Final 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). In order for this to be achieved, a  common understanding of the ePrescription service within the epSOS Large Scale Pilot (LSP) framework had to be agreed upon and Use Cases defined. 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, another goal was also to identify desirable processes that would improve the service but which might be difficult to implement in this LSP for all MS.

The discussion and the content regarding this deliverable starts with the concepts, ideas and descriptions contained in the previous deliverable, D3.1.1 ‘Draft definition of functional service requirements - ePrescription’ with input from WP 2.1 ‘Analysis and comparison of legal and regulatory issues’. While D3.1.1 was focused on the analysis of the ePrescription service, identifying possible alternatives and issues, this deliverable, D3.1.2 ‘Final definition of functional service requirements - ePrescription’ describes the service based on the preferred solution or alternative, applies the solutions of the issues that have been solved and sets out conclusions and issues that will be encountered during the pilot phase.

The major business decision agreed upon after the development of the draft deliverable is that prescriptions, as orders, must be the responsibility of the country that generates them. This means that at this stage, any prescription written in a foreign country will not be sent to the patient’s home country to be managed as an order in that country. This decision is based on the yet immature European framework regarding the ePrescription service, including legislation or processes, as reflected in the issues identified in this document.

The two Use Cases identified, Use Case 1 ‘Medicine already prescribed in Country A’ and Use Case 2 ‘Medicine newly prescribed in Country B’, have been carefully analysed and all possible issues and requirements have been identified. Also, potential exceptions to the processes are explained and an assistance service is described. Use Case 1 has been described in more detail and prioritised because of  a higher perceived benefit to the patient while Use Case 2 has been considered as an experimental Use Case that will not be implemented in this LSP (see Annex I of D3.1.2).

The main issue that affects Use Case 1 - namely medicine already prescribed in Country A being dispensed in Country B - is the potential problem associated with semantics. Prescriptions are issued in different ways in different European countries, leading to concerns around patient safety in ensuring that the right information and medicine is received. Other important issues are related to the different processes and concepts for ePrescription in all countries. Therefore the way in which the European service is defined must be as transparent and neutral as possible to these processes and concepts. Last but not least, legislation represents a potential major challenge to the dispensing of a prescription across borders. The legislation pertaining to the country in which the prescription is written may be very different to that across a border. Suggestions are included as to how the validity of a prescription can be identified as it crosses borders and how these challenges might be addressed.

Other important issues that affect both Use Cases are those related to patient identification, patient consent, the management of data, which originated in another country, and how to include the data in systems whilst complying with the relevant legislation.

The functional requirements identified to fulfil the Use Cases are:

• 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)
• transparency of a country’s processes (including legislation) to the other countries.

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

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

A classification of the various information datasets, which have been identified, was 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 items: the dispenser can safely dispense, even if this information is not received, and once the medicine has been dispensed, the related prescription can still be identified and updated. If a country has additional information, it can make it available to another country to use in the dispensation process (i.e. the fields exist and make sense in that other country).

The main recommendations for the other WPs (excluding those derived from the functional requirements that affect other WPs such as Semantics, Identification or Security) are:

• the semantic transformation of the medicine based on the active ingredient and not on brand name
• the need for contractual agreements to create a secure legal framework
• it is essential that during the pilot phase, any exceptions, either functional or technical are clearly reported, analysed and a procedure needs to be put in place in order to evaluate and to solve them (change management). Every person involved in the process need to be informed of the services, their rights and duties.

In summary, although currently most of the issues identified are also raised when patients travel abroad with paper prescriptions, the epSOS LSP should overcome these barriers by taking advantage of the technologies to improve the services available to cross-border patients.

However, action at the European level is also needed:

• to prevent current legal restrictions from seriously jeopardising the ePrescription services and hence the benefits to patients in their countries
• to ensure patient safety by avoiding issues like substitution of brand names due to the differences between medicines across Europe. Not only is a common medicinal nomenclature or language needed but also a common criteria for the semantic description of different medicinal elements, which is maintained and updated at a European level.