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Target release

W4-Operation Ready

Document status

DONE

Document status date

Jun 29, 2020 12:26

Document author

eHDSI Business Analyst

Source document(s)eP Functional requirements
Page Historyhttps://ec.europa.eu/cefdigital/wiki/pages/viewpreviousversions.action?pageId=84417757

Table of Contents



Functional Requirements (normative)


  • NCPeH of Country of affiliation must make available to NCPeH of Country of treatment at least the basic (or essential) information needed by the HP of Country of treatment to provide safe healthcare.
  • NCPeH of Country of affiliation must provide information about the reason of the missing data for the basic sections of the ePrescription clinical document sent to the NCPeH of Country of treatment.
  • At least the list of all available ePrescriptions must be provided by the NCPeH of Country of affiliation to the NCPeH of Country of treatment. The available ePrescriptions are those that can be dispensed to the patient at the moment of the request.
    • The description of each ePrescription from the provided list must contain the product name/generic substance name, dosage form and strength, in order for the HP to be able to easily identify the ePrescription required by the patient to be dispensed.
    • In case some of the ePrescriptions from the provided list are not available to be dispensed, this fact must be clearly indicated by the NCPeH of Country of affiliation.

ePrescription Content


There are 2 types of data elements identified in the clinical documents exchanged within eHDSI:

  1. Basic data set (Minimum data set): It is a fundamental data set, understood as a set of essential information required by the health professional to provide safe care to a patient, in an unscheduled scenario. The agreed data elements must be sent by each NCPeH, even if there is no content available (exceptional values are allowed).
  2. Extended data set (Maximum data set): The agreed data elements or their values do not have to be sent, the NCPeH has the option to send the data or not, based on the availability of the data sets. 
    • These data elements are considered optional.

The following table presents the sections and data elements agreed to be part of an ePrescription document, together with the description/meaning of each data and some examples. 

  • The data elements are presented in structured data groups, each of them containing related items of information. They are shown taking into account that they are a defined set of key data without any architectural or data modelling consideration.

Info

If a section contained at least one data element of type ''basic'', the section type was set to ''Basic''. Otherwise, the section type was set to ''Extended''.

  • The basic sections are highlighted in green.

The terms ''Prescriber'' and ''Dispenser'' were replaced by the more generic terms of ''HP prescribing the medicine'' and ''HP dispensing the medicine''. Depending on each country's legislation, the HP roles who can prescribe or dispense the ePrescription document might be different.

Data elements description



No.CONCEPTUAL GROUPING
(Level 1)

SECTION*

(LEVEL 2)

*basic sections highlighted in green

BASIC

(= at least one data element is ''Basic'') / EXTENDED SECTION

DATA ELEMENTS

(LEVEL 3)

DESCRIPTION

(Business and Functional meaning)

BASIC/ EXTENDED DATA SETRemarks

1. PATIENT IDENTIFICATION

1Patient IdentificationRegional/National Health IDBASICRegional/National Health IDIf the patient has a regional or national Health Identification. This field is required by some national laws.Basic
2Personal InformationFull NameBASICGiven Name

The first name of the patient. This field can contain more than one element.
The subject's identifying name(s) within the family group or by which the subject is uniquely socially identified [ISO TS 22220].

Example: John, Marta.

Basic
3Family Name/Surname

The surname/s of the patient. This field can contain more than one element.

Example: Español Smith.

The part of a name a person usually has in common with some other members of his/her family, as distinguished from his/her given names [ISO TS 22220].

Basic
4GenderEXTENDEDGender

The gender of the patient. Gender is the biological distinction between male and female [ISO TS 22220]. The gender of the patient may be noted on the prescription since this can be important for gender specific effects of drugs, contra-indications etc.

This field can be empty.

Example: Male, Female.

Extended
5Date of BirthBASICDate of Birth

The date of birth of the patient. Since age affects drug ADMET (absorption, distribution, metabolism, excretion and toxicity) parameters, this is important for the choice of drug and drug dosage.

This field may contain only the year, if day and month are not available.

Example: 01/01/2009.

Basic
6Patient Insurance InformationSocial/Insurance NumberEXTENDEDSocial/Insurance Number

If a patient has both Regional/National Health ID and Social/Insurance Number, only the Regional/National Health ID is required by law.
If the only identification the patient has is the Social/Insurance Number, then this one is considered as the Regional/National Health ID.

This field is required by some national laws.

Extended

2. HEALTH PROFESSIONAL IDENTIFICATION

(HP prescribing the medicine)

7HP IdentificationHP ID NumberBASICHP ID Number

The identification of  the person as health professional (the HP prescribing the medicine to the patient).

