Improvements and clarifications eP cross-border Annika Ohlson, Oskar Thunman 2018-03-19

Summary In the pharmaceutical and technical workgroup we are discussing findings from the implementation in wave 1. We have to decide whether this findings will affect the functional requirements or if it is most suitable to add as information. The easiest thing is to add to existing documents. We have the functional requirements, the Implementation Guide and the communication document that includes both general information and specific information to pharmacists about prerequisties both general and national. In this document we have summarized valuable information from our dicussions that we suggest will be complemented in either the Implementation Guide and/or the communication document as information for pharmacists. We have also separated possible changes in the functional requirements with suggestion that we decide what change proposals we would like to create.

Communication document general information and specific information to pharmacists about prerequisities both general and national ”Split” Implementation Guides In ART-DECOR Together with STF

General considerations Clarify in the functional requirements that all information about the product in the eD must reflect information about the dispensed product and information from the prescription about the product should not automatically go into the eD. Include this even in the Implementation Guide and information to pharmacists. Does this need a change proposal?

ATC code The functional requirements states that the ATC code may not be changed when substituting the product (nor when substitution does not take place). How should we handle that the product has different ATC codes in different countries?

Brand name Suggestion to add “MAH” to help Country B identify the product. The guidelines on ePrescription should consider “MAH” as an optional element for the next release. The functional requirements and implementation guides should be modified accordingly. Clarify in the functional requirements that the brand name may differ slightly between the eP and the eD even when the same product was dispensed due to products being marketed under different names in different countries. Add the information to Implementation Guide and information to pharmacists as well.

Change proposal Add a new field for “MAH” to help Country B identify the product.

Pharmaceutical dose form Pharmaceutical dose form should not be modified, regardless of the value of the substitution code. This is a hard rule, but necessary as a starting point. In the future, a hierarchy of dose forms should be established so simple things like ”film coated tablet  ”tablet” is equivalent and possible to dispense. Note that the work with IDMP is ongoing and that will be the solution in the future.

Strength and active ingredients Can we say something about the order of the strengths in the “epsos desc” element? In the information to pharmacists explain that for medicinal products containing several active ingredients information about strength could be both structured and in free text and that the order could be differing between those. Clarify in the Implementation Guide that all pharmaceutical products must have an ingredient identified although this can be achieved in a few different ways.

Change proposals Does the functional requirements need additional clarifications?

Package type Clarify in the functional requirements that changing the package type is not considered a substitution. Add the information to Implementation Guide and information to pharmacists as well. Does this need a change proposal?

Package size and number of packages Suggestion to add to the functional requirements that the size of the package size in the eD should be expressed using the same unit as in the eP to allow country A to calculate the total amount dispensed. Suggestion to add to the functional requirement that the package size multiplied with the number of packages should amount to the total amount dispensed to the patient. Clarify in the Implementation Guide that packages with packaging multipliers that have an inner package expressed in volume or weight should make use of the “number of packages” element to capture the package multipliers. Describe in the information to pharmacists that if the unit is filled in manually by the pharmacist they have to use this principle. Example: if 2x10x0.35ml is dispensed 20x0.35ml should be the package size/number to be transmitted in the pivot.

Package size and number of packages Suggestion to add to the functional requirements that the number of packages must be an integer and that if fractions of packages are dispensed this should be reflected through the package size. Make the package size in the Implementation Guide an integer. Include this information to pharmacists as well. Clarify in the functional requirements that changing the package size is not considered a substitution. Does this need a change proposal? Suggestion for future improvements: add new field for package size multiplier, maybe this has to be considered together with other changes towards IDMP-harmonization. add new fields for number of refills and total amount. Requires national and cross-border “rules” for partial dispensation to be clearly defined.

Change proposals Add to the functional requirements that the size of the package size in the eD should be expressed using the same unit as in the eP to allow country A to calculate the total amount dispensed. Is a change proposal needed? Clarify in the functional requirements that changing the package size is not considered a substitution. Is a change proposal needed? Add new field for package size multiplier. Add new fields for number of refills and total amount.

Agenda F2F meeting This meeting will be focused on pharmaceutical and semantic aspects. There will also be a technical bootcamp two weeks later that will have to take care of the technical parts. In the sessions before lunch the organisation and work is presented as a platform for the discussions in the afternoon. Especially the information to citizens, health care professionals and pharmacists is important to be aware of as a complement to functional specifications and the Implementation Guide. In the afternoon we have the chance to present what eP wave 1 has done and learned. We suggest that we summarize what has been added (several active ingredients) and the preparatory work in the eP-group including these issues and a brief summary of functional testing to be able to decide on necessary actions and future cooperation.

Thank you