Decree No. 329 / 2019 Coll.
Decree on the prescription of medicinal products for the provision of health services
Valid
Order
Effective from 01.01.2020
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329
DECLARATION
of 5 December 2019
on the prescription of medicinal products for the provision of health services
According to Article 114 (1) of Act No. 378 / 2007 Coll., on medicinal products and on amendments to certain related laws (Act No. 262 / 2019 Coll., as amended by Act No. 375 / 2011 Coll., Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll. and Act No. 262 / 2019 Coll., to implement § 80 (5) (a) to (d) and (f) to (i), § 81 (4) (a) and (b), § 81a (1) and (4) and § 81e (6) of the Act on medicinal products:
Preliminary provisions
This decree provides
(a) the procedure and conditions for obtaining access data and certificates for communication with eRecept;
(b) the procedure and conditions for communicating doctors and pharmacists with the eRecept system;
(c) the form of the electronic recipe identifier provided by eRecept to prescribers and patients;
(d) the extent and duration of the data needed for the creation, modification and cancellation of the electronic recipe;
(e) the method of sending requests for the creation, modification and cancellation of an electronic recipe by the prescribing physician;
(f) the extent of the contact details of the doctor and pharmacist processed by the Institute through the eRecept system;
(g) the extent of data on the verified output from the eRecept system;
(h) the procedure for expressing or withdrawing the opposition and granting or withdrawing the consent of the patient to consult the data provided for in Section 81d (3) of the Medicines Act and the method of managing the records;
(i) the extent of the data on the paper-based recipe and its duration;
(j) rules on the use of the recipe in paper form;
(k) the scope of the data referred to in the request, its period of validity and the rules governing its use;
(l) the extent of the data needed to create, modify and delete the vaccination record;
(m) the extent of the information given in the extract of the vaccination carried out and its form;
(n) the model of the blue stripe recipe, which is displayed in paper form, and the model of the blue stripe demand, which is displayed in paper form,
(o) the particulars given on the blue-striped recipe, which shall appear in paper form, its period of validity and the rules governing its use;
(p) data to be provided on requests with a blue stripe, which is displayed in paper form, its period of validity and the rules governing its use;
(q) the rules and method of distribution, record keeping, return and disposal of recipes and blue stripe requests.
Procedure and conditions for obtaining access data and certificates
(1) Upon request, the Institute will issue access data pursuant to Section 81a (1) of the Drug Act
(a) a doctor who is entitled to prescribe medicinal products under the drug law,
(b) a contract doctor prescribing medicinal products to himself, his spouse or partner, his parents, grandparents, children, grandchildren and siblings under the Public Health Insurance Act (1);
(c) to a pharmacist,
(d) to an authorised health insurance worker,
(e) to an authorised staff member of the Ministry of Health,
(f) to an authorised official of the Police of the Czech Republic.
(2) The person referred to in paragraph 1 (a) to (c) shall obtain access data from the Institute pursuant to Section 81a (1) of the Medicines Act upon request by means of an electronic form published on the Institute's website.
(3) The person referred to in paragraph 1 (d) to (f) shall obtain access data from the Institute under Section 81a (1) of the Drug Act upon written request
(a) the relevant health insurance undertaking in the case of a person referred to in paragraph 1 (d);
(b) the Ministry of Health for the person referred to in paragraph 1 (e);
(c) Police of the Czech Republic in the case of a person referred to in paragraph 1 (f).
(4) Each natural person may have at the same time only one access data. Access data shall be non-transferable and may only be used by the natural person issued. The release of new access data is only possible if the previously issued access data is deleted.
(5) The person referred to in paragraph 1 (a) to (c) makes use of his access data obtained under paragraph 2 in the course of his or her profession, including in the case of the pursuit of the profession of several health service providers at the same time. The access data obtained shall not be altered in the event of a change of the employer or in the case of a change of the data contained in the application on the basis of which, according to the first sentence, the person has received the access data.
(6) The person referred to in paragraph 1 (d) to (f) may only use his access data obtained under paragraph 3 as a worker of the entity which applied for his access data. In case of changes to the data contained in the application on the basis of which the person obtained the access data, the access data shall not be changed.
