Electronic Prescription for Medicines Became Closer

23/ 05/ 2018

The Ministry of Health of Ukraine adopted Order No. 735 as of April 18th, 2018 amending several orders of the Ministry of Health which regulate issue and circulation of prescriptions and also the procedure for dispending prescribed medicines. The order is registered with the Ministry of Justice, but it will become effective only upon its official publication.

All the mentioned changes are actually aimed at creating sufficient legislative base to lauch electronic prescription.

The first block of changes is related to the Rules for Issuing Prescriptions for Medicines and Medical Products approved by Order of the Minsitry of Health No. 360 as of July 19th, 2005.

Unlike the current edition, the new one expands a list of entities which can issue prescriptions for medicines and medical products released on special payment conditions. Thus, under the new edition prescriptions for drugs which a patient gets on privileged terms, for free or with additional payment, or the cost of which is subject to state reimbursement (fully or partly) can be prescribed by doctors of healthcare facilities of all forms of ownership and subordination upon approval by healthcare units of state local administrations. Now this right is enshrined only for medicines subject to state reimbursement.

Change in requirements to prescription filling is important as well. The current version of the Rules for Prescription Issue requires a healthcare facility’s stamp and doctor’s signature and seal. Prescriptions for medicines for privileged categories of patients and for the medicines subject to reimbursement by the state also must bear an official seal of the business entity. After the changes become effective, healthcare facility stamp will not be required anymore.

The new version specified a list of data to be put in the prescription. In particular, these data include information on the healthcare facility or sole trader: healthcare facility name or first name, patronymic and last name of the sole trader, address, identification code from the Unified State Register/TIN (if any) and passport number (for individuals who due to their religious views refuse to take TIN), medical practice license details. It should be emphasized that the list is exhaustive and it is not allowed to put any other information (including advertising) on the prescription.

The Rules prescribe that additional information necessary to implement state, regional or local programs, or number of insurance policy (is necessary) can be specified in prescriptions for medicines and medical products released on privileged terms for free or for additional payment, or which are subject to state reimbursement.

A fundamental novelty of the new Rules is enshrining form of and requirements to electronic prescription. It is provided that electronic prescription will be used only in the database of the information system (that is, computer program). In other words, only a doctor authorized by a healthcare facility to work with this program will be able to change or cancel the prescription.

The electronic prescription will include analogous content information as a paper prescription No. 1 (ф-1) and will be issued for the analogous term. The new version clearly prescribes that printed electronic prescription, even if bears a doctor’s seal or facsimile, will not be considered electronic prescription. Form of prescription No. 1 (ф-1) has also been approved in the new version.

At issue of the electronic prescription a patient will be able to order additional services related to electronic prescription issue, for example notification of the prescription number through mobile connection to electronic address. Expressions used in the new Rules do not limit the list of additional services which can be offered and paid for by the patient.

Besides it is established that in case there is a mistake in electronic prescription, it is considered invalid and is cancelled in the system by a person who issued the prescription, or another authorized person.

Commercial entities alone decide whether they should adopt electronic prescription system, except for in cases established by law. The new version does not describe the cases when they will become mandatory. Draft order on changes as of April 11th, 2018 specified that it concerns medicines realized on privileged basis for free or for additional payment, or which are subject to state reimbursement.

Due to electronic prescription introduction upon entry into force of order No. 735, the Procedure for Realization of Medicines and Medical Products from Pharmacies and Their Units approved by Order of the Ministry of Health of Ukraine No. 360 as of July 19th, 2005 changed as well.

Electronic prescription will be considered invalid for the same reasons that paper prescription. However, if the pharmacy workers have discovered invalidity of an electronic prescription, unlike paper one which can be stamped as invalid and returned to the patient, pharmacy workers will record invalidity in the information system or will inform the doctor who issued the prescription of its invalidity.

Pharmacy worker authorized to work in the information pharmacy system will inform the doctor who issued the prescription of each case of realization of the medicine by the pharmacy and cases when it was realized in the quantity fewer that specified in the prescription. The fact of such realization is recorded in the information system by a pharmacy worker and is certified in the system with his electronic signature.

It is obvious that given the novelties, new additional administrative burden will be imposed on healthcare facilities, private practitioners and pharmacies. Thus, a doctor who will work in the system with electronic prescriptions or pharmacy worker will have to get electronic signature. Besides, to introduce the electronic prescription system healthcare facilities and pharmacies will have to develop some internal rules and there determine who is responsible for working in the system and procedure for accessing it.

The issue how the system of electronic prescription will work in practice remains unresolved. In particular, it is unclear whether only code will be provided to the patients, for example by e-mail or sms, by which the pharmacist will search the corresponding prescription in the client’s profile. Or maybe everyone will be granted special cards with a code, on which information on the prescription will be recorded when the doctor passes it through the reading mechanism first, and at the next pass in the pharmacy the product will be realized.

Using electronic prescription is one of E-Health elements, which is in its turn a part of medical reform which is constantly supported by the state leaders and is recognized one of the priority directions. According to developers, electronic prescriptions must provide easy access for a doctor and patient to the whole disease history and patient treatment, simplify introduction of prescription record (issue, realization, consumption) and will allow analyzing patient needs and their realization, including at the expense of state, more clearly. Ahead there is the beginning for electronic prescription circulation, where all entities will be required to do their best for possible correction of legislative algorithms based on real needs of major participants of the process: medical/pharmaceutical experts and patients.

Contact the author: Zoya Zamikhovska, associate at Legal Alliance Company, zamikhovska@l-a.com.ua

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