Decree No. 415 / 2017 Coll.
Ordonnance for the implementation of certain provisions of the drug law concerning electronic recipes
Valid
Order
Effective from 01.01.2018
Text versions:
01.01.2018
07.12.2017
415
DECLARATION
of 30 November 2017
to implement certain provisions of the Act on medicines related to electronic recipes
The Ministry of Health, after consulting the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior and the Ministry of Justice, pursuant to § 114 paragraphs 2 and 3 of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), for the implementation of § 80 paragraphs 1 and 2 of this Act, as amended by Act No. 70 / 2013 Coll. and Act No. 66 / 2017 Coll.:
This decree regulates
(a) the way in which the identifiers provided by the central repository of electronic recipes are created for prescribers;
(b) the procedure and conditions for communication by prescribing physicians and pharmacists issuing prescribed medicinal products (hereinafter referred to as "the issuing pharmacist") with a central repository of electronic recipes;
(c) the way in which electronic recipes are sent by doctors;
(d) the method of recording electronic recipes;
(e) situations in which the issue of a prescription in paper form is always permitted;
(f) the method of handling recipes which have been presented in paper form.
Method of creating identifiers
The electronic recipe identifier ("identifier ') is generated by a central repository of electronic recipes, in an alphanumeric form of a character identifier that is transferable to the form of a one-dimensional barcode or a two-dimensional code.
Procedure and conditions for communication by prescribing physicians and pharmacists issuing prescribed medicinal products with a central repository of electronic recipes
(1) Communication between the central repository of electronic recipes and prescribers and issuing pharmacists is carried out through the communication interface between the information system of the central repository of electronic recipes and the information system of prescribing doctors and issuing pharmacists.
(2) The prescribing physician and the issuing pharmacist communicate with the central repository of electronic recipes based on access data in a secure way, with the communication channel being encrypted. The prescribing doctor and the issuing pharmacist shall access the central repository of the electronic recipes through their access data and the SSL certificate of the health service provider's health service provider for which they conduct their profession.
(3) The prescribing physician shall have access in the central repository of electronic recipes by means of an identifier to the electronic recipes which:
(a) issued through its information system and stored their identifiers; or
(b) have been prescribed by other doctors and their identifiers have been transmitted to them;
whether or not medicinal products have been issued on their basis.
(4) The issuing pharmacist shall have access to the electronic recipes in the central repository by means of an identifier provided by the patient.
(5) The central repository of electronic recipes will confirm receipt and storage of the data sent by the prescribing physician and the issuing pharmacist.
(6) The State Institute for Drug Control publishes and publishes on its website operational documentation for electronic prescription and dispensing of medicinal products. This documentation shall include:
(a) specification of the interface format, including definition schemes for document validation;
(b) the specification of identifiers, including their format and technical parameters for their interpretation;
(c) a detailed technical description of the communication of the prescribing physician and the issuing pharmacist with a central repository of electronic recipes;
(d) the specification of access security and data transfer between the information system of the prescribing physician or the issuing pharmacist and the central repository of electronic recipes;
(e) other necessary technical specifications for the operation of the central repository of electronic recipes.
(1) The prescriber shall obtain access data from the central repository of electronic recipes pursuant to Article 3 (1) on the basis of a request sent by means of an electronic form published on the website of the State Institute for Drug Control, upon request.
(a) their persons; or
(b) his employer.
(2) The issuing pharmacist shall obtain access data from the central repository of electronic recipes in accordance with Article 3 (1) on the basis of its request by means of an electronic form published on the website of the State Institute for Drug Control.
(3) Where the prescribing physician and the issuing pharmacist have obtained their access data pursuant to paragraph 1 or 2, they shall also use them in the course of their profession for several health service providers.
(4) The access data already obtained by the prescribing physician and the issuing pharmacist shall not be changed even if:
(a) change its employer; or
(b) the data contained in the request on the basis of which it received the access data will be changed.
(1) Data sent to the central repository of electronic recipes are generated by the prescribing physician and the issuing pharmacist and sent to the central repository of electronic recipes in the form of structured data.
(2) The data referred to in paragraph 1 must be signed by a recognised electronic signature under the legislation governing trust services for electronic transact1).
(3) The central repository of electronic recipes shall, upon receipt of the data set for the establishment of the electronic recipe, assign an identifier to the established electronic recipe.
