and complained that the warning on the label stating that it was for single use only was too small to read. One of the patients developed eloped an injection site infection

51 Tips for Coding Medication Errors and Product Quality Issues Spend some time reading through the available terms and hierarchies, for familiarity Read the LLTs to better understand the meaning of the PTs: For example, PT Wrong technique in drug usage process includes LLTs like Wrong injection technique, Tablet crushed incorrectly, and Inhalation not administered correctly. Code all elements: medication errors, product quality issues, and associated adverse events 23 Ex.3: Assessing the Verbatim Eye clinic nurse reported accidentally using a vial of an unpreserved injectable medication on more than one patient and complained that the warning on the label stating that it was for single use only was too small to read. One of the patients developed eloped an injection site infection

52 Ex. 3: Medication Error Which option would you choose? Eye clinic nurse reported accidentally using a vial of an unpreserved injectable medication on more than one patient. a) LLT Medication error b) LLT Circumstance or information capable of leading to a medication error c) LLT Multiple l use of single-use product d) LLT Poor quality drug administered 25 Ex. 3: Suggested Terms Eye clinic nurse reported accidentally using a vial of an unpreserved injectable medication on more than one patient. a) LLT Medication error (not specific) b) LLT Circumstance or information capable of leading to a medication error (error occurred) c) LLT Multiple l use of single-use product d) LLT Poor quality drug administered (presumes poor quality) 26 13

53 Ex. 3: Product Quality Issue Which option would you choose? Eye clinic nurse complained that the warning on the label stating that it was for single use only was too small to read. a) LLT Product label issue b) LLT Product quality issue c) LLT Product label missing text 27 Ex. 3: Suggested Terms Eye clinic nurse complained that the warning on the label was too small to read. a) LLT Product label issue (note: label refers to the actual label on the product) b) LLT Product quality issue (too general) c) LLT Product label l missing i text t (text t was there, just too small) 28 14

54 Ex. 3: Adverse Effect Which option would you choose? One of the patients developed an injection site infection. a) LLT Infection b) LLT Injection site infection c) LLT Eye infection 29 Ex. 3: Suggested Terms One of the patients developed an injection site infection. a) LLT Infection (too general) b) LLT Injection site infection c) LLT Eye infection (presumes eye) 30 15

55 Ex. 4: Overdose & Self-Harm Patient with reactive depression due to the recent passing of his spouse attempted suicide by intentionally taking a handful of his diuretic tablets. 31 Ex.4: Assessing the Verbatim Patient with reactive depression due to the recent passing of his spouse attempted suicide by intentionally taking a handful of his diuretic tablets

56 Ex. 4: Depression/Loss Which options would you choose? Patient with reactive depression due to the recent passing of his spouse 1) LLT Depression or LLT Reactive depression? 2) LLT Death of spouse or no code at all? SOC Social circumstances 33 Ex. 4: Suggested Terms Patient with reactive depression due to the recent passing of his spouse 1) LLT Depression or LLT Reactive depression? LLT Reactive depression (same PT, but more specific) 2) LLT Death of spouse or no code at all? SOC Social circumstances See PTC 3.23 (generally do not enter as AE; could enter under medical/social history; consult local conventions) 34 17

57 Ex. 4: Overdose/Self-Harm Which options would you choose? Patient attempted suicide by intentionally taking a handful of his diuretic tablets. t 1) LLT Attempted suicide or LLT Suicidal behavior? 2) LLT Diuretic abuse or LLT Drug overdose deliberate self-inflicted or LLT Drug toxicity due to intentional overdose? 35 Ex. 4. Suggested Terms Patient attempted suicide by intentionally taking a handful of his diuretic tablets. 1) LLT Attempted suicide (exact match) LLT Suicidal behavior (different PT) 2) LLT Diuretic abuse (refers to something else) LLT Drug overdose deliberate self-inflicted LLT Drug toxicity due to intentional overdose (no toxicity was reported) 36 18

58 Ex. 5. Exposures While preparing to administer of a blood transfusion, a nurse stabbed herself with the needle and subsequently developed acute hepatitis B, with dark urine, fever, loss of appetite, yellow skin and mono-arthritis. Lab tests showed HBsAg 12 weeks later. Further investigation revealed that transfusion blood was contaminated with HBV and that the nurse had received one only dose of HBV vaccine. Ex. 5. Assessing verbatims While preparing to administer of a blood transfusion, a nurse stabbed herself with the needle and subsequently developed acute hepatitis B, with dark urine, fever, loss of appetite, yellow skin and mono-arthritis. Lab tests showed positive HBsAg 12 weeks later. Further investigation revealed that transfusion blood was contaminated with HBV and that the nurse had received one only dose of HBV vaccine. 19

59 Ex. 5. Adverse Event. Which ones would you choose? Acute hepatitis B dark urine..? Bilirubin urine Urine bilirubin increased Choluria Appetite lost Skin?.. Yellow skin Jaundice Monoarthritis Investigations HBsAg 39 Ex. 5. AE. Suggested terms Acute hepatitis B dark urine..? Bilirubin urine Urine bilirubin increased Choluria (since it is an observation, not a test) Appetite lost Skin?.. Yellow skin Jaundice Monoarthritis Investigations HBsAg 40 20

