Electronic prescription and the implementation of the ePrescription information system are based in legislation – Act No 378/2007 Coll., on Pharmaceuticals, as amended. The doctor issues an electronic prescription (ePrescription) for the patient and on the basis of the ePrescription, the pharmacy dispenses the medicinal product. The Central Repository of Electronic Prescriptions (“CÚER”), as one of the components of the ePrescription system, collects and stores all ePrescriptions under conditions stipulated by effective legislation. The implemented ePrescription system is one of the provided eHealth services and its operation in the Czech Republic has been mandatory since 1 January 2018. Section 81f of Act No 378/2007 Coll., on Pharmaceuticals, permits certain exceptional situations in which it is still possible to issue paper prescriptions.
With regard to the requirement of mandatory electronic prescription, the process of modernization of the entire system started as early as in 2015, reflecting its incorporation into eHealth – the National Electronic Healthcare Strategy and the eGovernment Development Strategic Framework 2014+. The implementation of the ePrescription project followed its valid schedule and the project was completed in December 2017. The ePrescription system was included in the critical infrastructure of the state, and hence has been subject to the tightest security measures as referred to under the Act on Cybersecurity and related legal regulations.
Since 1 January 2018, the system has been operated in the mode of mandatory electronic prescription and has been running smoothly. Health insurance companies routinely download batches of ePrescriptions of their insureds, which gives them a complete overview of expenses. Since the start of the mandatory electronic prescription, applications for the doctor, patient, and pharmacist have been also made available. In their application, doctors can prescribe an ePrescription outside their office. The patient application allows patients to display a list of all of the ePrescriptions issued for them, in respect of which citizen identification in the Registry of Inhabitants (“ROB”) was performed. In their web application, the patients may also decline the possibility of healthcare professionals viewing the patient’s medication list. The application for pharmacists allows pharmacists to obtain information about the medicines prescribed on the ePrescription in case standard communication with the ePrescription system fails.
The ePrescription system has already brought many a benefit, particularly for the patient. Although the patient still has the option to obtain the identifier in the form of a printout accompanying document, which is the most frequently used option, electronic delivery of the ePrescription identifier – particularly by means of an SMS or e-mail message – keeps gaining popularity. In 2018, 3 million such SMS messages and 492 thousand e-mail messages were delivered in total; in 2019, it was more than 10.5 million SMS messages and 702.5 thousand e-mail messages; in 2020, these numbers further increased to nearly 28.5 million SMS messages and 840 thousand e-mail messages. In 2021, there were already over 31 million SMS and 687 thousand email messages.
In 2018, 58.5 million electronic prescriptions in total were issued and the total amount of reimbursements for dispensed reimbursed medicinal products prescribed via the ePrescription system was more than 26,118,000 thousand CZK.
In 2019, more than 73.5 million electronic prescriptions were issued, 71.5 million electronic prescriptions were dispensed, and the total amount of reimbursement for dispensed reimbursed medicinal products prescribed via the ePrescription system exceeded 33,154,301 thousand CZK, which is more than a 25% increase. The record day of the year was Monday, 16 December 2019, when more than 445.5 thousand electronic prescriptions were prescribed.
In 2020, more than 79 million electronic prescriptions were dispensed and almost 77 million dispensed; the total amount of reimbursement for dispensed reimbursed medicinal products prescribed via the ePrescription system was more than 32,981,849 thousand CZK, which only confirms the routine usage and availability of the system from previous years. This may be even further evidenced by the break of the jubilee 200-million mark in the number of ePrescriptions issued since January 2018, when the mandatory ePrescription started. The record day of the year was Monday, 6 January 2020, when more than 620 thousand ePrescriptions were prescribed.
In 2021, more than 76 million electronic prescriptions were issued, almost 75 million electronic prescriptions were dispensed. The record day was 1 November 2021 when more than 433 thousand prescriptions were prescribed. Another jubilee 300 million limit of the number of ePrescriptions issued since January 2018, when the mandatory ePrescription was launched.
Almost 50 thousand doctors and dentists have access data generated by SÚKL, which is an absolute majority. Both in 2019 and in 2020, verification of applications was routinely conducted in all professional chambers. Prescribed medicinal products may be dispensed in practically all pharmacies in the Czech Republic. As of 31 December 2020, 45,763 doctors, 18,247 healthcare facilities, and 2,875 pharmacies were actively involved. These numbers suggest a stable and routine usage of the ePrescription system by the absolute majority of healthcare service providers and healthcare professionals.
