Pharm Plan Minutes 2018.10.18

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  • Leonidas Tzimis
  • Marc Robberecht
  • Jacqueline Surugue
  • Stephane Spahni
  • Jurrian van der Werf
  • Naomi Jesserun
  • Esther Peelen
  • Jose Costa Teixeira
  • Michael Tan
  • Christian Hay ( partly)
  • Michael van der Zel (partly)
  • Planning of F2F in Vienna in 2019 will be difficult because Juergen cannot attend.
  • Explore possibilities of organizing the meeting on February 25 2019 in Rotterdam. Action Michael.

9:00 -10:30 Adverse Event Reporting

  • NWI planning en schedule
  • Use case and input.
    • File:Workflow.pdf
    • Are patients anonimous: Not in Greece. Drug is also identified.
    • Lareb uses pseudonym between hospital and National body.
    • Patients also have the possibility to report adverse events directly to the regional or national body.
    • This also could be directed through the hospital or primary care.
  • Some figures from Netherlands: spontaneous reporting (10.000) and the reporting in the care process.(1000).
    • in the latter you can collect data which is already registered in the process.
  • Discussion at the HL7 WGM of the starting point of the ADR. It could be just an incident. At a certain point a drug is suspected.
  • In our profile we would start where suspicion is focussed on a drug.
  • In the definition of Lareb the ADR is defined when a care provider intervenes in the drug therapy.
  • Hospitals want to collect all adverse events, not only for pharmacovigilance, but also for knowledge of the drug. Examples are off label drugs. Medication errors must also be reported. Studies show a 20% chance of medication errors. These should also be reported to the regional or national bodies.
  • Lareb obnly collects the ADER, not the medication errors. In the Netherlands these are collected by a seperate institute. Medication Errors are a process error. ADR are not.
  • Lareb passes all messages that are not ADER on to the relevant organizations.
  • In the current situation a care provider usually reports the adverse event 2 places:
    • decursus ( free text in a resume of treamtment)
    • adverse events screens.
  • Yellow card is for drugs, a white card is for devices.
  • The FHIR resource for Adverse Drug Events has a low maturity level. The resource itself looks usable for our purpose.
  • Fix the scope of the workitem and align with the domains of PCC and QRPH. Michael will report in the DCC call. Action Michael

10:30-11:00 Coffee break

11:00- 12:30 Adverse Event Reporting

  • Not only new unknown ADR should be reported, but all ADR should be reported. This gives more insight in real figures of side effects of drugs. This is also in case of drug interactions.
  • Our team will start with the basic reporting.
  • Batchnumber is not always available and is therefore optional.
  • Action now is a comparison of the various requirements from each country:
    • Netherlands
    • Belgium
    • Greece
    • Switzerland
    • France
    • Germany.
  • Marc will make a spreadsheet with the different country specific information. Action Marc
  • Michael will send the Dutch information to Marc. Action Michael
  • Jose will ask in Portugal if there are additional requirements. Action Jose
  • Create a common cloud for the material in Sharepoint. Action Michael
  • Next steps:
    • Define work items and next steps.
    • Work on Technical Supplement
  • ICSR has been reconfirmed in 2017 ( ISO standard)
  • Haemovigilance is not part of the responsibility of LAREB. In the Netherlands we have a seperate institution for haemovigilance.
  • Lareb does distribute the information to other organizations.

12:30 - 13:00 --- Lunch ---

13:00 - 14:00 --- Tour in the Woods

14:00 - 15:30 Medication Information Sharing

Christian Hay presents the progress on IDMP. File:Presentation IDMP.pdf

  • Question from International Board to think about IDMP.
  • Understanding the influence of IDMP.
  • QUESTION:Difference between GSRS and DCI.

15:30 - 15:45 --- Coffee break ---

15:45 - 17:00 Supply topics

Status update The project has not been active. We should finalize the Whitepaper and publish the Whitepaper. Action Jose

  • The next question is which parties are willing to pick up this project and invest time and resources..
  • We should think of parties like IT vendors, but also of suppliers who could benefit from a IHE profile.
  • A connectathon should be of added value for these parties.
  • Jose and Esther will explore interested parties. Examples are Deventer zkn, UMCG. Action Jose, Esther

17:00 - Adjourn

Pharmacy Technical Committee