The possibility for the patient to receive adequate anaesthesia is fixed by part 5 of Article 19 of Federal Law No. 323-FZ dd. 21/11/2011 “On Fundamental Healthcare Principles in the Russian Federation”, according to which "the patient has the right to relief of pain associated with the disease and (or) medical intervention, available methods and drug products, including narcotic and psychotropic substances, when providing medical care to the extent guaranteed by the program of state guarantees of free provision of medical care to citizens.”
The issue of analgesic therapy availability for patients in need in Russia, due to its social significance, is under special control of the Government of the Russian Federation, executive authorities and civil society. In 2021, despite reorientation of palliative care beds and decrease of planned surgical interventions caused by the COVID-19 pandemic, the consumption of non-invasive narcotic analgesics by the subjects of the Russian Federation to provide patients in need of anaesthesia showed a 10-fold increase compared to 2014.
Effective interdepartmental cooperation is underway at the federal level to improve legislation in narcotic drugs and psychotropic substances (NDPS) trafficking. One of its results is a significant optimization of the procedure for prescribing narcotic drugs, as well as decriminalization of cases of violations of the rules narcotic drugs and psychotropic substances trafficking committed by negligence and resulting in their loss during medical activities.
Starting in 2018, the Government of the Russian Federation annually allocates additional federal funding for the organization of palliative care in every part of the country. These funds, among others, are directed to the purchase of modern dosage forms of opioid analgesics.
In April 2022, medical institutions returned to normal operation. According to the results of the monitoring conducted by FSUE “Endopharm” for 6 months of 2022, in comparison with the same period last year, there is an increase in the sample of narcotic drugs:
- in invasive dosage forms ― by 33%;
- in non-invasive long-acting dosage forms ― by 16%.
Despite the positive dynamics, in a number of the regions there is a decrease in the volume of the declared need and the sample of narcotic analgesics, in particular short-acting in non-invasive forms.
In pursuance of the Action Plan (hereinafter - “Roadmap”) No. 6551p-P12 dd. July 28, 2020 “Improving the Quality and Accessibility of Palliative Care” until 2024,” approved by Deputy Prime Minister of the Russian Federation T.A. Golikova, at the initiative of the Ministry of Health of the Russian Federation, an interdepartmental interregional meeting was held in April 2022 on improving the availability of anaesthesia in the provision of palliative care in the Russian Federation under the chairmanship of the Minister of Health of the Russian Federation M.A. Murashko. The meeting participants noted that in the context of improving palliative care in the Russian Federation, among the urgent tasks identified by the Roadmap remain:
- implementation of benchmarks in terms of the volume of the demand declared by the subjects of the Russian Federation and the completeness of the sample of medicines containing narcotic drugs and psychotropic substances by the subjects of the Russian Federation;
- development, state registration and organization of new medicines production containing NDPS, if needed;
- organization of professional training of medical personnel on the provision of palliative care, including management (control) of chronic pain syndrome in order to form and improve practical skills of high-quality anaesthesia.
Being a co-executor of the Roadmap, FSUE “Endopharm” annually expands the range of domestic narcotic and psychotropic drugs. Since 2016, the Enterprise has registered 12 new medicines used in the provision of palliative care, according to 8 international nonproprietary names (INN) in 10 dosage forms. The program of implementation of FSUE “Endopharm” until 2024 includes 6 new medicines used in the provision of palliative care.
A wide range of narcotic and psychotropic drugs currently registered in the Russian Federation make it possible to provide anaesthesia to 100% of patients in need in full in accordance with the recommendations of the Ministry of Health of the Russian Federation.
It should be noted that in order to prevent a decrease in the availability of narcotic drugs for patients in need in the current political and economic situation, FSUE “Endopharm,” in cooperation with the Ministry of Industry and Trade of Russia, is implementing a large-scale investment project to fully localize active pharmaceutical ingridients necessary for their production in the Russian Federation.
An important task in terms of increasing the availability of palliative care in the Russian Federation is the implementation of educational projects aimed at methodological and informational support of MDs.
In cooperation with the Association of Professional Participants of Hospice Care and the Federal Research and Production Center (FRPC) of Palliative Care of the I.M. Sechenov First Moscow State Medical University of the Ministry of Health of Russia (Sechenov University) FSUE “Endopharm” has developed and, according to the stated need, sent printed information materials for medical specialists “Medicines for Palliative Care” to the regions of Russia. The brochure provides information in a convenient form on the current nomenclature of medicines manufactured by the Enterprise and used for the anaesthesia of palliative patients, as well as adjuvants and symptomatic therapy, examples of registration of prescription forms for each drug, information on the Threshold Limit Value (TLV) for 1 prescription and QR code with reference to the current instructions for medical use.
In July 2022, the first stage of the educational project for the main freelance palliative care specialists, dedicated to the issues of anaesthesia, was completed. The scientific and practical seminar “Topical Issues of the Treatment of Chronic Pain Syndrome in Adult Patients in Need of Palliative Care” was organized by the Association of Professional Participants of Hospice Care and the Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation jointly with the FSUE “Endopharm.” 80 chief freelance palliative care specialists of the subjects of the Russian Federation received up-to-date knowledge on the modern classification and diagnosis of types of chronic pain syndrome, socio-psychological aspects of pain treatment, principles and algorithms of chronic pain syndrome therapy, available nomenclature of medicines for palliative care. Particular attention was paid to the issues of statutory regulation of the appointment and discharge of NDPS and the methodology for calculating the need. The specialists also discussed and exchanged experience in managing complex clinical cases, shared best practices for organizing the availability and quality of anaesthesia in palliative care.
With the support of FSUE “Endopharm,” a thematic issue of the journal “Pallium: Palliative and Hospice Care” was released (Vol.2 (15), 2022), dedicated to the issues of accessibility and quality of anaesthesia in the palliative care provision. The publication presents the following materials:
- Interdepartmental meeting on improving the availability of anaesthesia in the palliative care provision in the Russian Federation.
- Treatment of chronic pain syndrome in palliative patients in project of updated domestic recommendations.
- Chronic pain in elderly and senile patients: clinical recommendations review
- Provision of analgesic therapy for children with oncological diseases at the stage of palliative care in outpatient settings. Experience of palliative service of the charity fund “Gift of Life.” Clinical case analysis.
- A patient with chronic pain: personal choice of limiting the use of analgesics or refusing them.
- Monitoring provision of effective medical and palliative care through medications.
- Monitoring of the quality of analgesic therapy in adult patients in need of palliative care in healthcare institutions of the Samara region in 2021-2022.
- Hotline for terminally ill patients. FAQ for patients and doctors.
- Comparative clinical and economic analysis of the use of a tablet form of morphine with rapid release and an injectable dosage form in oncological patients with severe chronic pain syndrome.
- Nefopam Hydrochloride: the use of analgesic in clinical and outpatient practice (literature review).
- FSUE “Moscow Endocrine Plant”: trust of the state plus teamwork.
- “Regulatory Guillotine” of regulatory legal acts in the sphere of turnover of narcotic drugs and psychotropic substances used for medical purposes.
- Analysis of the need for palliative care among people who arrived from the territories of the Donetsk People's Republic, Luhansk People's Republic and Ukraine.
Thanks to the coordinated work carried out at the federal level by various departments, medical specialists, socially oriented non-profit organizations and FSUE “Endopharm,” today the professional medical community has tools sufficient for competent and effective anaesthesia of patients in need. At the same time, the priority task remains to work with the regions aimed at the formation and improvement of MDs' practical skills of high-quality analgesic therapy in accordance with national clinical guidelines.
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