The issue of increasing the availability of narcotic and psychotropic drug products for patients who need them for medical reasons in the context of developing palliative care in the Russian Federation and due to its high social significance is under special control of the Government of the Russian Federation, executive authorities and civil society.
A comprehensive approach in this direction is provided under the Action Plans (“roadmaps”), namely, “Increasing the availability of narcotic and psychotropic drug products for medical use” (approved by the Order of the Government of the Russian Federation No. 1403-r dated July 01, 2016) and “Increasing the quality and accessibility of palliative care” by 2024 (approved by the Deputy Chairman of the Government of the Russian Federation T.A. Golikova, No. 6551p-P12, July 28, 2020).
An important factor affecting the quality of palliative care is the availability of anesthetics, including centrally-acting analgesics. At the end of life, moderate to severe pain is experienced by 80% of cancer and AIDS patients, 67% of patients with cardiovascular disease or chronic obstructive pulmonary disease*. When it comes to palliative patients with severe convulsive states, they often require continuous drug therapy.
For a patient, the possibility to receive adequate anesthesia is stipulated by part 5 of Article 19 of Federal Law No. 323-FZ dated November 21, 2011 “On the Fundamentals of Health Protection of the Russian Citizens”. According to its provisions, “a patient has the right to relieve pain associated with a disease and (or) medical intervention by available methods and medicines, including narcotic and psychotropic drug products, when receiving medical care guaranteed by the program of free medical care for citizens.”
As a co-executor of the roadmaps, FSUE Endopharm continuously monitors the completeness of the selection of narcotic drug products (hereinafter referred to as “ND”) listed by the constituent entities of the Russian Federation within their declared needs in accordance with the plan for the allocation of narcotic drug products and psychotropic substances approved annually by the Ministry of Industry and Trade of the Russian Federation. FSUE Endopharm uses this information for the preparation of a report to the Administration of the President of the Russian Federation and the Government of the Russian Federation. In addition, FSUE Endopharm develops and advances new drug products required for the implementation of the roadmap.
Since the beginning of 2023, FSUE Endopharm has participated in meetings with the executive authorities of the constituent entities of the Russian Federation in the field of health protection regarding the development of the palliative care system, monitoring of the implementation of regional programs for the development of palliative care, analysis of the implementation of the Roadmap benchmarks in six federal districts of the Russian Federation: Volga region (29. 03.03.2023), North Caucasus (22.03.2023), Central (12.04.2023), Southern (23.05.2023), North-West (14.06.2023) and Ural (26.07.2023) regions.
On July 5, 2023, a meeting of the specialized commission of the Ministry of Health of the Russian Federation on palliative care was held in St. Petersburg within the IX St. Petersburg International Oncological Forum “White Nights”. At this Forum, Lyudmila Shershakova, Adviser to the CEO of FSUE Endopharm, reported on the benchmarks of the roadmap achieved in the first half of 2023.
Reported demand and sampling size for non-invasive narcotic analgesics are trending up 1% and 2% respectively for the first 7 months of 2023 compared to the same period in 2022.
Being a leader in the production of centrally-acting analgesics, FSUE Endopharm provides manufactured narcotic and psychotropic drug products without inventory shortage to all regions of the Russian Federation in accordance with the Allocation Plan approved by the Ministry of Industry and Trade of the Russian Federation.
The task of the Company is to ensure the availability of the entire line of manufactured drug products for the consumer, including under the conditions of unpredictable international market relations. In cooperation with the Ministry of Industry and Trade of the Russian Federation, FSUE Endopharm is implementing a major investment project to organize large-scale production of active pharmaceutical ingredients (API) and cultivation of plant raw materials to fully localize the production of socially significant anesthetics in the country. The design of the production facility, which is scheduled to be commissioned in 2026, is being finalized this month.
At the same time, the Company is organizing sites for low-tonnage production of API, primarily required for the production of narcotic and psychotropic drug products. The release of three pharmaceutical ingredients is already underway. Their capacity makes it possible to cover the current demand of the Russian Federation for these APIs. Sites for the production of two more APIs will be operational by the end of this year, the other two - in early 2024. The development of 6 APIs is progressing well: developed laboratory series are at the stage of stability studies and preparation of finished dosage forms.
Professional training of medical workers in the provision of palliative care, including management (monitoring) of chronic pain syndrome, remains among the urgent tasks of the roadmap to form and improve practical skills in high-quality pain management.
As part of the implementation of paragraph 13 of the Minutes of the meeting on increasing the availability and quality of analgesic therapy in the provision of palliative care under the chairmanship of the Minister of Health of the Russian Federation M.A. Murashko dated April 26, 2022, FSUE Endopharm and the Federal Scientific and Practical Center for Palliative Care under the Federal State Autonomous Educational Institution of Higher Education (FSPCPC under FSAEIHE) I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation held a series of educational seminars. Those seminars, namely, “Current issues of treatment of chronic pain syndrome for adults in need of palliative care,” were organized to improve the level of professional competencies of medical specialists in Tula (April 7, 2023), Kostroma (May 18, 2023) and Makhachkala (August 3, 2023). The participants of the events received relevant knowledge on modern classification and diagnosis of chronic pain syndrome types, socio-psychological aspects of pain treatment, principles and algorithms of therapy of chronic pain syndrome, available nomenclature of medicines for palliative care. Particular attention was paid to the regulatory framework for prescribing narcotic drug products and psychotropic substances and the methodology for estimating requirements. The specialists also discussed and exchanged experience in managing complex clinical cases, shared best practices in organizing the availability and quality of anesthesia in the provision of palliative care.
In cooperation with FSUE Endopharm and supported by the Association of Hospice Care Providers and the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade held a series of regional educational seminars aimed at raising awareness among medical specialists of new forms of psychotropic drug products for the management of convulsive seizures in pediatric epilepsy within the VIII Educational Palliative Medical Forum in Yaroslavl (February 21, 2023), Stavropol (March 23, 2023), Novosibirsk (April 25, 2023) and Petrozavodsk (May 25, 2023).
Measures taken jointly at the federal and regional levels by the executive authorities, the professional medical community, socially orientated non-profit organizations and FSUE Endopharm made it possible to achieve a 10-fold** increase in the availability of non-invasive narcotic drug products in the constituent entities of the Russian Federation and in the number of patients who received adequate pain relief in 2022 compared to 2014.
*Pallium: Palliative and Hospice Care, Russian Research and Practical Journal, No. 2, June 2022.
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