(7) Upon request, the Institute will issue a health service provider, health insurance company, the Ministry of Health and the Police of the Czech Republic an access certificate pursuant to Section 81a (1) of the Drug Act for secure communication with the eRecept system; the application for the issue of an access certificate shall be sent by means of an electronic form published on the Institute's website.
(8) The Institute shall revoke the access data of the person referred to in paragraph 1:
(a) in the event of the death of the person who issued the access data;
(b) in the case of the issue of new access data at the request of the person concerned,
(c) where access data are suspected of being misused or compromised,
(d) at the request of the person who requested the release of the access data.
Procedure and conditions for communication with eRecept
(1) Communication between the eRecept system and doctors or pharmacists takes place via the eRecept data interface and the information system used by doctors or pharmacists, with the communication channel encrypted.
(2) Communication between eRecept and doctors or pharmacists also takes place directly through the eRecept web or mobile application pursuant to § 81 (1) (f) of the Drug Act, with the communication channel encrypted.
(3) Data sent to eRecept are generated by a doctor or pharmacist and sent to eRecept in the form of structured data. The technical requirements for the format of structured data are set out in the eRecept operating documentation.
(4) Data sent pursuant to paragraph 3 must be signed by a recognised electronic signature in accordance with the legislation governing trust services for electronic transact2). This procedure does not apply when a doctor or pharmacist accedes to the eRecept system through the National Identification and Authentication Point.
(5) The Institute, in accordance with Section 81 (2) of the Drug Act, creates and publishes on its website the eRecept operating documentation. 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 the eRecept system;
(d) the specification of access security and data transfer between the information system used by the prescribing physician or the issuing pharmacist and the eRecept system; and
(e) other technical specifications necessary for the operation of eRecept.
Electronic recipe identifier
The electronic recipe identifier is generated by the eRecept system in an alphanumeric form of a character identifier that is convertible into a two-dimensional or one-dimensional barcode.
Scope of the data needed to create the electronic recipe and its details
(1) The request for an electronic recipe shall state:
(a) the period of validity of the electronic recipe;
(b) the way in which an electronic recipe identifier is delivered to the patient; If the method of sending the identifier is chosen via eRecept by text message or by e-mail, the request shall also include the telephone number or e-mail address to which the identifier is to be delivered,
(c) symptom
1. "Recurrent recipe," indicating the total number of dispenses, in the case of an electronic prescription containing the prescribed medicinal product, the dispensation of which is to be repeated (the "repetitive recipe"); the repeated supply cannot be used for medicinal products containing an addictive substance under the legislation governing the treatment of addiction3), for medicinal products marked "restricted availability 'under Section 33b of the Drug Law or for medicinal products containing a category 1 substance under the directly applicable European Union drug precursor regulation 4),
2. "emergency care," where a medicinal product is prescribed for the public health insurance account by non-contracting medicine5) within the framework of the emergency care provided by it,
3. "emergency," if it is a prescription issued by a medical emergency or dental emergency,
4. "ad sum proprium" or "for the needs of the family" in the case of a medical requirement referred to in § 2 (1) (b),
5. "highly addictive substance," if it is a recipe for a substance-containing medicinal product listed in Annex 1 or 5 to the Government Regulation on substance-containing lists, which are not listed in Annex 8 to the Government Regulation on substance-containing substances,
(d) the number of the approved application for approval and the amount of the approved refund where the payment of one of the prescribed medicinal products is linked to the approval of the revised medical practitioner of the relevant health insurance undertaking.
(2) In relation to the patient to whom the medicinal product is prescribed, the
(a) the indication of the patient's health insurance by a code number if the medicinal product is to be covered by public health insurance (5), or a sign that the reimbursement of the medicinal product results from an international agreement or other legislation6),
(b) the name and, where appropriate, the name, surname and address of the patient's permanent residence and, if he is not resident, the address of the patient's residence;
(c) the patient's telephone number, if it is not available, the address of the patient's whereabouts;
(d) the number of insured persons (5), if allocated; if the insured person's number has not been assigned to the patient or if the insured person's number cannot be determined by his age, the date of birth of the patient,
(e) if the patient is under 7 years of age, the doctor shall indicate his weight in kg if this is not adequate for his age;
(f) the address of the detention prison to which the person has been taken if he / she is a person in custody;
(g) the address of the detention centre or detention centre to which the person was placed, if he / she is a person in the execution of a prison sentence or security detention; and
(h) patient identifier 19).
