The role of the general practitioner in detecting side effects in the application of anticancer drugs


DOI: https://dx.doi.org/10.18565/therapy.2022.4.23-30

Zhuchkova S.M., Busalaeva E.I., Karamalikov S.A.

1) Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Chuvash Republic, Cheboksary; 2) I.N. Ulyanov Chuvash State University, Cheboksary; 3) Institute of Postgraduate Medical Education of the Ministry of Healthcare of the Chuvash Republic, Cheboksary
Abstract. The duties of a therapist who monitors cancer patients at their place of residence include monitoring the safety of ongoing therapy.
The purpose of the study is to explore the structure of adverse reactions in the application of anticancer drugs in the Chuvash Republic.
Material and methods. The work is based on the retrospective analysis of 2980 spontaneous reports of adverse reactions received from September 1, 2008 to January 1, 2022 to the Chuvash regional center for drug safety monitoring.
Results. Over the past period, 79 reports of adverse reactions of anticancer drugs were registered, which is 2,65% of the total number of all notifications received. The great majority (71%) of them were identified and documented by a therapist at the outpatient stage in patients receiving medicine assistance. There were 38 cases of adverse reactions of aromatase inhibitors, 5 cases with the use of monoclonal antibodies, 3 reports each with antiestrogen treatment and taxanes in combination with platinum preparations. The most commonly developed dermatological toxicity of varying intensity (83%), cardiovascular toxicity (8%), hematological toxicity (2%), febrile neutropenia (3%), anaphylactic shock (2%), hepatotoxicity (2%). There were no cases of renal toxicity, immune-mediated adverse reactions, extravasation of anticancer drugs. Over the past period, 5 death notices were received. The causal relationship in these cases is doubtful; death occurred from the progression of the underlying disease. 1 death associated to an anaphylactic reaction to intake of the combination of paclitaxel + carboplatin. The article provides brief descriptions of clinical cases.
Conclusion. Despite the increase in the intake of anticancer drugs, a significant increase in the frequency of registration of adverse reactions in the Chuvash Republic has not been identified. The main number of reports was submitted by outpatient general practitioners who supervise oncological patients in medical organizations at the place of residence.

Literature


1. Правила надлежащей практики фармаконадзора Евразийского экономического союза. Доступ: https://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87 (дата обращения – 27.04.2022). [Good Pharmacovigilance Practice Rules of the Eurasian Economic Union. https://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87 (date of access – 27.04.2022) (In Russ.)].


2. Федеральный закон от 12.04.2010 № 61-ФЗ «Об обращении лекарственных средств». Доступ: http://www.consultant.ru/document/cons_doc_LAW_99350 (дата обращения – 27.04.2022). [Federal Law of April 12, 2010 No. 61-FZ «On the Circulation of Medicines». URL: http://www.consultant.ru/document/cons_doc_LAW_99350 (date of access – 27.04.2022) (In Russ.)].


3. Тарасова Л.В. Жучкова С.М., Бусалаева Е.И. Информированность врачей Чувашской Республики о проблеме неблагоприятных побочных эффектов лекарственных средств. Медицинский альманах. 2017; 1: 91–94. [Tarasova L.V., Zhuchkova S.M., Busalaeva E.I. Awareness of doctors of the Chuvash Republic about the problem of adverse side effects of medicines. Meditsinskiy almanakh = Medical Almanac. 2017; 1: 91–94 (In Russ.)].


4. Жучкова С.М., Дубов В.В., Бусалаева Е.И. с соавт. Осведомленность врачей Чувашской Республики о проблеме неблагоприятных побочных реакций лекарственных средств. В кн.: Спешите делать добро: материалы межрегиональной научно-практической конференции. Чебоксары. 2016; с. 59–61. [Zhuchkova S.M., Dubov V.V., Busalaeva E.I. et al. Awareness of doctors of the Chuvash Republic about the problem of adverse drug reactions. In the book: Hurry to do good: materials of the interregional scientific and practical conference. Cheboksary. 2016; pp. 59–61 (In Russ.)].


5. Edwards I.R., Beriell C. Harmonisation in pharmacovigilance. Drug Saf. 1994; 10(2): 93–102. https://dx.doi.org/10.2165/00002018-199410020-00001.


6. Определение степени достоверности причинно-следственной связи «неблагоприятная побочная реакция – лекарственное средство» (классификация и методы). Методические рекомендации Росздравнадзора (утв. 02.10.2008). Доступ: https://docs.cntd.ru/document/499043554 (дата обращения – 27.04.2022). [Determination of the degree of reliability of the causal relationship «adverse reaction – drug» (classification and methods). Methodological recommendations of Roszdravnadzor (approved on 02.10.2008). URL: https://docs.cntd.ru/document/499043554 (date of access – 27.04.2022) (In Russ.)].


7. Приказ Федеральной службы по надзору в сфере здравоохранения от 15.02.2017 № 1071 «Об утверждении порядка осуществления фармаконадзора». Доступ: https://rg.ru/2017/03/23/roszdravnadzor-prikaz1071-site-dok.html (дата обращения – 27.04.2022). [Order of the Federal Service for Surveillance in Healthcare of February 15, 2017 No. 1071 «On approval of the procedure for the implementation of pharmacovigilance». URL: https://rg.ru/2017/03/23/roszdravnadzor-prikaz1071-site-dok.html (date of access – 27.04.2022) (In Russ.)].


