AboutContactsEditorial StaffEditorial CouncilArchiveFor AuthorsFor Reviewers

Legal Aspects of Pain Management for Patients with Chronic Pain Syndrome

Journal «MEDICINA» ¹ 1, 2025, pp.47-57 (Research)

Authors

Abuzarova G. R.
Doctor of Medicine, Professor, Head, Palliative Care Center1; Professor, Chair for Oncology and Palliative Medicine2

Fedorov A. A.
Expert3

Volchkov D. A.
Lawyer4

1 - P. Hertsen Moscow Oncology Research Institute (MORI), Moscow, Russian Federation
2 - Russian Medical Academy of Continuing Professional Education, Moscow, Russian Federation
3 - Russian Union of Patients Public Societies, Moscow, Russian Federation
4 - IMPID LLC, Moscow, Russian Federation

Corresponding Author

Volchkov Dmitrii, e-mail: info@irmfi.org

Conflict of interest

None declared.

Funding

The study had no sponsorship.

Abstract

In this article, an interdisciplinary group of authors examines the legal and clinical aspects of pain management in cancer patients belonging to clinical groups II–III. Special attention is given to the use of effective chronic pain syndrome therapy with opioid analgesics, as opposed to prescribing nonsteroidal anti-inflammatory drugs. At the same time, the regulatory barriers to prescribing effective pain therapy are explored, which stem from the lack of clinical guidelines for treating chronic pain syndrome in patients of clinical groups II–III.

Key words

chronic pain syndrome, palliative care, opioid analgesics, legal regulation, regulatory barriers

DOI

References

1. Standarty i innovacii v lechenii bolevogo sindroma u onkologicheskih pacientov. [Standards and innovations in the treatment of pain syndrome in cancer patients.] Nacional'naya onkologicheskaya programma 2030 [National Cancer Program 2030] 2023; (2): 50-57. (In Russ.)

2. WHO Guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents. Available at: https://www.who.int/publications/i/item/9789241550390

3. Prikaz Ministerstva zdravoohraneniya Rossijskoj Federacii ot 28 fevralya 2019 g. ¹ 104n «Ob utverzhdenii poryadka i srokov odobreniya i utverzhdeniya klinicheskih rekomendacij, kriteriev prinyatiya nauchno-prakticheskim sovetom resheniya ob odobrenii, otklonenii ili napravlenii na dorabotku klinicheskih rekomendacij libo resheniya ob ih peresmotre» (s izmeneniyami i dopolneniyami). Prilozhenie ¹ 1. «Poryadok i sroki odobreniya i utverzhdeniya klinicheskih rekomendacij». [Order of the Ministry of Health of the Russian Federation No. 104n dated February 28, 2019 «On Approval of the Procedure and Deadlines for Approval and Approval of Clinical recommendations, criteria for making a decision by the Scientific and Practical Council on approval, rejection or referral for revision of clinical recommendations or a decision on their revision» (with amendments and additions). Appendix No. 1. «Procedure and terms of approval and approval of clinical recommendations».] (In Russ.)

4. Federal'nyj zakon ot 21.11.2011 ¹ 323-FZ (red. ot 08.08.2024, s izm. ot 26.09.2024) «Ob osnovah ohrany zdorov'ya grazhdan v Rossijskoj Federacii» (s izm. i dop., vstup. v silu s 01.09.2024). [Federal Law No. 323-FZ of 11/21/2011 (as amended on 08/08/2024, as amended dated 09/26/2024) «On the basics of public health protection in the Russian Federation» (with amendments and additions, intro. effective from 09/01/2024).] (In Russ.)

5. Klinicheskie rekomendacii «Hronicheskij bolevoj sindrom (HBS) u vzroslyh pacientov, nuzhdayushchihsya v palliativnoj medicinskoj pomoshchi». [Clinical guidelines «Chronic pain syndrome (CFS) in adult patients in need of palliative care».] Moscow: Ministry of Health of the Russian Federation, 2023. (In Russ.)

6. Federal'nyj zakon ot 21.11.2011 ¹ 323-FZ (red. ot 28.12.2024) «Ob osnovah ohrany zdorov'ya grazhdan v Rossijskoj Federacii» (s izm. i dop., vstup. v silu s 01.03.2025), St. 37. [Federal Law No. 323-FZ of 11/21/2011 (as amended on 12/28/2024) «On the Fundamentals of Public Health Protection in the Russian Federation» (as amended and supplemented, intro. effective from 03/01/2025), Art. 37.] (In Russ.)

7. «Ob utverzhdenii standarta palliativnoj medicinskoj pomoshchi vzroslym pri hronicheskom bolevom sindrome (diagnostika i lechenie)». Proekt. [«On approval of the standard of palliative care for adults with chronic pain syndrome (diagnosis and treatment)». Draft.] Available at: https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=144905 (In Russ.)