A unique number or code issued for the purpose of identifying a health care provider [ISO/TS 27527:2010]; this may be a licence or registration number which can be used to trace the HP and to check whether a drug was prescribed by the right person according to the law.

Example: 12345.

Basic
8HP Personal InformationFull NameBASICGiven NameThe name of the HP prescribing the medicine to the patient. This  field  can  contain  more  than one element.Basic
9Family Name/Surname

The surname/s of the HP prescribing the medicine to the patient. This  field  can  contain  more  than one element.

Example: Español Smith.

Basic
10ProfessionProfession

The profession of the HP prescribing the medicine.

Example: Physician.

Basic
11Medical SpecialtyMedical Specialty

The field of practice/specialization of the HP prescribing the medicine.

Example: Dermatologist.

Extended
12Facility AddressFacility AddressBASICName of the Facility

The name of the place where the HP prescribing the medicine made the prescription.

For instance, the name of the building. Example: Los  Bermejales Health Care Centre. 

Extended

Note: This is not a field, but a block of information made up of the following fields. This might not be in the data set, but this information needs to be available for the process traceability.

The Facility Address defines the place (complete address) where the HP prescribing the medicine made the prescription (where the health professional normally works, meets patients and prescribes medication).

13Street address

The street of the place where the HP prescribing the medicine made the prescription.

Example: Alemania Street.

Extended
14City

The city of the place where the HP prescribing the medicine made the prescription.

Example: Seville

Extended
15Zip or Postal Code

The postal code of the place where the HP prescribing the medicine made the prescription.

Example: 41018

Extended
16State or Province

The province of the place where the HP prescribing the medicine made the prescription.

Example: Seville

Extended
17Country

The country where the prescription was made.

Example: Spain.

Basic
18Telephone

The phone number of the place where the HP prescribing the medicine made the prescription.

Example: +34 954123123

Extended
19E-mail

The contact e-mail of the facility or of the HP prescribing the medicine.

Example: losbermejaleshealthcentre@xxx.es

Extended
20HP OrganizationHealthcare provider organization (HCPO)

EXTENDEDOrganization Name

The name of the healthcare provider organization of the HP prescribing the medicine.

Example: Andalusia Health Service.

ExtendedNote: This is not a field, but a block of information made up of the following fields. This might not be in the data set, but this information needs to be available for the process traceability.
21Organization Identifier

The identification of the healthcare provider organization of the HP prescribing the medicine.

This filed can be numbers and/or letters.

Example: 123458xfs.

Extended

3. PRESCRIPTION CLINICAL DATA

(Identification of the prescribed medicine/medicinal product)

22

PRESCRIPTION IDENTIFICATION

Prescription ID

BASIC
Prescription ID
Identification of the prescription.Basic
23

MEDICINAL PRODUCT DESCRIPTION

Medicinal Product Code

BASIC
Medicinal Product Code

National code that identifies the medicinal product description, in that region/country or among some countries (Country of affiliation cross-border/regional/national Medicinal Product Code).

Some countries like Denmark and Sweden might have the same medicinal product code.

Basic
24

Country of treatment SINGLE CONCEPT

Active Ingredient

Substance that alone or in combination with one or more other ingredients produces the intended activity of a medicinal product.

Country of treatment translates (does not change) the active ingredient from Country of affiliation to Country of treatment units (single concept), but it is the same active ingredient.

Example: Paracetamolo.

Basic

In Art-Decor, the ''Active Ingredient'' element is usually filled in if the ''Active ingredient ID code'' is available, but it can be provided as free text as well.

Note: The ''Single concept'' is not a field, but a block of information made up of the grouped fields under ''Country of treatment Single Concept'' term.

If a single prescription is made in Country of affiliation, in Country of treatment cannot be several prescriptions. It has to be one for practical reasons and then a brand name among all available in Country of treatment should be selected.

It is the translation to a single concept in Country of treatment, from the eHDSI semantic format. This is not a mapping to the existing medicinal products in Country of treatment.

Example: Paracetamolo; 0,5g; 30 tablets (the original medicinal product prescribed in Country of affiliation is Termalgin - in Country of treatment).

25
Strength of the Medicinal Product

The content of the active ingredient expressed quantifiable per dosage unit, per unit of volume or per unit of weight, according to the pharmaceutical dose form.

Strength has the following sub-elements: - Value (100, 200 etc.) - Unit (mg, gr etc.)

Country of treatment translates (does not change) the strength from Country of affiliation to Country of treatment units (single concept), but it must be the same strength.

Example: Dose/unit - 500mg that it is what contains 1 tablet, i.e. the unit  in Country of affiliation, it can be 0,5g in Country of treatment.

BasicFrom technical point of view, the Strength is represented as the ''Quantity'' element.
26
Medicinal Product Package

This is the size of the package prescribed in Country of affiliation.

