Draft definition of functional service requirements - ePrescription

Based on the principles stated in the foreword, the goal of this deliverable was to identify the requirements that, from the viewpoint of the Health Care Professional (HCP), are necessary in order to implement a feasible ePrescription service; especially with respect to the level of maturity of the solutions in a member state (MS). Prerequisite for this was to have reached agreement on the common understanding of the ePrescription service within the epSOS Large Scale Pilot (LSP) framework and a determination of the Use Cases. In consequence, the aim was to focus on those requirements strictly necessary to achieve a minimum but secure and safe service, always considering patient safety as paramount. At the same time, the goal was also to identify desirable requirements that would improve the service but which might be difficult to implement in this LSP for all MS. Another goal of the document, as stated in Annex I, is to describe the possible alternatives regarding the services.

The discussion and the content concerning this deliverable was initiated by concepts, ideas and recommendations from WP 1.1 ‘Analysis and comparison of national plans/solutions’ in which the solutions of the different countries are analyzed, and from WP 5.2.1 ‘Initial Scope’, in which the initial scope regarding the Use Cases as well as a number of initial issues need to be addressed by this WP. The document intends to simplify the services, by avoiding already existing complex matters (from the functional and legal perspective) in the different MS. The functional requirements identified should ensure:

• the security of the service, including identification, authentication or patient consent access to the information from/to another country
• the correct interpretation of the information (semantics, correct identification of the medicine,…)
• provision of the minimum information needed to fulfil all steps of the service (prescribe, dispense and inform on the dispense)

Non-functional requirements have been identified in addition to functional requirements, as they are not only needed to fulfil the functional ones but are directly related to the HCP experience and to the security of the process.

During the analysis of the Use Cases, two main alternatives were identified regarding the provision of the services. One is the Single or Unified Source of Information (SSI), which assigns the responsibility of offering the interoperability services to the country where the patient can be univocally identified. The second alternative is the Multiple or Distributed Source of Information (MSI), which distributes the responsibility of the interoperability services among all countries where relevant patient information (identified in this deliverable) has been generated (i.e. every country is responsible for the information that it generates). All pros and cons have also been analysed (see section 5.2.4).

The entire ePrescription service has been analyzed regarding the different sets of information needed for the exchange of the services - from the country where the information is generated to the country, which receives this information and semantically processes it. The datasets described in the deliverable reflect the information of the country where it is needed and after its semantic processing.

A classification of the various information datasets, which have been identified, were developed based on their degree of relevance:

• Minimum or essential data for the dispenser, which is considered essential from the pharmaceutical point of view in order to identify the medicine or to make sure if it is legally required, and to update the related prescription once the medicine has been dispensed.
• Maximum or additional data offering information, which is not mandatory but facilitates other services like pharmaceutical care. It is therefore  recommended to provide them to the MS in which these services are implemented.

A set of issues and recommendations for other WPs has been identified during the entire process.

Important issues include the correct identification of the medical product prescribed in the country where it will be dispensed, as this may vary among the different countries (brand name, package size,…), and in consequence, ‘the substitution’ of the original medical product prescribed.

Furthermore, the different meaning of  ‘available’, ‘current’ or ‘valid’ prescriptions; or issues regarding the different legislation valid in different countries applying  to medical products, or when prescribing or dispensing. This deliverable includes a set of open questions regarding some of the above-mentioned issues that need to be answered by WP 2.1 ‘Legal and regulatory issues’. These answers will in turn be included in the final deliverable for this WP (see section 8.3).

The main recommendations, apart from those derived from the functional requirements and which affect other WPs, such as Semantics, Identification or Security, concern the following: semantic transformation of the medicine based on the active ingredient and not on the brand name and the minimum content of the medication summary  (list of current prescriptions).

Finally, it is essential during the pilot phase that any exceptions, whether functional or technical, must be clearly described and analysed. Furthermore, a procedure must be put in place to evaluate and resolve these exceptions.