60 Ex. 5 (AE). [ Dx + S/S = Dx only ] Single definitive diagnosis with signs/symptoms: Preferred diagnosis only Acute hepatitis B dark urine..? Bilirubin urine Urine bilirubin increased Choluria Appetite lost Skin?.. Yellow skin or Jaundice? Monoarthritis Investigations HBsAg note that, despite hepatitis B has pain in joints, a localized monoarthritis is not typically associated with it) 41 Ex. 5 (AE). Investigation consistent with Dx When investigation results are reported with a diagnosis, select only a term for the diagnosis if investigation results are consistent with the diagnosis. Acute hepatitis B dark urine..? Bilirubin urine Urine bilirubin increased Choluria Appetite lost Skin?.. Yellow skin Jaundice Monoarthritis Investigations HBsAg 42 21

61 Ex. 5. Exposure. Which would you choose? Transmission of an infectious agent via product Transfusion-transmitted infectious disease? Hepatitis B immunisation Incomplete course of vaccination Occupational exposure while preparing product for administration Needle stick/puncture (under PT Injury associated with device) Accidental injury Accidental exposure while administering drug dug Exposure to device contaminated with body fluid (under PT Exposure to contaminated device) Exposure to body fluid Exposure via blood 43 Ex. 5. Exposure. Table 1 SOC HLGT HLT PT LLT Genrl- Complications associated with Complications associated Injury associated with Needle stick/puncture device with device NEC device Infec- Ancillary infectious topics Infectious transmissions Transmission of an Transmission of an infectious infectious agent via product agent via product Inj&P- Exposures, chemical injuries and poisoning Exposures to agents or circumstances NEC Occupational exposures Transmission of an Transfusion-transmitted infectious agent via product infectious disease Exposure to body fluid Exposure to contaminated device Occupational exposure to product Exposure to body fluid Exposure to device contaminated with body fluid Occupational exposure while preparing product for administration Pathways and sources of Exposure via blood Exposure via blood exposure Inj&P- Injuries NEC Non-site specific injuries Injury Accidental injury NEC Inj&P- Medication errors Accidental exposures to Accidental exposure to Accidental exposure while product product administering drug Maladministrations Incomplete course of Incomplete course of vaccination vaccination Surg- Therapeutic procedures and Immunisations Hepatitis B immunisation Hepatitis B immunisation supportive care NEC 44 22

62 Ex. 5. Exposure. Suggested terms Transmission of an infectious agent via product Transfusion-transmitted infectious disease? Hepatitis B immunisation Incomplete course of vaccination Occupational exposure while preparing product for administration Needle stick/puncture (Under PT Injury associated with device) Accidental injury Accidental exposure while administering drug dug Exposure to device contaminated with body fluid (under PT Exposure to contaminated device) Exposure to body fluid Exposure via blood 45 Ex. 5. Exposure. Table 2. SOC HLGT HLT PT LLT Genrl Complications associated with device Complications associated with Injury associated with device Needle stick/puncture device NEC Hepat Hepatic and hepatobiliary disorders Cholestasis and jaundice Jaundice Jaundice Infec Ancillary infectious topics Infectious transmissions Transmission of an infectious agent via product Transmission of an infectious agent via product Transmission of an infectious agent via product Transfusion transmitted infectious disease Infec Viral infectious disorders Hepatitis viral infections Acute hepatitis B Acute hepatitis B Inj&P Exposures, chemical injuries and Exposures to agents or Exposure to body fluid Exposure to body fluid poisoning circumstances NEC Exposure to contaminated device Exposure to device contaminated with body fluid Occupational exposures Occupational exposure to product Occupational exposure while preparing product for administration Pathways and sources of exposure Exposure via blood Exposure via blood Inj&P Injuries NEC Non site specific injuries NEC Injury Accidental injury Inj&P Medication errors Accidental exposures to product Accidental exposure to product Accidental exposure while administering drug Maladministrations Incomplete course of vaccination Incomplete course of vaccination Inv Hepatobiliary investigations Liver function analyses Bilirubin urine Bilirubin urine Urine bilirubin increased Urine bilirubin increased Inv Microbiology and serology Virus identification and serology Hepatitis B surface antigen HBsAg investigations Metab Appetite and general nutritional Appetite disorders Decreased appetite Appetite lost disorders Musc Joint disorders Arthropathies NEC Monarthritis Monoarthritis Renal Urinary tract signs and symptoms Urinary abnormalities Choluria Choluria Skin Epidermal and dermal conditions Dermal and epidermal conditions Yellow skin Yellow skin NEC Surg Therapeutic procedures and supportive Immunisations Hepatitis B immunisation Hepatitis B immunisation care NEC 46 23

63 Ex. 6. Do Not Add Information Neutropenic patient under chemotherapy treatment presented with retinitis with cotton like lesions in fundoscopy. One week later, patient was hospitalized with high fever, nuchal rigidity and obnubilation. CSF was positive for Candida app, and hematogenous candidiasis was suspected. 47 Ex. 6. Which would you choose. Chemotherapy Neoplasm malignant Neutropenia Retinitis Candida retinitis Cotton wool spots Fundoscopy abnormal High temperature Nuchal rigidity Obnubilation Candidiasis Disseminated candidiasis Candida test positive Candidal meningitis 48 24

