Pharm Plan Minutes 2018.10.18

Minutes

Attendees

• Leonidas Tzimis
• Marc Robberecht
• Jacqueline Surugue
• Stephane Spahni
• Jurrian van der Werf
• Naomi Jesserun
• Esther Peelen
• Jose Costa Teixeira
• Michael Tan

• Planning of F2F in Vienna in 2019 will be difficult because Juergen cannot attend.
• Review 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.
  • See chart Michael
  • 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 report the care provider will not only report the suspected drug, but they put in the decursus. At the moment they have to look into 2 places. The decursus ( which is free text) and the adverse events reports.

• • Yellow card is for drugs, white card is for devices.
• Status of FHIR resource
• set the scope of of the workitem involving and aligning domains of PCC and QRPH. Michael will report in the DCC call. Action Michael

11:00- 12:30 Adverse Event Reporting

• Not only 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.
• 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.
• Michael to send the Dutch information to Marc.
• Jose will ask in Portugal if there is additional requirements
• 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.
• Create a common cloud for the material in Sharepoint. Action Michael

• Define work items and next steps.
• Work on Technical Supplement
• ICSR has been reconfirmed in 2017 ( ISO standard)

14:00 - 15:30 Medication Information Sharing

This includes the IDMP, Medication knowledge and supporting HL7 resources. Question form International Board to think about IDMP. Understanding the influence of IDMP. Presentation from Christian Hay about IDMP.

QUESTION: Difference between GSRS and DCI.

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

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17:00 - Adjourn

Pharmacy Technical Committee