Electronic prescription and the establishment of the ePrescription information system are legislatively enshrined in Act No 378/2007 Coll., on Pharmaceuticals, as amended. The doctor issues an electronic prescription (ePrescription) for the patient using the ePrescription system 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 established ePrescription system is one of the services provided within the scope of eHealth and its operation in the Czech Republic has been mandatory since 1 January 2018. Section 81f of Act No 378/2007 Coll., on Pharmaceuticals allows for certain exceptional situations in which it is still possible to issue hard-copy prescriptions.
With regard to the requirement for mandatory electronic prescriptions, as early as in 2015, the process of modernisation of the entire system taking into account also incorporation into eHealth – National Strategy for Electronic Health and Strategic Framework for eGovernment Development 2014+ – has been initiated. The implementation of the ePrescription project followed the predefined schedule and the project was completed in December 2017. The ePrescription system has been included under critical state infrastructure, and for this reason it has been subjected to the tightest security measures referred to under the Act on Cyber Security and related legal regulations. As of 1 January 2018, the system has been operated in the mode of mandatory electronic prescription and has been working without major problems. Health insurance companies routinely download batches of ePrescriptions of their insureds, and hence gain a complete dispensing overview. From the time the mandatory electronic prescription was launched, applications for the doctor, the patient, and the pharmacist have been available as well. In their application, the doctors may prescribe an ePrescription outside their office. The patient application allows the patient to view the list of all ePrescriptions issued for him/her, in respect of which a complete identification of the citizen in the Registry of Inhabitants (“ROB”) was performed. The application for the pharmacist allows the pharmacist to obtain information about an ePrescription in case the standard communication with the ePrescription system is not working.
Even now, the ePrescription system brings a wealth of benefits, particularly for the patient. Although there is still the option for the patient to obtain the identifier in the form of a hard-copy request form and this option is the most frequently utilised one, electronic delivery of the ePrescription identifier – via an SMS or e-mail message – is getting more and more popular. The final annual balance for 2018 accounted for 3 million SMS messages and 492 thousand e-mail messages; in 2019 it was more than 10.5 million SMS messages and 702.5 thousand e-mail messages.
In 2018, the total of 58.5 million ePrescriptions were issued and 56 million dispensed; the total amount of reimbursement for the dispensed reimbursed medicinal products prescribed via the ePrescription system amounted to more than 26 118 000 thousand CZK.
In 2019, more than 73,5 million ePrescriptions in total were issued; 71.5 million ePrescriptions were dispensed, and the total amount of reimbursement for the dispensed reimbursed medicinal products prescribed via the ePrescription system amounted to more than 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 ePrescriptions were prescribed.
Almost 50 thousand doctors and dentists, which is a vast majority, had access data generated by SÚKL. In 2019, in all professional chambers, verification of requests was carried out on an ongoing basis. The prescribed medicinal products may be dispensed practically in all pharmacies in the Czech Republic. As at 31 December 2019, 45 230 doctors, 18 251 healthcare facilities, and 2 873 pharmacies were actively involved.
The system support is ongoing and the system is continuously being enhanced on the basis of suggestions received from professionals as well as from the general public. One of the major changes implemented in 2019 is the change of the primary identifier carrier from barcode to QR code. This change was planned in the long term with the objective to improve the quality of identifier scanning in pharmacies (QR code is less prone to being compromised).
Furthermore, in mid-2019, SÚKL launched a back-up system (third data centre). The purpose of the back-up system is to support a flawless functioning of electronic prescription dispensing within the territory of the Czech Republic in case of a sudden outage of the primary ePrescription system that safeguards this functionality. The back-up part of the ePrescription information system is completely independent of the primary ePrescription system and is run at a completely separate location.
On 1 January 2020, the Ministry of Labour and Social Affairs and the Czech Social Security Administration (CSSA) launched an electronic sick note system. The same certificate as for SSL communication used by the healthcare service provider (healthcare facility) for communication with the ePrescription system is used for authentication in the B2B channel. In October 2019, the testing of electronic sick notes began and SÚKL provided maximum cooperation in the implementation of the CSSA project. For healthcare professionals, it is an important step, as they may use the existing means of authentication for another system that is being implemented nationwide by state administration.
The adoption of the amended Act No 378/2007 Coll. on Pharmaceuticals that took effect on 1 December 2019, and thereafter the issue of new Decree No 329/2019 Coll. on the prescribing of medicinal products that took effect on 1 January 2020, brought many a change relevant to electronic prescription.
The most expected change is the sharing of the patient´s medication record, which is basically a registry of all ePrescriptions issued or dispensed for the identified patient. Only the medication record of a patient whose identity was unequivocally established against the ROB registry in the process of prescribing may be viewed. Following a careful assessment of the situation in the Czech Republic and having regard to the actual benefits and practicality of the patient medication record, so called opt-out system was selected. This means that if the patient does not express his/her disagreement with the viewing, the doctor, pharmacist or clinical pharmacist may view the patient´s medication record. All granted or withdrawn consents are filed by the Consent Administration component of the ePrescription system that was launched on 1 December 2019. The patient has the right to express his/her universal disagreement with doctors or pharmacists viewing his/her medication record. Equally, the patient may grant an explicit consent only to a selected specific doctor or pharmacist. Parents also have the right to express disagreement with the doctor or pharmacist viewing the shared record of their children.
The settings of the consents or disagreements as desired by the patient may be entered in the patient web application, or communicated via the patient´s data mailbox or a letter with an officially authenticated signature.
The viewing of the patient´s medication record proper will be possible from June 2020. Concurrently with the launch of the shared medication record, it will be possible to utilise also a control of duplicate prescription of medicinal products.
Another amendment to the ePrescription system was conducted due to the newly established reimbursement of medical cannabis from health insurance. From 1 January 2020, the ePrescription system provides support in registering the dispensed cannabis in the amount of 30 g with a 90 % reimbursement from public health insurance. This change was associated with the complete change of cannabis prescription codes, registration of both maximum dispensing limits (the existing maximum dispensed amount of 180 g per month and the new maximum amount of cannabis with a 90 % price reimbursement from the public health insurance) as well as amendment of the services for pharmacists who, when dispensing cannabis, have to distinguish whether they dispense cannabis subject to reimbursement or not.
A substantial change implied by the effective legislation is the obligation to digitalise hard-copy prescriptions in the pharmacy. This functionality is completely new and for the purposes of digitalised prescription (electronic dispensing record) filing, it was necessary to prepare new services for the pharmacists and health insurance companies who obtain information about digitalised prescriptions for the purposes of determination of reimbursement for these activities for the pharmacies.
Legislation implied also minor changes that had to be reflected in the ePrescription system by 1 January 2020. This concerns the discontinuation of two-item prescriptions – as of 1 January 2020, ePrescriptions may bear one item at the most, and as of 1 June 2020 this shall apply also to hard-copy prescriptions. The validity of a prescription has been united to 14 days; and patient contact data (telephone or address of residence) during illness were added to the ePrescription. Furthermore, web and mobile applications were amended so as to meet the currently effective legislative requirements.
In addition to legislative changes, as of 1 January 2020, a new functionality for the delivery of important information on medicinal products was deployed. This will result in enhanced information provision to doctors, pharmacists as well as the patients. Via the ePrescription system, it is possible to display information relevant to the medicinal product being prescribed or dispensed. This concerns primarily educational materials, DHPC or other important information.