(3) The requirement in relation to the prescribed medicinal product should include:
(a) identification of the medicinal product
1. the code assigned by the Institute under which the medicinal product is authorised or allocated to it;
2. the protected name under which the medicinal product was authorised (7), the pharmaceutical form, the strength and the packaging size; or
3. the international non-proprietary name of the active substance recommended by the World Health Organisation, indicating the required dosage form, strength and quantity of the required dosage form,
(b) in the case of a preparation medicinal product, its identification by a pharmacopoeia or its synonym or abbreviation mentioned in the Czech Pharmacopoeia (8) or by the name of a medicinal or auxiliary substance included in the list provided for by other legislation9) or by the name of the substance for which authorisation has been granted by the Ministry of Health under the Law on Medicines, including for its individual components, with the required quantity in grams, where another unit is used, that unit shall be indicated;
(c) the main diagnosis related to the prescribed medicinal product if an increased remuneration is requested by the prescribing physician or a highly innovative or individually prepared cannabis-containing medicinal product for therapeutic use is prescribed, in the form of a numerical diagnosis according to the International Statistical Classification List of Diseases and Associated Health Problems;
(d) the number of packages or doses; in the case of prescription of a medicinal product for public health insurance, the electronic recipe may contain more than one package of one type of medicinal product to ensure that the patient is treated until his next visit to the treating physician, but for a maximum period of 3 months,
(e) instructions for the use of the medicinal product;
(f) the method of reimbursement of the medicinal product by stating the words:
1. "payable by the patient," if the medicinal product is not to be covered by public health insurance (5), or if the prescriber does not have a contract with the patient's health insurance (5), unless it is urgent care,
2. "basic payment," if the medicinal product is to be covered by public health insurance,
3. "increased payment," if required by the prescribing physician for a medicinal product which has it under another legislation5),
4. "paid by the patient's employer,"
5. "basic remuneration with an employer's supplement," or
6. "increased remuneration with an employer's supplement,"
(g) symptom
1. "do not confuse," if the prescribing physician insists on issuing the prescribed medicinal product,
2. "excess" if there is a deliberate excess of dosage established by the Czech Pharmacopoe8) or the dosage or indication given in the Summary of Product Characteristics (10),
3. "Unregistered LP," if it is about the prescription of an unauthorised medicinal product.
(4) In relation to prescribers and health service providers, the requirement shall include:
(a) identification of the health service provider to the extent
1. the name and, where applicable, the surname of the doctor, the address including the telephone number, the place of provision of the health services, the name of the workplace and the identification number allocated by the health insurance company, if the health insurance company is a natural person; or
2. name or business name, registered office including telephone number, place of provision of health services, place of work name and identification number assigned by the health insurance undertaking, if the health insurance company is to conclude a contract, if it is a legal person;
(b) the name and, where applicable, the name of the prescriber, and the surname of the prescriber, if the health care has been provided to a health service provider who is a legal person or who is a natural person in business;
(c) the name and, where appropriate, the name, surname, address of the place of residence, including the telephone number of the prescribing doctor, if it is the doctor referred to in § 2 (1) (b).
(5) In the case of a requirement to create an electronic prescription for a medicinal product whose payment from public health insurance is limited from the point of view of the professional prescriber (5) and which is issued by a doctor of other expertise, the requirement shall also include the name and, where applicable, the names, surnames, identification number assigned by the health insurance company and the expertise of the doctor who recommended the prescription of the medicinal product; the doctor's recommendation must be based on the patient 's medical documentation at the latest on the day of prescription of the medicinal product.
(6) The requirement to create an electronic recipe must not contain more than 2 types of medicinal products. The requirement to create an electronic prescription for a substance-containing medicinal product listed in Annex 1 or Annex 5 to the Government Regulation on substance-containing lists which are not listed in Annex 8 to the Government Regulation on substances-containing medicinal products shall not contain more than one type of medicinal product.
(7) The requirement to create a repetitive recipe may contain 2 types of medicinal products only if the number of repetitions for both medicinal products is the same.
Method of sending requirements for creating an electronic recipe
(1) The requirement to create an electronic recipe is sent by the prescribing doctor of the eRecept system, indicating the data referred to in § 5, in accordance with § 3.
