The Ministry of Health of Ukraine offers to update legislation on prescription issues

Draft order of the Ministry of Health of Ukraine “On Amending Order of the Ministry of Health of Ukraine No. 360 as of July 19th, 2005”, the objective of which is introduction of components of electronic system of medical information exchange and continuation of electronic prescription introduction, is being on public discussion now.

According to the explanatory note to the draft act, there is an urgent need to review the legislation on circulation of medicines which orders prescription process, the procedure for releasing medicines and medical products by pharmacies, recording and disposal under the legislation of documents dedicated to circulation of medicines which are subject to additional control measures. A list of key problems in this area has been made up as follows: self-treatment; lack of doctor’s liability; incompliance with the world practice; transformation of pharmacies into sale outlets.

To solve these problems, it is offered to amend the Procedure for Release of Medicines and Medical Products by Pharmacies and Their Units (hereinafter – the Release Procedure), set out a new edition of the Rules for Prescribing Medicines and Medical Products (hereinafter – the Rules) and the Instruction for the Procedure of Storage, Recording and Disposal of Prescriptions Forms (hereinafter – the Instruction).

Some of the novelties are the following:

• Introduction of an electronic form of a special prescription form No. 3 intended for prescribing narcotic and psychotropic medicines.
• Data on maximum number of drugs to be prescribed in one prescription have been clarified.
• The norms for prescription issuance for patients with lasting and chronical diseases are being clarified.

Let us remind you that latest changes to the Rules made by Order of the Ministry of Health of Ukraine No. 735 as of April 18^th, 2018 introduced electronic prescription form No. 1 and created a lot of norms to launch electronic prescription system. A commercial entity should make a decision to introduce electronic prescribing process, except for cases when the legislation requires electronic prescription issue.

Conditions of storing prescriptions on form No. 3 (in locked drawers or safes) have been changed; liability for their storage rests not only with medical workers, but also commercial entities.

Currently proposals and remarks to the draft document are being accepted.