(4) The central repository of electronic recipes will send a certificate to the doctor's information system on the establishment, processing and storage of the electronic recipe. The identifier assigned to the electronic recipe referred to in paragraph 3 shall be part of the certificate sent.
(5) Communication and data transmitted between the prescribing physician, the issuing pharmacist and the central repository of electronic recipes are recorded in the records of entries and activities of the central repository of electronic recipes. This record shall be recorded in the case of:
(a) sending a request for the establishment of an electronic recipe for its acceptance, including the data sent, identification of the prescriber, date and time of receipt of the request;
(b) the dispatch of data from the central repository of electronic recipes of the identification of the prescribing physician or the issuing pharmacist, the data sent, the date and time of dispatch of the data.
(6) In the context of the requirement to establish an electronic recipe, the prescribing physician shall indicate the form of communication of the identifier to the patient chosen in accordance with paragraph 8 (b) to (d).
(7) In the prescriber's information system, identifiers are stored for the established electronic recipe for the possibility of a later access of the prescriber to the electronic recipe in the central repository of electronic recipes for 5 years.
(8) The prescriber's electronic recipe identifier shall be communicated free of charge to the patient, at the choice of the patient.
(a) by means of a paper guide generated using the information system of the central repository of electronic recipes and the information system of the prescribing doctor;
(b) in the form of a data message sent to the address of the patient's e-mail using the information system of the central repository of electronic recipes,
(c) in the form of a text message sent to the patient's mobile telephone device using the information system of the central repository of electronic recipes,
(d) by means of a data message using a web or mobile application made available by the State Institute for Drug Control;
(e) in the form of a data message sent to the patient's e-mail address using the doctor's information system; or
(f) in the form of a text message sent to the patient's mobile telephone device using the information system service of the prescribing doctor.
(9) The identifier shall be transmitted to the patient in accordance with paragraph 8 in such a form as to be easily legible to the naked eye.
Restricted medicinal products
(1) In order to ensure compliance with the restrictions laid down in the marketing authorisation for a medicinal product, prescribing physician shall communicate with the medicinal product registry with the restriction via the central repository of the electronic recipes and its access data.
(2) If the conditions for prescribing a restricted medicinal product are met, the prescribing physician may send a request for the establishment of an electronic recipe containing a restricted medicinal product.
Replacement means of communication
(1) In the absence of communication from the issuing pharmacist with the central repository of electronic recipes due to a failure of services providing the activity of the communication interface of the information system of the issuing pharmacist with the central repository, a alternative means of communication may be used through:
(a) telephone services where information on the contents of the electronic recipe can be provided after the identification and verification of the authorised access of the issuing pharmacist through its access data to the central repository of electronic recipes and the identification of the electronic recipe; or
(b) web or mobile applications created and published free of charge by the State Institute for Drug Control.
(2) The telephone service referred to in paragraph 1 (a) shall be operated by the State Institute for Drug Control and shall be made public on its website.
(3) The replacement communication referred to in paragraph 1 shall be monitored and recorded by the central repository of electronic recipes.
Change of the electronic recipe
(1) For the purpose of correcting the data in the electronic recipe, the prescriber may make a change to the electronic recipe sent to the central repository of the electronic recipe for which acceptance by the central repository of the electronic recipe has been confirmed, unless a record of the dispensing of the medicinal product has been sent to the central repository of the electronic recipe, the initiation of preparation or the start of dispensing of the medicinal product, or the period of validity of the electronic recipe has expired.
(2) The requirement to change the electronic recipe is sent by the prescribing doctor to the central repository of the electronic recipes with the above-mentioned electronic recipe identifier to which the change relates and by the indication to which it is changed. After issuing the electronic recipe, it is not possible to change the identification of the doctor, the health service provider and its date of issue in the electronic recipe.
(3) The information on the change of the data of the electronic recipe shall be stored and sent by return to the doctor's information system a confirmation of the change of the electronic recipe.
Repeal of the electronic recipe
(1) An electronic recipe registered by a central repository of electronic recipes may be cancelled by the prescribing physician in the event of the detection of new facts unknown at the time of the prescription and in the event of incorrect sending of structured data for the purpose of creating an electronic recipe into the central repository of electronic recipes, unless a record of the dispensation of the medicinal product has been sent to the central repository, of the initiation of preparation and of the start of the output or of the duration of validity of the electronic recipe.
(2) The request for the cancellation of the electronic recipe is sent by the prescribing doctor to the central repository of the electronic recipes with the identifier of the electronic recipe that is being cancelled.