64 Ex. 6 Suggested terms Chemotherapy Neoplasm malignant Neutropenia Retinitis? Candida retinitis? Cotton wool spots Fundoscopy abnormal High temperature Nuchal rigidity Obnubilation Candidiasis? Disseminated candidiasis? Candida test positive Candidal meningitis 49 Ex. 7. About versioning A 49-year-old female developed intestinal graft-versus-host disease (GVHD) which prolonged hospitalization. The patient received her first study platelet transfusion on 08 July The patient s medical history includes NK leukemia and vaginal hysterectomy

65 A 49-year-old female developed intestinal graft-versus-host disease (GVHD) which prolonged hospitalization. The patient received her first study platelet transfusion on 08 July The patient s medical history includes NK leukemia and vaginal hysterectomy. 51 New terms and re-coding Reported event GVHD (unspec.) GVHD (as a whole). No GVHD skin diferentiation. GVHD liver GVHD intestine Undetermined Skin Liver Intestine 52 26

66 New terms and re-coding Reported event GVHD (unspec.) GVHD (as a whole). No GVHD skin diferentiation. GVHD liver GVHD intestine Undetermined Skin Liver Intestine 53 Version update v13.1 v14.0 V14.1 v15.0 v15.1 Study A data lock 2 MedDRA versions per year (March and September) Study C Study B data lock data lock Integrated analysis: MedDRA v15.1 Pharmacovigilance 54 27

67 Ex. 8. Procedure and diagnosis are reported A 75-year-old male diagnosed with coronary insufficiency developed anginal pain on 21 Feb 2010 resulting in hospitalization while enrolled in a randomized, open-label study. The patient s medical history is significant for triple bypass graft surgery 2006, postural hypotension and stage D prostate carcinoma. On 26 Feb 2010, the patient underwent percutaneous transluminal coronary angioplasty with stent placement in the right coronary and proximal left anterior descending arteries. 55 Ex. 8. Assessing the Verbatim A 75-year-old male diagnosed with coronary insufficiency developed anginal pain on 21Feb10 resulting in hospitalization while enrolled in a randomized, open-label study. The patient s medical history is significant for triple bypass graft surgery 2006, postural hypotension and stage D prostate carcinoma. On 26Feb10, the patient underwent percutaneous transluminal coronary angioplasty with stent placement in the right coronary and proximal left anterior descending arteries

68 Ex. 8. Time profile and term types A 75-year-old male diagnosed with.. coronary insufficiency.... developed anginal pain on 21Feb10 resulting in hospitalization while enrolled in a randomized, openlabel study. The patient s medical history is significant for triple bypass graft surgery 2006, postural hypotension and stage D prostate carcinoma. On 26Feb10, the patient underwent percutaneous transluminal coronary angioplasty with stent placement in the right coronary and proximal left anterior descending arteries. 57 Tips for Handling Abbreviations Train investigators to avoid reporting abbreviations Consider context t in the verbatim that t might disambiguate the abbreviation Consider using the ARGH Biomedical Acronym Resolver to look up various meanings of acronyms and their frequency of use in Medline Longer acronyms might be specific enough to code Consider specifying that a certain medical acronym dictionary will be used (>1 meaning query) 58 29

69 Funny Verbatims Trauma of right knee during skiing in FRANCE Endorses smoking marijuana once per day Just her time to go Tongue stud Brain feels like a lava lamp Fungus left feet Feeling like Gumby Loss of sensibility in pubic area 59 Summary In this workshop we: Reviewed key principles in the MedDRA Term Selection: Points to Consider document Learned practical approaches to coding consistently, accurately, and with confidence Engaged in practical Ex.s and shared best practices 60 30

70 Learner Assessment Learner Assessment Concerning the pre-defined primary SOC allocations in MedDRA, which of the following statements is true? a. They should never be changed b. Coders should choose whichever primary SOC they prefer when coding c. Data reviewers should alter the primary SOCs to fit the product s AE profile d. They should be changed only through the MSSO s Change Request process 62 31

71 Learner Assessment According to the preferred option in the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim Abdominal cramps, vomiting, diarrhea, (food poisoning), Athlete s foot? a. Abdominal cramps, Vomiting, Diarrhea, Food poisoning b. Acute gastroenteritis c. Food poisoning, Athlete s foot d. Athlete s foot 63 Learner Assessment According to the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim Markedly elevated ALT and AST after starting study drug? a. Hepatitis drug-induced b. Transaminases increased c. ALT increased, AST increased d. Hypertransaminasemia 64 32

72 Learner Assessment According to the MTS:PTC, what would be the appropriate LLT selection(s) for the verbatim Patient expired because of a drug administration error (gave wrong antiarrhythmic)? a. Cardiac death, Drug toxicity b. Wrong drug administered c. Expired drug used d. Death, Drug administration error 65 Thank you! (? please) 33