Apteka.ua, No. 13 (1184), 8 April 2019
Since April 1st, 2019 within the government program “Affordable Medicines” medicines have been released based on electronic prescriptions. All other medicines will be released based on electronic prescription from 2020. Such know-how introduction for Ukraine is taking place within the healthcare reform and transfer to eHealth. Electronic prescription intends to relieve doctors from the obligation to issue hand-written prescriptions, reduce the number of mistakes, save working time, and enable medical prescriptions tracking, medicines movement and patient compliance with treatment. Dmytro Aleshko, partner at Legal Alliance Company, and Alina Lebedeva, assistant associate at Legal Alliance Company, told Weekly Pharmacy editors about peculiarities of electronic prescription introduction in Ukraine, its opportunities and risks.
— As we know, eHealth system is being introduced in Ukraine. Such changes are without doubt requirements of the modern world, which is constantly digitalizing and developing. What are the key principles of eHealth system in Ukraine and does the modern Ukrainian society need these know-how in your opinion?
D.А.: The world is developing. In particular, it is proven by the fact that it is heading towards introduction of online procedures and rapid exchange of information. In some countries, for example, even voting takes place via the Internet.
Therefore, digitalization is of course an important part for development of healthcare in Ukraine. EHealth system model is based on advanced experience of foreign countries.
Let me note that eHealth is not only about electronic prescriptions, it is information and telecommunication system which will contain the following components:
In the long-term perspective the system is aimed at simplifying life to all the process participants: from first care doctor to pharmacist. The system will become a source of reliable statistical data, facilitate accessibility and transparency of healthcare services and also anticorruption tool.
А.L.: Of course, at the first stage of eHealth introduction we face non-acceptance of this mechanism. It is clear that it can have objective reasons: more time is required to issue a prescription since doctors are not used to the new system, or there will be queues in pharmacies during release of medicines based on electronic prescriptions.
However, I believe these to be temporary inconveniences in the transitional period like during introduction of any other reform. Due to the system transparency the government can manage calculation processes which will contribute to budget funds saving for their redistribution on healthcare measures of bigger priority.
We should also stress priority of comprehensive system of information protection, which is contained in the central database of the electronic healthcare system.
—Which opportunities does eHealth open for the domestic market?
D.А.: Most data to be included to the system has either never been unified or has been stored in paper form. Electronic healthcare system is called to unite registers of medical facilities, doctors and patients in such a way that information on major events taking place in eHealth can be available for system analysis. It will be a basis for getting potential opportunities for development of new products and services by commercial entities.
Thus, based on systematization of these data and their audit it will be possibleto create more topical offers on the market, new projects in the healthcare sector and services which will provide qualitative analysis of such information and form optimal conclusions based on them.
At the same time, the government will be able to track population health condition which will contribute to further policy formation by healthcare state authorities by objective determination of funding priorities.
Experience of European countries has demonstrated that use of electronic healthcare systems contributes to increasing medical services quality. Thus, eHealth employment grants the following advantages:
А.L.: According to numbers, the program of telecommunication development in Scotland allowed saving about 78.6 million pounds within 5 year period (2006-2011) due to faster discharge of patients from healthcare facilities, avoiding hospitalization and reducing home-based consultations.
World electronic healthcare systems open opportunities of easy data exchange among healthcare facilities of different levels, which has already been introduced in numerous countries. Furthermore, trans-border exchange of information on patients and electronic prescriptions has become possible. The most famous in this aspect is European project - European Patient Smart Open Services (epSOS) covering 23 countries. Its aim is to provide healthcare professionals with major information on patient disease record and care provided to them.
In a lot of cases timely access to such information can save patient’s life (in case a patient is allergic to some medicines, chronical diseases, etc.) in this case exchange of data takes place observing patient personal data protection.
— Which normative changes does the introduction of electronic healthcare system, including electronic prescription, require? Which changes have been implemented as for today and which aspects still require harmonizing?
D.А.: Currently major normative aspects for introduction of eHealth system have been approved. Normative basis of eHealth functioning includes the following:
The necessary changes regarding introduction of electronic prescription have been made to Order of the Ministry of Health No. 360 as of July 19th, 2005. Thus, prescriptions of form 1 and form 3 can also be issued as electronic prescriptions.
Considering the electronic healthcare system is introduced in several stages, further it will be necessary to pass regulatory acts necessary for its functioning at the secondary (specialized), tertiary (highly specialized) and other types of medical care. When electronic prescriptions are introduced as mandatory for all medicines, and not only for those subject to reimbursement, it will be necessary to make the corresponding changes in order to make issue of paper prescriptions impossible.