8. Prikaz Minzdrava Rossii ot 24.11.2021 N 1094n «Ob utverzhdenii Poryadka naznacheniya lekarstvennyh preparatov, form recepturnyh blankov na lekarstvennye preparaty, Poryadka oformleniya ukazannyh blankov, ih ucheta i hraneniya, form blankov receptov, soderzhashchih naznachenie narkoticheskih sredstv ili psihotropnyh veshchestv, Poryadka ih izgotovleniya, raspredeleniya, registracii, ucheta i hraneniya, a takzhe Pravil oformleniya blankov receptov, v tom chisle v forme elektronnyh dokumentov». (Zaregistrirovano v Minyuste Rossii 30.11.2021 N 66124). P. 5. [Order of the Ministry of Health of the Russian Federation dated 11/24/2021 N 1094n «On approval of the Procedure for Prescribing Medicines, forms of prescription forms for medicines, the Procedure for Registration of these forms, their Accounting and storage, forms of prescription forms containing the appointment of narcotic drugs or psychotropic substances, the Procedure for their manufacture, distribution, registration, accounting and storage, as well as the Rules of registration prescription forms, including in the form of electronic documents.» (Registered with the Ministry of Justice of Russia on 11/30/2021 N 66124). Item 5.] (In Russ.)

9. Prikaz Ministerstva zdravoohraneniya Rossijskoj Federacii i Ministerstva truda i social'noj zashchity Rossijskoj Federacii ot 31 maya 2019 g. ¹ 345n/372n «Ob utverzhdenii Polozheniya ob organizacii okazaniya palliativnoj medicinskoj pomoshchi, vklyuchaya poryadok vzaimodejstviya medicinskih organizacij, organizacij social'nogo obsluzhivaniya i obshchestvennyh ob”edinenij, inyh nekommercheskih organizacij, osushchestvlyayushchih svoyu deyatel'nost' v sfere ohrany zdorov'ya». St. 12. [Order No. 345n/372n of the Ministry of Health of the Russian Federation and the Ministry of Labor and Social Protection of the Russian Federation dated May 31, 2019 «On Approval of the Regulations on the Organization of Palliative Care, including the Procedure for Interaction between medical organizations, social Service organizations and public associations, and other non-profit organizations operating in the field of health protection.». Art. 12.] (In Russ.)

10. Prikaz Ministerstva zdravoohraneniya Rossijskoj Federacii ot 19 fevralya 2021 g. ¹ 116n «Ob utverzhdenii Poryadka okazaniya medicinskoj pomoshchi vzroslomu naseleniyu pri onkologicheskih zabolevaniyah». P. 8 Prilozheniya ¹ 8; P. 10 Prilozheniya ¹ 5. [Order of the Ministry of Health of the Russian Federation No. 116n dated February 19, 2021 «On approval of the Procedure for providing medical care to the adult population with oncological diseases.» Item 8 of Appendix No. 8; Item 10 of Appendix No. 5.] (In Russ.)

11. Prikaz Ministerstva zdravoohraneniya Rossijskoj Federacii ot 19 fevralya 2021 g. ¹ 116n «Ob utverzhdenii Poryadka okazaniya medicinskoj pomoshchi vzroslomu naseleniyu pri onkologicheskih zabolevaniyah». P. 8 Prilozheniya ¹ 5. [Order of the Ministry of Health of the Russian Federation No. 116n dated February 19, 2021 «On approval of the Procedure for providing medical care to the adult population with oncological diseases.» Paragraph 8 of Appendix No. 5.] (In Russ.)

12. Klinicheskie rekomendacii «Rak pishchevoda i kardii» Razdel 3.3. [Clinical recommendations «Cancer of the esophagus and cardia» Section 3.3.] Moscow: Ministry of Health of the Russian Federation, 2024. (In Russ.)

13. Federal'nyj zakon ot 21.11.2011 ¹ 323-FZ (red. ot 28.12.2024) «Ob osnovah ohrany zdorov'ya grazhdan v Rossijskoj Federacii» (s izm. i dop., vstup. v silu s 01.03.2025). St. 19, pp 4,5. [Federal Law No. 323-FZ of 11/21/2011 (as amended on 12/28/2024) «On the Fundamentals of Public Health Protection in the Russian Federation» (as amended and supplemented, intro. effective from 03/01/2025). Art. 19, paragraphs 4.5.] (In Russ.)

14. Naznachenie i oformlenie naznacheniya narkoticheskih i psihotropnyh lekarstvennyh preparatov, drugih preparatov dlya medicinskogo primeneniya, podlezhashchih predmetno-kolichestvennomu uchetu oborot narkoticheskih sredstv, psihotropnyh veshchestv i ih prekursorov, Informacionno-metodicheskie materialy. [Prescription and registration of prescription of narcotic and psychotropic drugs, other drugs for medical use, subject to quantitative accounting, turnover of narcotic drugs, psychotropic substances and their precursors, Information and methodological materials.] Moscow. 2024. Available at: https://www.endopharm.ru/upload/iblock/8bb/3msqkuv4m024ok56r6s2vkdw022yzisj.pdf