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Vigi flow -_data_entry

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Vigi flow -_data_entry

  1. 1. VigiFlow – Introduction and data entry Somnath Mondal Technical Associate (PvPI) STM-AMC Dept. of Clinical & Experimental Pharmacology Kolkata, India June,14, 2013
  2. 2. Agenda • Module I –VigiBase – recapture –VigiFlow • General information and background • Data entry • Hands on… • Module II –VigiFlow – advanced concepts • Advanced report handling • Search and Statistics Somnath Mondal, STM-AMC Kolkata, India
  3. 3. What is VigiFlow? A web based report management tool that simplifies report management. Complete ICSR Management System ICSR (Individual Case Safety Report) – A synonym for ADR report. VigiFlow can be used by any authority or company as a complete database for report management and storage.
  4. 4. Complete ICSR Management System –Data entry –Assessment –Storage –Retreival (e.g. for follow-ups) –Communication with other parties • It is web-based • It is E2B compatible Somnath Mondal, STM-AMC Kolkata, India
  5. 5. VigiFlow is not primarily a tool for reporting to the UMC, but reports can easily be sent through the system. Somnath Mondal, STM-AMC Kolkata, India
  6. 6. Advantages: General Aspects: • Less delay in ADR reporting – Sending a report is as fast as a mouse click • Improved report quality – Error checks and lexicons – Help texts – Mandatory fields • (Predefined values in drop-down boxes) • Outputs in several formats – E2B, PDF, Excel All factors that increase the report quality. Somnath Mondal, STM-AMC Kolkata, India
  7. 7. Technical: • Internationally recognised standards – E2B report format – WHO-ART and ICD or MedDRA – WHO Drug Dictionary • One server installation – maintained in Uppsala – No local installation needed – Immediate access to new versions of both VigiFlow and terminologies/dictionaries • Sharing of costs and ideas – Development and maintenance
  8. 8. History • 2001 – Swissmedic needed a new pharmacovigilance system – Support for primary notifier reporting – 7 regional centres – 4 languages • A project was started – “ADR Pilot”: – Version 0.1 – Summer 2003 – Version 1 – Autumn 2003 • E2B compatible version complying with international standards • With this version the first report was entered – by Alex in Ghana Somnath Mondal, STM-AMC Kolkata, India
  9. 9. Success Story: Swissmedic usage • As mentioned Swissmedic has been using VigiFlow for all their report management since summer 2004. – They have connected 7 regional centres, including one specialized centre – There is no more paper based reporting from physicians directly to Swissmedic • But companies are still sending reports on paper… – They are today managing twice the amount of reports compared to 2004 without increase in staff Somnath Mondal, STM-AMC Kolkata, India
  10. 10. VigiFlow NC NC NC Company RC RC RC RC Flexibility of VigiFlow Example 1 Example 3 Example 2 NCRC Two strong centres in a country, on set up as NC, one as RC. Both the RC and the NC enters and assesses their own reports. The RC sends its reports to the NC for committment into the database of finialized reports. NC One NC (regional PV centres not connected to VigiFlow Only the National PV Centre is connected to VigiFlow. All reports are entered and assessed by NC personnel. (Not necessarily at the same location.) VigiFlow VigiFlow NC RC RC RC A strong NC with several RC sharing the work of data entry. The RCs enter the primary data and sends the report to the NC. The NC performs all assessments and supports the RCs in their work. VigiFlow Example 4 Companies with a need for ICSR management can also use VigiFlow. CompanyVigiFlow Magnus Wallberg, UMC PvPI
  11. 11. Magnus Wallberg, UMC Flow of reports in VigiFlow Report repository Regulatory Authority Regional Centre 1 Regional Centre 2 External organizations E2B (XML) PDF WHO database - VigiBaseE2B (XML)
  12. 12. Magnus Wallberg, UMC Pros and cons with VigiFlow Pros • Combination of structured and free-text fields to encourage complete data entry • Integrated dictionaries and terminologies ensures correct coding • Easy communication between national and regional centres • No need for local server upkeep and back-ups • Seamless transmission of reports to WHO/UMC Cons • Server (with national data) in another country might be against national regulations • Needs Internet access - at least 0.5 Mbit/s for a good experience • Not 100% adaptable to local ideas of how it “should work”
  13. 13. Magnus Wallberg, UMC Terminologies used • Terminology for coding reactions and indications – WHO-ART / ICD • Easy reporting and analysis • Dictionary for coding drugs – WHO Drug Dictionary • Products from many countries as well as herbal products
  14. 14. Report input module
  15. 15. Main parts Report handling search and statistics exit new report Send report list reports Somnath Mondal, STM-AMC Kolkata, India