(2) After receiving the data set necessary to create the electronic recipe, the eRecipe system will create an electronic recipe and assign an electronic recipe identifier.
(3) The eRecept system sends a confirmation of the creation, processing and storage of an electronic recipe to the prescriber through its information system, web or mobile application. The certificate sent shall include the identifier assigned to the electronic recipe referred to in paragraph 2 and the information on whether the patient has been successfully identified against the population register.
Change of the electronic recipe
(1) For the purpose of correcting the data on the electronic recipe, the prescriber may make a change to the electronic recipe stored in the eRecept system for which the eRecept system has been confirmed to have been created, unless an eRecept system has been sent to a record of the dispensing of the medicinal product, the initiation of preparation or the start of dispensing of the medicinal product, or the period of validity of the electronic recipe has elapsed.
(2) The requirement to amend the electronic recipe is sent by the prescriber of the eRecept system, indicating the electronic recipe identifier to which the change relates and the data that is changed; in the case of a change concerning a prescribed medicinal product, information on the implementation of the change shall be included. In the event of a change concerning a prescribed medicinal product for which the patient has not been informed by the prescriber, the physician shall state the reasons for the need of the issuing pharmacist. After creating an electronic recipe, it is not possible to change the identification of the prescriber, the health service provider and the date of its issue in the electronic recipe.
(3) The eRecept system will store and return information on the change of the electronic recipe data to the prescriber through his information system, web or mobile application, to a confirmation that the required change of the electronic recipe has been made.
Repeal of the electronic recipe
(1) The electronic recipe created in eRecept may be cancelled by the prescribing physician if new facts are found unknown at the time of the prescription or if structured data are missent to the eRecept system for the purpose of creating an electronic recipe, unless the eRecept system has been sent a record of the dispensing of the medicinal product, the initiation of preparation and the start of the output or the duration of validity of the electronic recipe has expired.
(2) The request for cancellation of the electronic recipe is sent by the prescriber of the eRecept system with the identifier of the electronic recipe that is being cancelled.
(3) The electronic recipe for which the cancellation request has been sent will be labelled as cancelled by the eRecept system and cannot be delivered at the pharmacy.
(4) The eRecept system will send the prescriber through its information system, web or mobile application a confirmation of the cancellation of the electronic recipe.
Duration of the electronic recipe
(1) The electronic recipe is valid for 14 calendar days starting on the day following its issue, unless otherwise specified by the prescribing physician, but not more than 1 year.
(2) The electronic recipe, which contains the flag "highly addictive substance," is valid for 14 calendar days starting on the day following its issue, unless otherwise specified by the prescribing physician, but not more than 30 calendar days.
(3) The electronic recipe, which contains the symbol "repetitive recipe," is valid for 6 months from the day after the day of its issue, unless otherwise specified by the prescribing physician, but not more than 1 year.
(4) The electronic recipe which contains the "Urgent Care" flag referred to in Section 5 (1) (c) (2) or the "Emergency" flag referred to in Section 5 (1) (c) (3) shall be valid until the end of the first day following its issue.
(5) If the prescribed number of packages of the medicinal product is not available at the pharmacy and cannot be obtained promptly, the pharmacist may extend the period of validity of the electronic recipe by up to 14 calendar days, on the basis of a request sent to the eRecipe system.
Data processed through eRecept
The Institute processes the contact details of the prescribing doctor and dispensing pharmacist through the eRecept system
(a) the identifier of the data box if the data box is established;
(b) delivery address,
(c) a telephone number,
(d) e-mail address.
Verified eRecept output
(1) When requesting the issuance of a certified eRecept output, the patient should select in the case of a certified output containing data relating to each
(a) to a patient prescribed an electronic recipe or an electronic voucher which has been created in a patient of the chosen period, the period for which he requests to create a verified output, indicating the date, month and year of the beginning and end of that period, and whether the validated output should contain only data on electronic recipes, only on electronic vouchers, or both; the validated eRecept system output also contains data from recipes exposed to the patient in paper form, which have been transferred to electronic storage in the patient's chosen period (11); or
(b) a record of the vaccination of a patient who was created in the patient's chosen period, the period for which he requires the verified output to be created, indicating the date, month and year of the beginning and end of that period.
