Кyiv, September 15, 2021

The position of the Association of Representatives of International Pharmaceutical Manufacturers AIPM Ukraine regarding the draft order of the Ministry of Health of Ukraine “On Amendments to the Order of the Ministry of Health of Ukraine dated July 19, 2005 No. 360”

One of the important components of the modern reform of the healthcare system in Ukraine is the introduction of digital technologies in the creation, processing and analysis of medical data. This concerns both the medical data of patients and the resources that the country invests in the health care system. The electronic health care system (EHS), which ensures the exchange of medical information and the implementation of the program of medical guarantees for the population, was named eHealth. This system consists of a central database (DBS), which is administered by SE “Elektronne Zdrovya” and various peripheral electronic medical information systems (MISs), which automate the exchange of medical information of medical institutions with the DBS.

Understanding the importance of moving to an electronic health care system in Ukraine, we support the gradual transition to prescriptions for drugs that, according to the instructions for medical use of the drug, are subject to prescription, in the form of an electronic document – an electronic prescription.

According to the experts of the Association, the draft order clearly defines the ultimate goal of the regulatory act for the rational use of all prescription drugs and overcoming the problem of uncontrolled dispensing of prescription drugs from pharmacies without a doctor’s prescription, but there is no realistic “road map” of this process for the next 6 months

The draft order did not publish clear technical requirements for the CBD and medical information systems (MIS) of medical institutions and pharmacy networks for working in the country’s e-Health system with such electronic prescriptions. According to the latest information from the National Health Service of Ukraine, only half of the country’s pharmacies work within the framework of the national drug reimbursement program “Affordable Medicines” and have real experience of working with electronic prescriptions. It should be noted that, according to the annual report of the National Health Service of Ukraine, under the existing “Affordable Medicines” program, doctors issued and pharmacies processed about 12 million electronic prescriptions for the whole of 2020. According to expert assessment, the groups of drugs defined in the Draft Order will require more than 100 million electronic prescriptions per year, which raises significant concerns about the real possibility of scaling the system.

The transition to an electronic health care system is associated in society with ease of use and significant speed of all processes in a digital format. But the real user experience of doctors, pharmacists and patients is completely opposite – the speed of service is significantly reduced.

We will cite two specific examples that are well known to citizens of the country – the dispensing of drugs in pharmacies under the “Affordable Medicines” program and the national vaccination campaign against COVID 19.

At the beginning of the “Affordable Medicines” program, pharmacists spent 20 to 30 minutes servicing one electronic prescription. Today, it takes less time, between 7 and 15 minutes, but remains significantly longer than serving a patient without an electronic prescription.

All those who have been vaccinated against COVID 19 note that the longest queue, out of three in this process, was the queue to the ESOZ registrars! A doctor’s consultation, with a paper registration log, and the vaccination itself took a few minutes, and waiting for information to be entered in the health insurance system lasted from half an hour or more. The efficiency of using the working time of highly qualified medical staff (doctors and nurses) is a separate issue, but it is the “slow” electronic system that creates the main problem of the process.

Critical to the success of the transition to electronic prescription is a detailed assessment of the number of doctors of various specialties and medical institutions who should be able to write electronic prescriptions, the conditions for granting them access to the system, equipment for doctors and the process of training them to work with the system. Today, about 20,000 primary health care doctors (family doctors and therapists) work with electronic prescriptions under the “Affordable Medicines” program, but the groups of drugs specified in the Draft Order are prescribed by a much wider group of emergency and emergency physicians, specialists of the second and of the third link of the health care system, who, so far, do not have experience in working with an electronic prescription. Separately, we need to work on the capabilities of MIS and the doctor’s equipment for issuing an electronic prescription directly at the patient’s bedside throughout the entire territory of our country.

And the most important thing is to clearly define the goal for the EHIC: the process of issuing an electronic prescription and its service in a pharmacy should be faster or equivalent to working with a paper prescription. The real personal experience of working with the system of the doctor, pharmacy worker and patient should be positive. Unlike e-prescribing under the Affordable Medicines program, where doctors and pharmacists have a real economic motivation to provide patients with free or partially reimbursed drugs for treatment, the success of e-prescribing for drug groups specified in the Order Project will depend entirely on the practical experience of users systems.

The transition to an electronic prescription should be calculated and prepared in detail – a pilot project of such a transition should be foreseen to assess the challenges and obstacles of this process, and a duplicative mechanism of using a paper prescription to ensure a continuous treatment process and avoid artificial problems with the dispensing of prescription drugs in the pharmacy network to patients.

Taking into account the above, we make a proposal: to create a working group and hold a professional discussion with representatives of all interested market participants – doctors and medical institutions, pharmacists and distributors, drug manufacturers and market regulators in order to finalize the draft order; and determine a transitional period after 01/04/2022, during which doctors will be able to continue using paper prescriptions to ensure the treatment process and avoid artificial problems with the dispensing of prescription drugs in the pharmacy network.

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