8. Клинические рекомендации Ассоциации онкологов России. Доступ: https://oncology-association.ru/clinical-guidelines (дата обращения – 27.04.2022). [Clinical guidelines of the Association of Oncologists of Russia. URL: https://oncology-association.ru/clinical-guidelines guidelines (date of access – 27.04.2022) (In Russ.)].


9. Трякин А. А., Бесова Н. С., Волков Н. М. с соавт. Практические рекомендации по общим принципам проведения противоопухолевой лекарственной терапии. Злокачественные опухоли. 2017; 3s2: 26–39. [Tryakin A. A., Besova N. S., Volkov N. M. et al. Practical recommendations on the general principles of anticancer drug therapy. Zlokachestvennye opukholi = Malignant Tumors. 2017; 3s2: 26–39 (In Russ.)]. https://dx.doi.org/10.18027/2224‑5057‑2020‑10‑3s2–01.


10. Ивашкин В.Т., Барановский А.Ю., Райхельсон К.Л. с соавт. Лекарственные поражения печени (клинические рекомендации для врачей). Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2019; 1: 101–131. [Ivashkin V.T., Baranovsky A.Yu., Raikhelson K.L. et al. Drug-induced liver injuries (clinical guidelines for physicians). Rossiyskiy zhurnal gastroenterologii, gepatologii, koloproktologii = Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2019; 1: 101–131 (In Russ.)]. https://dx.doi.org/10.22416/1382-4376-2019-29-1-101-131.


11. Ткаченко П. Е., Ивашкин В. Т., Маевская М. В. Клинические рекомендации по коррекции гепатотоксичности, индуцированной противоопухолевой терапией. Злокачественные опухоли. 2020; 3s2: 67–80. [Tkachenko P. E., Ivashkin V. T., Maevskaya M. V. Clinical guidelines for the correction of hepatotoxicity induced by anticancer therapy. Zlokachestvennye opukholi = Malignant Tumors. 2020; 3s2: 67–80 (In Russ.)]. https://dx.doi.org/10.18027 / 2224-5057-2020-10-3s2-40.


12. Протоколы клинических рекомендаций поддерживающей терапии в онкологии. 2-е изд., перераб. и доп. М.: АБВ-пресс. 2018; с. 99–113. [Protocols of clinical guidelines for maintenance therapy in oncology. 2nd ed., rev. and add. Moscow: ABV-press. 2018; pp. 99–113 (In Russ.)].


13. Клинические рекомендации: лекарственные поражения печени у взрослых. Терапия. 2020; 4: 52–76. [Clinical guidelines: drug-induced liver injury in adults. Terapiya = Therapy. 2020; 4: 52–76 (In Russ.)]. https://dx.doi.org/10.18565/therapy.2020.5.52-76.


14. Конопацкова О.М., Аверьянова С.В. Сопроводительная терапия при проведении полихимиотерапии колоректального рака. Онкология. Журнал им. П.А. Герцена. 2016; 1: 42–46. [Konopackova O.M., Averiaanova S.V. S Adjunct therapy during combination chemotherapy for colorectal cancer. Onkologiya. Zhurnal im. P.A. Gertsena = P.A. Herzen Journal of Oncology. 2016; 1: 42–46 (In Russ.)]. https://dx.doi.org/10.17116/onkolog20165142-46.


15. Конопацкова О.М., Аверьянова С.В. Применение Ремаксола при полихимиотерапии у пациентов с раком молочной железы. Онкология. Журнал им. П.А. Герцена. 2015; 6: 35–37. [Konopackova O.M., Averianova S.V. Use of Remaxol in the polychemotherapy of patients with breast cancer. Onkologiya. Zhurnal im. P.A. Gertsena = P.A. Herzen Journal of Oncology. 2015; 6: 35–37 (In Russ.)]. https://dx.doi.org/10.17116/onkolog20154635-37.


About the Autors


Svetlana M. Zhuchkova, PhD in Medicine, head of the Department of clinical pharmacology, Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Chuvash Republic, associate professor of the Department of faculty and hospital therapy, I.N. Ulyanov Chuvash State University. Address: 428003, Cheboksary, 23 Fedora Gladkova Str. E-mail: crista007@mail.ru. ORCID: https://orcid.org/0000-0002-2295-1363
Elwna I. Busalaeva, PhD in Medicine, associate professor of the Department of therapy and family medicine, Institute of Postgraduate Medical Education of the Ministry of Healthcare of the Chuvash Republic. Address: 428003, Cheboksary, 27 Mikhaila Sespelya Str. E-mail: busa-elena@yandexl.ru. ORCID: https://orcid.org/0000-0001-7313-0365
Sergey A. Karamalikov, chief physician of Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Chuvash Republic. Address: 428003, Cheboksary, 23 Fedora Gladkova Str. E-mail: rkod@med.cap.ru.
ORCID: https://orcid.org/0000-0002-4993-2832


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