(2) The verified eRecept output referred to in paragraph 1 (a) contains:
(a) the name and, where appropriate, the name, surname and date of birth of the patient;
(b) the selected period during which the verified output was created;
(c) details of the electronic recipe and the electronic record to the extent
1. the date of creation, the identifier, the flag referred to in Article 5 (1) (c) and the number of repetitions in case it is a repetitive recipe;
2. the name and, where applicable, the name of the prescriber, the name of the health service provider;
3. the name, type, pharmaceutical form, strength, package size, amount and instructions for use of the prescribed medicinal product,
4. an indication of whether the electronic recipe has already been delivered or if the electronic recipe has been cancelled,
5. the date of issue of the prescribed medicinal product, the name and address of the pharmacy where the medicinal product was delivered, the quantity of the medicinal product delivered and its name, if different from that prescribed,
(d) electronic voucher details to the extent
1. date of creation and identifier,
2. the name and, where applicable, the name of the prescriber, the name of the health service provider;
3. the code, name, group, type and quantity and, where applicable, other information relating to the group of prescribed medical devices;
4. an indication of whether the electronic voucher has already been issued or if the electronic voucher has been cancelled,
5. the date of issue of the prescribed medical device, the name and address of the dispenser at which the dispenser was issued, the quantity of medical device issued and its name, if different from the prescribed medical device.
(3) The verified eRecept output referred to in paragraph 1 (b) contains:
(a) the name and, where appropriate, the name, surname and date of birth of the patient, the insured person's number, if allocated, and the number and type of electronically readable patient identification documents;
(b) the selected period during which the verified output was created;
(c) a unique alphanumeric indication of the vaccination record and the date of its creation;
(d) the name and, where applicable, the names of the doctor and the identification of the health service provider;
(e) the name of the applied human immunological medicinal product, including the indication of the disease against which the product is intended, the lot and the order of the dose applied,
(f) the date of application of the immunological medicinal product for human use and, where appropriate, the scheduled date of administration of the following dose, if applicable, if it is a multi-dose immunological medicinal product for human use.
Consent management
(1) The patient may object to the consultation of data displayed through his drug record, or to a previously expressed disagreement
(a) through a web application service for patients,
(b) a notification sent through the patient's data box or the legal representative's data box, if the patient is a minor child, to the Institute's data box; or
(c) by sending a letter of formal signature to the address of the seat of the Institute.
(2) A model for submission containing a statement of opposition pursuant to paragraph 1 (b) and (c) shall be published by the Institute on its website.
(3) A patient who has expressed opposition to the consultation of data displayed through his drug record may agree to the consultation of data displayed through his drug record by means of a web application service for patients, provided that:
(a) the doctor to whom the patient wishes to give individual consent has already issued an electronic prescription to the patient;
(b) a pharmacist to whom the patient wishes to give individual consent has already given the medicine to the patient on the prescribed electronic prescription.
Scope of data needed to create a vaccination record
In the requirement to create a record of vaccination in the register of the current health status of natural persons who have become ill with infectious diseases and of natural persons suspected of being infected under the Public Health Protection Act (17), in the context of the application of a human immunological medicinal product:
(a) in relation to the patient, the departmental identifier of the patient; If there is a patient who is not registered in the basic population register under the Basic Registers Act 18), please indicate:
1. name, if any, and surname,
2. date of birth,
3. the number of the insured person, if assigned,
4. citizenship,
5.
6. type and identification document number,
(b) in relation to vaccination carried out:
1. the identification data of the health service provider to the extent of the identification number of the person, the code of the medical establishment and the workplace identification number, if assigned by the health insurance undertaking,
2. the name or code of the applied human immunological product allocated by the Institute; the batch number or expiration date, if known at the time of application of the immunological medicinal product,
3. Date of vaccination,
4. the health insurance code or the indication that it is a self-payee;
5. an indication of the type of vaccination, whether it is primary vaccination or re-vaccination; in the case of primary vaccination, indicate the order of the dose of vaccination applied; and
6. in the case of a patient, e-mail address and telephone number for the public mobile telephone network, if the patient has communicated them; or
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Regulation Information
| Citation | Decree No. 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.12.2019 |
|---|---|
| Effective from | 01.01.2020 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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