(3) The deleted electronic recipe will indicate the central repository of electronic recipes as being cancelled and it is not possible to perform the dispensing at the pharmacy.
(4) The central repository of electronic recipes will send a confirmation to the doctor's information system that the electronic recipe has been cancelled.
Method of recording electronic recipes
(1) Electronic recipes are registered by the central repository of electronic recipes, including information on their establishment, modification and cancellation. Information is also reported that the prescribed medicinal product has been issued for the electronic recipe.
(2) The electronic recipes on the basis of which the medicinal product has been delivered and the particulars contained therein are further recorded in the information system of the issuing pharmacist.
Situations where exposure to a prescription in paper form is permitted
(1) Issue of a prescription in paper form is always permitted when prescribing medicinal products in the framework of the provision of health services in the case of:
(a) recipes for medicinal products containing narcotic substances or psychotropic substances, marked with a blue stripe, the model of which is laid down by the legislation regulating the prescriptionof medicinal products2), with the exception of those for prescription of medicinal products with a restriction pursuant to § 39 (4) (c) of the Law on Medicines and Cannabis for therapeutic use;
(b) request (2); or
(c) prescriptions for medicinal products covered under Article 17 (7) (a) of the Public Health Insurance Act issued by a contract doctor providing medical services to himself, his husband, his parents, grandparents, children, grandchildren and siblings.
(2) In paper form, it is always permissible to issue a request form and a prescription for medicinal products for human use prescribed by the veterinarian when providing veterinary care.
(3) In paper form, it is always permissible to issue a prescription for the medicinal product prescribed in the clinical trial.
(4) In the case of exposure to the paper recipe referred to in paragraphs 2 and 3, the prescribing physician shall always indicate on the recipe the reason for which such a prescription was issued in paper form.
(1) The issue of a prescription in paper form is always permitted when prescribing medicinal products for human use to a prescription, which is issued at the request of a patient and intended for use in another Member State of the European Union.
(2) The prescribing physician shall always indicate on the prescription referred to in paragraph 1 that the prescription has been issued in paper form because of its application in another Member State of the European Union.
(1) Issue of a prescription in paper form is always permitted when prescribing medicinal products in the framework of the provision of health services in:
(a) medical emergency services activities provided under the Health Rescue Service Act (3);
(b) the provision of professional first aid; or
(c) the provision of healthcare in the patient's own social environment (4) if the patient's health status requires the prescription of a medicinal product.
(2) Issue of a prescription in paper form is always permitted when prescribing medicinal products for human use in the framework of the provision of health services in a situation where it is not possible for demonstrable objective technical reasons to issue a prescription in electronic form and the patient's medical condition requires the prescription of the medicinal product.
(3) The technical reason referred to in paragraph 2 is, in particular, a failure
(a) electricity;
(b) Internet operator services,
(c) an information system prescribing a doctor for whom it is not possible to issue an electronic prescription; or
(d) web interface services for a central repository for which it is not possible to issue an electronic recipe.
(4) In the case of the issue of a prescription in paper form in accordance with paragraphs 1 to 3, the prescriber shall always state the reason for which such prescription has been issued in paper form.
Method of handling the prescriptions issued in paper form under Section 80 (1) of the Drug Act
The recipe presented in paper form shall be kept in a pharmacy in accordance with the legislation governing the treatment of medicine5).
Efficacy
This Decision shall enter into force on 1 January 2018.
Minister:
JUDr.
(1) Regulation No 910 / 2014 of the European Parliament and of the Council on electronic identification and trust services for electronic transactions (eIDAS Regulation). Act No. 297 / 2016 Coll., on Trust Services for Electronic Transactions, as amended by Act No. 183 / 2017 Coll.
2) Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the particulars on the prescription and the rules of use of the prescription, as amended.
3) Act No. 374 / 2011 Coll., on Medical Rescue Service, as amended.
4) Paragraph 10 of Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Law on Health Services), as amended.
5) Decree No. 84 / 2008 Coll., on the correct practice of pharmaceuticals, closer treatment conditions for medicinal products in pharmacies, medical devices and for other operators and devices issuing medicinal products, as amended by Decree No. 254 / 2013 Coll.
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Regulation Information
| Citation | Decree No. 415 / 2017 Coll., to implement certain provisions of the Act on Medicines concerning Electronic Recipes |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 07.12.2017 |
|---|---|
| Effective from | 01.01.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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