  16. 16. Main parts: report handling With this button you create a new report This button lists all reports that are “under assessment” Somnath Mondal, STM-AMC Kolkata, India
  17. 17. Create a new report Click this button to create a new report Standard case: – A normal report with one patient taking a drug and suffering from an ADR Parent-child case: – A report where a parent has taken a medicine and the child is suffering from the ADR Somnath Mondal, STM-AMC Kolkata, India
  18. 18. Sections of the report input module 0. Report Information 1.Patient 2.Tests and procedures 3. Relevant Medical Histories 4.Past drug therapy 5.Reactions 6. Drugs 7. Assessment 8. Overview 9. Save A. Print Report 0. Report Information 1.Patient 5.Reactions 6. Drugs Somnath Mondal, STM-AMC Kolkata, India Mandatory
  19. 19. General report information • The first section of the report • Collects information about –General report data –Sender of the report –Primary source(s) Somnath Mondal, STM-AMC Kolkata, India
  20. 20. General report data Date received at Regional Center dd mm ccyy Date received at National Center Report Title Type of Report Spontaneous Study Literature Seriousness criteria Country of occurrence Somnath Mondal, STM-AMC Kolkata, India
  21. 21. Warning Mandatory field Tab. Metronidazole- Pancreatitis This text will appear in the report listing and enable you to identify your report , Fluoxetine- Serotinin Syndrome or Suppose Serious If case is serious, reason for seriousness must be given Reason for Seriousness All the criteria apply as the case as a whole and should not be confused outcome (s) of individual reaction (s)/ event (s) Medically confirmed if not initially from health professional. Only to be completed if the primary reporter was a lawyer, consumer, or other non-health professional. Somnath Mondal, STM-AMC Kolkata, India
  22. 22. Somnath Mondal, STM-AMC Kolkata, India
  23. 23. General report information – sender details • Information about the organization sending the report to – Type of organization (Sender) Pharmaceutical Company Regional Pharmacovigilance Center Health professional Regulatory Authority other Regional Pharmacovigilance Center – Name of sender and senders report number to be entered in admin chapter Somnath Mondal, STM-AMC Kolkata, India
  24. 24. • World wide unique number – If you are the first receiver of the report this should be left blank. It will be automatically filled with your report number. – If you are not the first receiver, fill in the report number of the original sender of the case If the report has no worldwide unique report number both the fields should left empty. The worldwide unique number then be automatically assigned when a report Id is generated. This number will be remain unchanged in all subsequent transmissions. If the report has worldwide unique number, enter as either authority report number or company report number. This number should remain unchanged for subsequent transmission. Somnath Mondal, STM-AMC Kolkata, India
  25. 25. Somnath Mondal, STM-AMC Kolkata, India
  26. 26. General report information – primary source(s) • Information about primary source – Name and details of for example physician – Literature reference • To be filled in if a literature case – Information about study details • To be filled in if report from study • The entire section is repeatable if there are more than one primary source • Possibility to save a reporter for later re-use Somnath Mondal, STM-AMC Kolkata, India
  27. 27. Somnath Mondal, STM-AMC Kolkata, India Patient information • Birth date, age or age group • Initials • Weight • Height • Sex • Information on patient death – Death date – Death cause – Autopsy information
  28. 28. This filed will be calculated automatically if age of onset is present. The age group definitions used in this application are Neonate <= 1 month infant <= 4 years child <= 11 years adolescent <=16 years adult <= 69 years elderly > 69 years Onset age This filed will be automatically be calculated from „onset date of reaction‟ and „date of birth‟ if both those dates are completely entered & differ. If „onset date of reaction‟ and „date of birth‟ is identical or incomplete, an onset date may be entered. Populate “unknown” if the initial of the initials of the patient is unknown. (New amendment in 4.3 version of vigiflow) Verify content Move to next section decade Year month week day hour Search for ICD-10 term Somnath Mondal, STM-AMC Kolkata, India
  29. 29. Tests and procedures • Allows for entry of test data • Free text field • Structured information – The preferred option – Test type entered as free text or by selection from a drop down. In appearance the test sections differs somewhat from the rest of the tool since there has been a wish to always see all information for comparison reasons.