System support is provided on an ongoing basis and the system is being continuously upgraded and modernised, taking into account suggestions received both from professionals and from the general public. One of the major changes implemented in 2019 was the change of the medium used for the primary identifier where the bar code was replaced with a QR code. This change had been planned in the long term in order to improve the quality of identifier scanning in pharmacies (QR codes are more tamper resistant).
Furthermore, in mid-2019, SÚKL rolled out a back-up system (third data centre). The purpose of the back-up system is to support a smooth dispensing of electronic prescriptions within the territory of the Czech Republic in case of a sudden outage of the primary ePrescription system that provides for this service. The back-up section of the ePrescription information system is totally independent of the primary one and it is operated in a completely separate location.
On 1 January 2020, the Ministry of Labour and Social Affairs and the Czech Social Security Administration (ČSSZ) rolled out an electronic sick note system. For authentication in the B2B channel, the same certificate is used as the one used by the healthcare service provider (healthcare facility) for SSL communication with the ePrescription system. In October 2019, electronic sick note testing commenced, and SÚKL provided maximum cooperation in the implementation of the ČSSZ project. This is an important step for healthcare professionals, as they may avail of their existing authentication tools in another system that has been implemented nationwide by public administration.
The adoption of amended Act No 378/2007 Coll., on Pharmaceuticals, that took effect on 1 December 2019, followed by the publication of a new Decree No 329/2019 Coll., on the prescribing of medicinal products that took effect on 1 January 2020, brought a number of changes associated with electronic prescriptions.
The most awaited one was the change allowing to share the patient´s medication list, which is, in essence, a list of all electronic prescriptions issued or dispensed for an unequivocally identified patient. Medication list may be displayed only for those patients whose identity has been unequivocally established against ROB in the process of prescribing the medicinal product. Following a thorough consideration of the situation in the Czech Republic and with a view to the actual benefits and practical aspects of the patient´s medication list so called opt-out system was selected. This means that unless the patient expresses his/her disagreement with the viewing, the doctor, pharmacist or clinical pharmacist may view the patient´s medication list The logging of all declined or granted consents is safeguarded by the ePrescription consent administration that was put into live operation on 1 December 2019. At any time, the patient has the right to express their general disagreement with doctors or pharmacists viewing his/her medication record. Equally, the patient may grant an express consent for a selected specific doctor or pharmacist.
Patients can express their dis/agreements via the patient web application, patient’s data mailbox or a letter signed with an officially authenticated signature.
The procedure to be followed if a healthcare professional wishes to view the patient´s shared medication list has been also precisely defined by legislation. Pursuant to the effective legislative provisions, the first viewing of the patient´s medical list by a doctor who has not prescribed any ePrescription for the patient to date, shall be possible only upon the submission of the patient´s ID card. Where, however, the link between the doctor and the patient is evidenced by the fact that the doctor previously issued an ePrescription for the patient which was subsequently dispensed, submission of the ID card is not necessary. A pharmacist may view the list only upon submission of the ID card or during the dispensing of a valid (dispensable) ePrescription.
The same rules as those for adult patients apply also to minors.
Dis/agreements of minors may be expressed via the patient web application of the minor patient´s legal guardian, or a letter signed with an officially authenticated signature of the minor patient´s legal guardian.
The viewing of the patient´s medication list proper has been possible since June 2020. Along with the roll-out of the shared medication list, it is also possible to avail of a check of duplicities in medicinal product prescribing.
Another adjustment to the ePrescription system was done with regard to the newly established reimbursement of medical cannabis from the public health insurance system. As of 1 January 2020, the ePrescription system has been providing support in the recording of the amounts of dispensed medical cannabis in the amount of 30 g with a 90% reimbursement from the public health insurance system. This change was associated with a complete change of the prescription codes for cannabis, recording of both maximum dispensing limits (the existing maximum for dispensing of 180 g per month and the new maximum amount of cannabis with 90% reimbursement of the price from the health insurance system), as well as a change of services for pharmacists who, when dispensing cannabis, must distinguish whether they dispense reimbursed or non-reimbursed cannabis.
A substantial change implied by effective and valid legislation is the obligation to digitize paper prescriptions in the pharmacy. This is a completely new functionality and, for the purposes of digitized prescription record-keeping (electronic dispensing records), it was necessary to prepare new services for pharmacists and health insurance companies who obtain information about digitized prescriptions for the purposes of establishing reimbursement of these activities for the pharmacies.