Example: 30.

Basic
27
Pharmaceutical Dose Form

The form in which a pharmaceutical product is presented in the medicinal product package (e.g. tablets, syrup).

Country of treatment translates the dose form from Country of affiliation to Country of treatment units (single concept), but it must be the same pharmaceutical dose form.

Example: In Country A is ‘comprimidos’ and in Country B ‘tablets’.

Basic
28Brand Name of the Medicinal Product
Brand Name of the Medicinal Product

The name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the marketing authorization holder.

This is a free text field and can be empty if the prescription was made by active ingredient.

Example: Termalgin.

Extended
29

Route of Administration

Route of Administration

Indicates the part of the body through or into which, or the way in which, the medicinal product is intended to be introduced. In some cases a medicinal product can be intended for more than one route and/or method of administration.

Country of treatment translates the route of administration from Country of affiliation to Country of treatment units, but it is the same route.

Example: In injectable: intramuscular. In tablet: oral.

ExtendedNote: Although ‘Route of Administration’ has been considered a maximum data element as it is normally a free text, ePrescription Guidelines is concerned about the importance of this field and the impact of not having it. In some countries, route of administration is already included within the pharmaceutical dose form but if not, the only measure we can provide at this moment is that the dispenser can check a copy of the original prescription to help him/her with this issue among others.
30

Number of packages

Number of packages

Number of boxes that have been prescribed in the Country of affiliation.

Example: 2.

Basic
31

Posology

POSOLOGY

Instruction on number of units per intake, frequency of intakes (per day/month or week) and duration of treatment.

Country of treatment translates the posology from Country of affiliation to Country of treatment units, but it must be the same posology.
This field can be a single field or a block of different fields: Number of units per intake, frequency of intakes (per day/month/week) and duration of treatment.

Example: 1 unit/intake every 24 hrs for a duration of 30 days in country A can be 1unit/intake, once a day, during 1 month.

BasicWhen Posology is a single field, information that should be present in the optional fields, is expected to be present in the single field as free text.
32
Number of units per intake

The number of units for each intake that the patient is taking.

Example: 1 tablet.

ExtendedThis attribute is part of the posology.
33
Frequency of intakes

Frequency of the intakes that the patient should take (per hour/day/month/ week).

Example: Each month.

Extended

This attribute is part of the posology.

34
Duration of treatment

The duration for which the patient should take the medicine.

Example: During 14 days.

Extended

This attribute is part of the posology.

It is constituted of 3 optional subfields: start date, end date, length of treatment. End date and length of treatment are mutually exclusive.

35

Substitution

Substitution

It indicates if a substitution is allowed by the HP in the Country of affiliation, considering patient safety reasons.

Could be presented as a ''Yes/No'' field.

Extended
36Marketing Authorization Holder
Marketing Authorization Holder of the prescribed medicinal product

The name of the company or other legal entity that has the authorization to market a medicine in one, several or all European Union Member States.

This is a free text field and can be omitted if this information is unknown.

Example: AstraZeneca AB

Extended

4. PRESCRIPTION DATA (Information about the Prescription itself)

37Prescription DataDate of issue of the prescriptionBASICDate of issue of the prescriptionDate when the prescription was made.Basic
38Date of onset of treatmentDate of onset of treatmentDate when the patient needs to start taking the prescribed medicine.Extended
39Date of end of treatmentDate of end of treatmentDate when the patient has finish taking the prescribed medicine.Extended
40Instructions to patientInstructions to patient

The instructions that the HP prescribing the medicine might give to the patient. They must be presented in the original language.

Example: Take only when headache.

Extended
41Advise to the dispenserAdvise to the dispenser

The instructions that the HP prescribing the medicine might give to the HP dispensing the medicine.
The   information   will   be   in   the original language as automatic translation is not secure enough. To avoid legal and ethical issues to the dispenser, it should be wise to implement an option that allows the dispenser to decide, knowing that this data is available, whether s/he wants to consult it or not.

Example: Watch hypertension.

Extended

2 Comments

  1. It should be clarified what is meant by basic/extended data set and by mandatory (yes/no). Is there a relation between these two?

    My suggestion would be to remove the basic/extended separation completely and concentrate on defining cardinalities of elements.

    1. Sorry, Konstantin HYPPÖNEN, but the status of this functional requirement should not have been ''Ready for review''. Indeed, the relation between the basic/extended and mandatory characteristic of the data set will be explained. The cardinality is considered technical information and can now be found in Art-Decor. 

      I couldn't remove the basic/extended separation, as it was defined in the previous Functional Requirements document. We can still discuss and draft a CP if needed to remove this information. Thank you.