Legal issues of introducing ketamine-assisted therapy in Ukraine

International practice shows that ketamine therapy is a fairly progressive direction in the treatment of mental and behavioural disorders and pain syndromes. Back in the 1970s, the scientific literature first reported on ketamine as a drug that has a therapeutic effect on depression and can become an effective alternative to traditional antidepressants, which were gradually exhausting their potential.

In Ukraine, ketamine is registered and used as an anaesthetic agent (monotherapy) for short-term diagnostic procedures and surgical interventions in children and in some special cases in adults: induction of anaesthesia and maintenance of anaesthesia. The special indications for the use of ketamine (alone or in combination with another drug) are as follows painful procedures (changing a dressing in a patient with burns); neurodiagnostic procedures (pneumoencephalography, ventriculography, myelography); endoscopy; some procedures in ophthalmology; diagnostic and surgical interventions in the neck or oral cavity; dental treatment; otolaryngological interventions; gynaecological extraperitoneal interventions; interventions in obstetrics, anaesthesia for caesarean section; interventions in orthopaedics and traumatology; anaesthesia in patients in shock and hypotension due to the peculiarities of ketamine's effect on the heart and blood circulation; anaesthesia in patients who prefer intramuscular administration of the drug (e.g. children).

Instead, on 28 April 2017, the Order of the Ministry of Health of Ukraine No. 1422 dated 29 December 2016 came into force, which allows Ukrainian doctors to use international clinical protocols and guidelines in their work. According to the Order of the Ministry of Health of Ukraine № 751 dated 28.09.2012, a clinical guideline is a document containing systematic provisions on medical and medical and social care developed using the methodology of evidence-based medicine based on confirmation of their reliability and validity, and is intended to assist a doctor and patient in making rational decisions in various clinical situations. Clinical guidelines can be approved as new clinical protocols based on the principles of evidence-based medicine and developed according to existing methods by national and/or professional medical associations of the European Union member states (membership is determined as of 1 January 2017), the United States of America, Canada and the Australian Union. The guidelines should be available in English and/or Ukrainian.

At the same time, healthcare facilities have the right to choose and translate protocols on their own. Such protocols, approved by an internal order of the healthcare facility, are allowed to be used in its work.  This approach is based on Article 77 of the Law of Ukraine "Fundamentals of the Legislation of Ukraine on Healthcare", Order of the Ministry of Health of Ukraine No. 751 of 28 September 2012 "On the creation and implementation of medical and technological documents for the standardisation of medical care in the system of the Ministry of Health of Ukraine" (as amended) on the introduction of modern methods of treatment into medical practice, improvement of the quality and effectiveness of medical care for patients, the right to free choice of approved forms, methods and means of.

According to the official information from the Ministry of Health, the translation of new clinical protocols does not need to be approved by the Department of Health or other institutions. A relevant internal order of the medical institution is sufficient for the doctors of the medical institution to officially use them. However, such protocols can only be used in the institution where they were approved.

A healthcare facility where a new clinical protocol is to be used or a sole proprietorship has the right to translate a clinical guideline included in the list of sources (Annex 4 to the Order of the Ministry of Health of Ukraine No. 751 dated 28 September 2012 "On the development and implementation of medical and technological documents for standardisation of medical care in the system of the Ministry of Health of Ukraine") and approve the translation as a new clinical protocol by an internal order. The translation and approval of new clinical protocols can be carried out by healthcare institutions, private practitioners, as well as the Ministry of Health of Ukraine, if it is necessary to implement new clinical protocols.

The key evidence-based protocol for the use of ketamine not only as an anaesthetic but also as a medicine in the treatment of mental, behavioural and pain disorders is the clinical guideline "Ketamine and esketamine for treating unipolar depression in adults: Administration, efficacy, and adverse effects" (included in the Up To Date database, Internet address http://www.uptodate.com, and the list of sources of clinical guidelines in Annex 4 to the Methodology for the development and implementation of medical standards of care based on evidence-based medicine).

Subject to the approval of the translation of this guideline as a new clinical protocol based on evidence-based medicine, an informed consent form and a patient pathway at the primary level of care, every healthcare facility that implements the relevant forms of treatment can be guided by the provisions of this recommendation. This opens the way to treating military personnel for depression with progressive ketamine therapy in appropriate healthcare facilities.