1 Scope
This European Prestandard specifies general messages for electronic informationexchange between computer systems used by healthcare parties prescribing, dispensingor administering medicinal products/medicinal appliancesa). The contentand structure of the messages specified in this European prestandard have beendeveloped with the aim of optimising the safety of prescribing and dispensing and tofacilitate compliance monitoring and secure audit trails.
Whenever medicinal products are mentioned within this European prestandard, medicinalappliances may be substituted if they serve similar purposes and can be representedin similar ways in a message as medicinal products.
This European prestandard is applicable to messages for electronic informationexchange of prescription sets issued (i.e. prescribed) by healthcare persons (andpossibly other persons who on this occasion act as healthcare persons) authorised bynational regulations.
This European prestandard is applicable to messages for electronic informationexchange of prescription sets sent by a prescriber to a dispensing healthcare party(dispensing agent) and to healthcare persons/organisations or official authoritiesas permitted by national regulation. This European prestandard is also applicable tomessages for electronic information exchange of prescription sets sent by theprescriber to a relaying agent and from a relaying agent to a dispensing agent.
NOTE A relaying agent is a special Electronic Message Handling Service from where oneand only one dispensing agent may retrieve any single prescription set; onceonly, upon the request of the party for whom the prescription message is issuedor their agent.
This European prestandard is applicable to messages for electronic informationexchange of prescription sets issued for single human patients, single animals, agroup of animals, for personal use by the prescriber or for use at the prescriber’spremises without specified end user. The categories for which any authorisedprescriber may prescribe are regulated nationally.
This European prestandard specifies a message, new prescription message,for electronic prescribing of medicinal products/medicinal appliances sent from theprescriber to a dispensing agent, possibly via a relaying agent.
This European prestandard specifies messages for retrieval of a new prescriptionmessage temporarily stored by a relaying agent. This European prestandard specifies:
Prescription query message querying if any or specifiedprescription set(s) exist for a single subject of care at a relaying agentmatching a set of selection criteria. This message is sent froma dispensing agent to a relaying agent.
Prescription set list message listing the prescription set(s)(and the contained prescription items) stored at a relaying agent in replyto a prescription query message. This message is sent from a relaying agentto a dispensing agent.
Prescription set selection message for requesting a relayingagent to transmit new prescription message(s) referenced by one or moreprescription set identifier(s). Identifiers are either obtained by aprevious prescription query message/prescription set list message orsupplied by the subject of care or animal carer without a previous query.The message is sent from a dispensing agent to a relaying agent who willrespond by sending the new prescription messages identified by theprescription set selection message.
NOTE The above three messages always handle prescription sets as a whole, asingle prescription item in a prescription set cannot be handledindividually. Locally it may be agreed to allow only one prescriptionitem per prescription set, thus permitting individual handling ofprescription items.
This European prestandard specifies a message, prescription dispensing reportmessage, containing information about prescription items in a prescriptionset as they have actually been dispensed (or not dispensed), normally in response toa new prescription message. This message may be sent from a dispensingagent to the original prescriber and/or to any other party that is legally permittedto receive such message
This European prestandard specifies two messages for cancelling a previously sent newprescription message or prescription dispensing report message:
prescription cancellation messageand
prescription dispensing report cancellation message.
For a number of reasons the end user may decide not to take delivery ofsome of the originally prescribed items. The handling of thesenon-delivered prescription items may require solutions best dealt withlocally.
NOTE Depending on national legislation and available printing facilitiesthe non-delivered part of a retrieved prescription set may be handedover (in paper form) to the subject of care or his/herrepresentative or may be kept by agreement with the subject of careby the dispensing agent for later dispensing or (by local agreement)the dispensing agent may issue a new prescription message containingthe non-delivered part of the prescription set (maintaininginformation about the original prescriber).
This European prestandard is applicable to repeat prescription messages.If permitted locally, new prescription messages containing repeatprescribing of prescription items, whether sent directly to a dispensingagent or via a relaying agent, may only, according to this Europeanprestandard, be transferred to a dispensing agent in their entirety.
NOTE Non-delivered repeat prescribing of prescription items may be dealtwith as non-delivered prescription items in general.
This European prestandard is applicable to the issue of new prescriptionmessages carrying a first date for dispensing. Such messages may be usedaccording to national regulations e.g. in countries where repeatprescribing is not allowed. The mechanisms and rules for checking andreleasing these new prescription messages are outside the scope of thisEuropean prestandard.
When implementing information exchange based upon this Europeanprestandard, data protection and confidentiality principles have to beguaranteed according to the laws actually in force in the different CENmember countries. The mechanisms needed to secure data integrity, dataprotection and confidentiality, authentication of communicating partiesand patients are outside the scope of this European prestandard.
While the messages specified in this European prestandard may conveyclinical and administrative information concerning patients, the way inwhich this information is treated in this European prestandard does notconstrain the development of future standards for the electronichealthcare record or for other clinical and administrative messages.
The provisions of this European prestandard have been validated for thepurposes described above. However, since the messages described in thisEuropean prestandard are designed for general application inprescribing, the users are required to decide for themselves whether ornot these messages meet their particular requirements. A requirement forusing other messages, e.g. generic messages for cancellation oracknowledgement, in addition to or instead of messages specified in thisEuropean prestandard, does not invalidate the use of this Europeanprestandard.
This European prestandard is not applicable to messages related tomedicinal product orders exchanged between pharmacies and medicinalproduct suppliers.