  30. 30. Free text entry Add another “coded” test Add test type as free text or from drop down (Only MedDRA term if MedDRA is used as terminology) Add another test result, more than one can be added at the same time Copy dates if several tests have been done at the same date(s) PassiveActive
  31. 31. Relevant medical history • In this section medical history that might be of importance is recorded • Free text field • Structured information – Medical history term (ICD-10) – Start and stop date – Comment
  32. 32. Free text entry 3 medical history entries added Active entry Details about active entry
  33. 33. Past drug therapy • In the past drug therapy section information about previous medications is recorded –Drug name –Indication (if available) –Reaction (if applicable)
  34. 34. 2 past drug therapies entered Name of drug (free text) Indication (coded with term lookup)Reaction (coded with term lookup)
  35. 35. Free text entry 3 medical history entries added Details about active entry
  36. 36. Reactions • Reporter’s comments • List of coded reactions • Details about each individual reaction • Causality assessment
  37. 37. List of reactions 5 reactions added Use the up arrow to move the most important reaction to the top
  38. 38. Reaction entry Use the reaction lookup tool to add the correct term (described later) Enter a new term only if you could not find an appropriate term in the term lookup tool
  39. 39. Comments provided from primary source (in free text) Coded reactions The reaction in bold is the “active” reaction below Details about “active” reaction Relatedness assessment – entered for each drug/reaction combination This field should be used to include the primary reporter‟s comments on diagnosis Causality assessment or other issues considering relevant. Error Maximum 500 characters This field should reflect the wording about the event as received from the primarimary reporter. (Original text unless to avoid misunderstandings.) Error Maximum 200 characters
  40. 40. Drugs • List of coded drugs • Details about each individual drug • Causality assessment
  41. 41. List of drugs Use the up arrow to move the most important drug to the top Add one more drug to the report 3 suspected and 1 concomitant drug added
  42. 42. Drug entryUse the drug lookup tool to add the correct drug
  43. 43. Coded drugs The drug in bold is the “active” drug below Details about “active” drug Relatedness assessment – entered for each drug/reaction combination
  44. 44. Drug reaction relatedness (Relatedness assessment) • Information on the relatedness of the drugs and reactions coded on a report – Relatedness information • In VigiFlow – WHO Causality – Information on recurrence • Information entered in a “simple” matrix Remove a relatedness with the trash if NO relatedness at all
  45. 45. Assessment • A number of “mainly” free text fields –Case narrative –Sender’s comments • Your comments –Sender’s diagnosis • Coded in ICD10 or MedDRA with the term lookup tool –References • Any references to other sources, like literature
  46. 46. Overview • Shows a summary of the report – All filled in fields – All fields with errors or warnings – Only to be used for a quick overview not “print or read friendly”! If you are about to finalize/commit a report and it is reporting that it has errors… this is the place where to go!
  47. 47. Reaction lookup tool • The reaction lookup tool has been rebuilt in version 4.1 and further of VigiFlow. New features are: – The lookup is done without leaving the page where the term shall be added – The entire search tree is displayed in the result – Searches can be done with • Begins with, equals and contains – Searches can be done on specific levels – Result tree can be expanded
  48. 48. Reaction lookup tool
  49. 49. Drug lookup tool • With version 4.1 of VigiFlow one of the major changes is the tool to pick drugs from WHO-DD • The aim is to: – Make it easier to find the appropriate drug and drug level – Make it more difficult to suggest new drugs!
  50. 50. Enter a new drug only if you could not find an appropriate drug in the drug lookup tool Select appropriate level depending on available information on report and details available in WHO- DD.
  51. 51. Comment on report entry • VigiFlow contain a large number of data fields, filling them all in may be very time consuming But… • There are only 5 mandatory fields –Header, initials (recently modified), Age at the onset of ADR, drug, reaction and onset date (Year) On the other hand… • More data will improve the overall quality and simplify the causality assessment
  52. 52. VigiFlow – hands on • Form groups of three or four • One in the group must be a ”experienced” VigiFlow user – But – someone else should do the hands on! • Create one ”made up” report with your ”group name” in the report header and a small amount of data – Add at least two reaction • Save and committ the report – Write down the report number • Search for the report in the search and statistics tool and export the result set on excel format
  53. 53. Vigiflow Without Mouse Access Keys to facilitate switching between different pages without pressing mouse. To switch to a specific pages the access keys are Alt + [keys] After opening the report handling page if we want to go directly to drug entry page.. Alt + [6] { Because in the left page menu particular section denoted by a specific number or [Letter].
  54. 54. The access keys for buttom Entry Alt+[c] and Alt+[n] Variability based on Web Browser: For Internet Explore: Alt+[1]+ Enter For Mozilla Fire Fox: Shift + Alt+ [1] Pressing back function in the secure web browser is generally discouraged.
  55. 55. Thank you
  56. 56. Next Discussion will be on Advanced usage of vigiflow