The legislation also implied minor changes that had to be reflected in the system by 1 January 2020. Such changes include, for instance, cancellation of two-item prescriptions for paper prescriptions as of 1 June 2020 (checks during digitalization), unification of prescription validity to 14 days, and adding a patient contact on the ePrescription at the time of illness (telephone or address of residence). Furthermore, web and mobile applications were amended to meet the currently effective legislative requirements.
In addition to the legislative changes, a new functionality of sharing important information about medicinal products was established as of 1 January 2020. This facilitates better information provision for doctors, pharmacists as well as patients. Using the ePrescription system, it is possible to display information regarding the prescribed or dispensed medicinal product. This includes, in particular, education materials, DHPC or other important information.
Since 1 April 2020, Czech citizens also may request an excerpt of electronic prescriptions issued and dispensed for them within a selected period of time from the ePrescription information system at a public administration contact point (Czech POINT). Thanks to this functionality, the patient may have his/her electronic prescriptions printed out at the Czech POINT branch; the scope of the data provided is defined by governing legislation.
As of 1 June 2020, the patient also has a new option to hand over a list of all of his/her ePrescription identifiers in the pharmacy by means of submitting a machine-readable identification document – primarily the citizen´s ID card. On the basis of the submitted patient´s ID card, the pharmacist may obtain a list of all ePrescriptions that should be dispensed to the patient in question. The dispensing of the medicinal products proper is then carried out as usual, on the basis of the obtained ePrescription identifiers.
The electronic prescription has proven much useful particularly at the time of the COVID-19 epidemics in the Czech Republic. In this difficult period, the electronic prescription supported the required social distancing in a highly effective manner, significantly reducing the necessity for patients to visit their doctors in the offices, remarkably contributing to the protection of the health of all Czech citizens.
Based on the amendment to Act No. 167/1998 Coll., on Addictive Substances and Amendments to Some Other Acts, so-called ePrescriptions with a blue stripe were introduced. The effective date was set for 1 January 2022. This involves the issuance of prescriptions for medicinal products containing highly addictive substances listed in Annex No. 1 or 5 of the Government Regulation on the List of Addictive Substances. Record keeping of electronic recipes with a blue stripe is mandatory.
On the basis of Act No. 89/2021 Coll., on Medical Devices, with an impact on Act No. 378/2007 Coll., on Pharmaceuticals, effective from 26 May 2021, the launch of electronic prescription of medical devices was established. For the computerization of vouchers, the effectiveness was "floating", in accordance with Communication No. 54/2022 Coll., on the commissioning of the central repository of electronic vouchers, dated 8 March 2022, electronic prescription of medical devices was launched from 1 May 2022 in an optional mode. This is the introduction of computerization of vouchers for medical devices . Computerization applies to all types of vouchers, so it is possible to prescribe eprescription to all medical devices that have been prescribed in paper form so far. The prescriber issues the electronic voucher similarly to the eRecept, so there is no big change for the prescriber in this respect. Electronic vouchers for medical devices are stored in the central repository of electronic vouchers.
Based on the amendment to Act No. 167/1998 Coll., on Addictive Substances and its impact on Act No. 378/2007 Coll., on Pharmaceuticals, which came into effect on 8 October 2021, the central repository of vaccination records becomes part of the eRecept system. Registration of vaccination records in the eRecept system is mandatory. The recording of vaccinations carried out concerns all types of vaccination, i.e. regular, special, extraordinary, voluntary, reimbursed and non-reimbursed. Since December 2021, the patient has the right to express disagreement with the viewing of vaccination data similarly to the patient’s medication list, and since 1 January 2022, electronic records of vaccination have been successfully deployed in production operation, for which the The Ministry of Health has set an exception for the so-called no penalty period for a period of 6 months from the date of introduction of this new service. Information about the applied vaccination of the patient is available in the patient's medication list. The medication list will thus allow patients, doctors and pharmacists to view the data on the vaccination carried out.
At the same time, SUKL has long been involved in the project "Deployment of Cross Border Services in the Czech Republic - NIX-ZD.CZ II. (ePrescription/eDispensation)", the primary objective of which is to extend electronic dispensation beyond the borders of the Czech Republic to other EU countries. The recognition of prescriptions issued in another EU Member State is already introduced by Directive 2011/24/EU on the application of patients' rights in cross-border healthcare. At present, therefore, there is an electronization of health care (eHealth) in the EU Member States, including in the field of electronic prescribing. The NIX-ZD.CZ II project focuses on the cross-border exchange of ePrescriptions and information on dispensed medicines, as a result of which the safety and quality of health care provided and patient comfort will be increased. Currently, the expected date of the Czech Republic's involvement among other countries participating in cross-border data exchange is the beginning of 2023.