Furthermore, given transformation in the healthcare system of Ukraine, both as regards introduction of e-prescriptions and public procurement of medicines through electronic procurement system, now it is necessary to integrate and coordinate various electronic and information systems with the State Register of Medicines of Ukraine.
The corresponding draft resolution of the Cabinet of Ministers of Ukraine developed with the participation of Legal Alliance Company has been put on public discussion on the website of the ministry. Thus, the draft resolution of the Cabinet of Ministers of Ukraine “On Making Changes to the Regulation on the State Register of Medicines” prescribes to ensure unification of introducing information on medicines to the Register in accordance with the national standards adopted based on the international standards developed by ISO. Such changes will facilitate harmonization of regulatory acts of Ukraine and EU practice.
— Electronic prescriptions is planned as mandatory only for Affordable Medicines program now. Does the legislation allow issuing prescriptions on medicines beyond the program?
А.L.: Indeed, now it has been decided to introduce pilot electronic prescription for Affordable Medicines program. It is due to outpatient program nature, limited number of active substances and coordinated mechanism of interaction with pharmacies.
The important aspect of e-prescription introduction is that they will enable patients to get medicines in any Ukrainian pharmacy which has an agreement with the National Healthcare Service of Ukraine regardless of the place of its issue.
According to the law, from January 1st, 2020 state guarantees of medical care to the population under the corresponding program will be implemented for all types of medical care. Respectively, electronic prescription for all medicines guaranteed by the state will function from that time.
D.А.: Here we should also pay attention to the fact that electronic healthcare system includes central database and electronic medical information systems between which automatized exchange of information, data and documents through open program interface must be ensured. Owner of the central database is the state represented by the National Healthcare Service of Ukraine, including of property rights to its software. Administrator of the central database is Electronic Health State Enterprise.
Moreover, beyond Affordable Medicines program, for which electronic prescription issue is settled for today, such prescriptions can be issued not only in eHealth system.
The Rules of Issuing Prescriptions for Medicines and Medical Products approved by Order of the Ministry of Health No. 360 as of July 19th, 2005 provide that electronic prescription is created, stored and transferred through information (information and telecommunication) system. Electronic healthcare system created by the state today is in line with such characteristics.
However, the legislation today does not prohibit creation of other information (information and telecommunication) systems, which would enable issue, storage and transfer of electronic prescriptions. For healthcare sector it is crucial that healthcare facilities can issue electronic prescriptions in an alternative system, and pharmacies will issue medicines based on such a prescription.
— In your opinion, what are weaknesses of eHealth which is being introduced in Ukraine? Which challenges for healthcare sector does e-prescription introduction entail? What should concerned parties pay attention to today?
А.L.: I believe that weaknesses generally are due to need in computers and uninterrupted access to the Internet in healthcare facilities, in particular, pharmacies. Besides, the corresponding software is required. For some facilities, especially in rural areas, it will be a challenge.
During eHealth introduction in Ukraine analysis and consideration of mistakes made in other countries are very important.
Thus, some of the major problems faced by European states is strong threat of hacker attacks on electronic healthcare systems. Cyberattacks or so-called cybertheft are possible, when offenders steal patient data and use them for illegal medicine purchase for sale thereof on black market or commission of other illegal actions.
Thus, Trend Micro Incorporated, global leader for cybersecurity solutions development, has conducted analysis which demonstrated that only in 2015 113.2 million medical records were stolen and used for illegal medicine purchase, tax fraud and commission of other illegal actions.
D.А.: In Ukraine special attention should be paid to the issue of data security in eHealth system. It is the biggest challenge.
Information protection in central database is based on legislation for protection of information in information and telecommunication systems, and personal data processing in electronic healthcare system is carried in accordance with the Law of Ukraine “On Personal Data Protection”.
The Law of Ukraine “On State Financial Guarantees of Medical Care to the Population” establishes that access to patient data is possible only upon consent of the latter (except for cases of direct threat to the patient life, impossibility of obtaining consent of this patient or his representatives and upon court decision).
The system administrator is obliged to protect information contained in the central database. In case operator violates requirements for ensuring information protection, administrator can stop access of the electronic medical information system to the central database or even disconnect such system from the central database.
The process of development of components of electronic healthcare system involved professionals for cybersecurity of several independent companies which carried a number of audits on cybersecurity issue. It has been established that data center complies with international standards (compliance certificate ISO 27001:2013 issued by Bureau Veritas No. IND17.0398/U) and Ukrainian standards (compliance certificate No. 14162 as of 22.07.2016) in data protection sector.
Of course, we should not stop at this. Improvement of protection system should be constant and follow new challenges of electronic world.
Press service of Apteka.ua Weekly
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