HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-12-13

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

December 13, 2010


Norman Gregory (CVM), Mead Walker (Health Data & Interoperability Consulting), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller(Alpharma), Jennifer Rice (Alpharma), and Art Griesser (Promethues)

  • www.accessdata.fda.gov is a web server and we have to work with OIM to obtain FTP accounts to load data onto it.
  • The validation web site is up and running at http://estability.prometheuscomputing.com. There was a message "Apologize for the the inconvenience, validation engine down", but it is working now.
  • Added a comment to the section "Current CPM Technical Corrections" at http://wiki.hl7.org/index.php?title=Common_Product_Model regarding substance. The comment is as follows: "Stability reporting has been identified as a POCP_DM010000UV stakeholder whose reporting needs were to be explored. While attending the Fall 2010 Working Group Meeting, the stake holders of Drug Stability Reporting were not heard due to time limitations. We are noting our exception to the model in it current form because it does not address the notion of substance as it is understood in stability testing. The model is focus on how the product presents itself to the patient as an administered product. This in turn makes the substance an administered substance. This does not correlate to stability testing, where the substance (Active Pharmaceutical Ingredient) is a manufactured material, which is similar to a product. There are, however differences between a substance and product that precludes using the Product ProductKind when dealing with substances. Please refer to the Stability Study RMIM. Notice that the message has a choice to report on a substance or a product. Nowhere in POCP_DM010000UV is this choice available. The choice determines the use of other elements and attributes. Most importantly a substance will be an instance of an ingredientManufacturedMaterial with a lot number, existence time and a retest time. We do not think you adequately model the Substance as a ManufactureMateial."
  • If we have too we can change the names in the eStability model in the next release to "StabilitySubstance" and "StabilityProduct".
  • We discussed the e-mail that was posted to the eStability list server at HL7 from Mead Walker about the issues with changes. Issue#1) Core schemas have changed over time, "ClassCode" was not required during pilot (2 years ago), now it is. Moving to Datatypes Release 2 (R2). Issue#2) The names of the artifacts have changed. Numeric extensions appear at the end of the names. (e.g., PORT_IN090004UV (has the information) and PORT_IN090004UV01(empty)). Once normative ballot has passed there should be a number extension at the end,, this did not happen in our case. Mead is talking with HL7 (Don Lloyd) to find out what is happening. Issue#3) Elements in the schema changed their names. Elements that took their name from classes in the RMIMs now appear to take their names from the text appearing next to associations, participations, or act relationships leading to the class. It should not change till the next version. the designer program decides the name, the modeler can change the names of the green, yellow and red boxes.
  • See the attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6059/7899/HL7DrugStabilityReportingValidationProcedures12-13-10.doc) for the eStability Validation Procedures document with changes.
  • There will be no teleconference on December 27.

Agenda for December 20, 2010 Teleconference:

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
  • Schematron progress update
  • Discuss the HL7 issues with Mead Walker (send Mead reminder e-mail)
  • eStability Validation Procedures document

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