Study of the safety of antianemic preparations by method of the system of problems related to medicinal preparations

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Iron deficiency is the most common micronutrient deficiency worldwide. Prevention and treatment of iron deficiency conditions are some of the most important health problems in many countries of the world. At the same time, the main problems for it remain the timely diagnosis, elimination of the cause, as well as the choice of replacement therapy with iron-containing drugs and correction of adverse reactions (ADR) that occur during their use.

The aim. This research aims to study the peculiarities of the development of antianaemic drugs ADRs in patients living in the territory of the Republic of Crimea.

Materials and methods. The objects of research were cases of ADR occurrence associated with the use of a group of antianaemic drugs and revealed during the 2009-2018 period in the territory of the Republic of Crimea. The main tasks in the analysis of notification forms were the study of the ADR severity, the causality assessment for suspected drugs and ADRs, as well as analysis of particular problems associated with the use of antianaemic drugs (Drug-related problems, DRP).

Results. Iron supplements in combination with other drugs became the leaders in the incidence of ADR among antianaemic drugs (28 cases, 42.4% of all cases of ADR). The largest number of cases was registered in patients aged from 18 to 30 years, with female patients prevailing. Among the clinical manifestations of ADR, the most cases were drug hypersensitivity reactions of varying severity (40 cases) and disorders of the gastrointestinal tract (18 cases). The study of the problems associated with the use of antianaemic drugs made it possible to determine that the highest rates of DRP values were observed with the use of iron preparations for parenteral use and cyanocobalamine. The minimal DRP values were observed when prescribing iron protein succinylate preparations.

Conclusion. The basis of pharmacotherapy for various types of anemias is the replenishment of iron and vitamin B12 (cyanocobalamin) depots. The effectiveness of the treatment in these cases largely depends on the patient’s adherence to treatment, which is, in turn, depends on the frequency and severity of ADRs that occur during the use of antianaemic drugs.

作者简介

Alexander Matveev

Medical Academy named after S.I. Georgievsky (structural unit) Crimean Federal University named after S.I. Vernadsky; Russian Medical Academy of Continuing Professional Education

编辑信件的主要联系方式.
Email: avmcsmu@gmail.com
ORCID iD: 0000-0002-6636-3950

ndidate of Sciences (Medicine), Associate Professor of the Department of Basic and Clinical Pharmacology

俄罗斯联邦, 5/7, Lenin Bul., Simferopol, Republic of Crimea, 295051; Bld. 1, 2/1, Barrikadnaya St., Moscow, 125993

Elena Egorova

Medical Academy named after S.I. Georgievsky (structural unit) Crimean Federal University named after S.I. Vernadsky

Email: elena212007@rambler.ru
ORCID iD: 0000-0003-4012-2523

Candidate of Sciences (Pharmacy), Associate Professor of the Department of Basic and Clinical Pharmacology

俄罗斯联邦, 5/7, Lenin Bul., Simferopol, Republic of Crimea, 295051

Elena Koniaeva

Medical Academy named after S.I. Georgievsky (structural unit) Crimean Federal University named after S.I. Vernadsky

Email: konyaeva.simferopol@gmail.com
ORCID iD: 0000-0001-5301-8608

Candidate of Medical Sciences (Medicine), Associate Professor of the Department of Internal Medicine No1 with a course of Clinical Pharmacology

俄罗斯联邦, 5/7, Lenin Bul., Simferopol, Republic of Crimea, 295051

Elvira Bekirova

Medical Academy named after S.I. Georgievsky (structural unit) Crimean Federal University named after S.I. Vernadsky

Email: elvira8300@mail.ru
ORCID iD: 0000-0003-4097-2376

Candidate of Medical Sciences, Associate Professor of the Department of Dermatovenereology and Cosmetology

俄罗斯联邦, 5/7, Lenin Bul., Simferopol, Republic of Crimea, 295051

Leniе Adzhimamutova

Medical Academy named after S.I. Georgievsky (structural unit) Crimean Federal University named after S.I. Vernadsky

Email: lenie.ajimamutova@yandex.ru
ORCID iD: 0000-0001-7498-723X

5th year student

俄罗斯联邦, 5/7, Lenin Bul., Simferopol, Republic of Crimea, 295051

参考

  1. McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993–2005. Public Health Nutr. 2009 Apr;12(4):444–54. doi: 10.1017/S1368980008002401.
  2. Zhorova VE, Khilkevich EG. Incidence and prevalence of iron deficiency anaemia. Meditsinskiy sovet = Medical Council. 2018;(13):78–81. doi: 10.21518/2079-701X-2018-13-78-81. Russian
  3. Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383.
  4. Zakharova IN, Tarasova IS, Chernov VM, Machneva EB, Lazareva SI, Vasil’eva TM. Risk Factors of Development of Iron-Deficiency Conditions in Moscow Adolescents. Pediatricheskaya farmakologiya — Pediatric pharmacology. 2015; 12 (5): 609–613. doi: 10.15690/pf.v12i5.1464. Russian
  5. DeLoughery TG. Safety of Oral and Intravenous Iron. Acta Haematol. 2019; 142 (1): 8–12. doi: 10.1159/000496966.
  6. Muñoz M, Gómez-Ramírez S, Bhandari S. The safety of available treatment options for iron-deficiency anemia. Expert Opin Drug Saf. 2018; 17 (2): 149–159. doi: 10.1080/14740338.2018.1400009.
  7. Avni T, Bieber A, Grossman A, Green H, Leibovici L, Gafter-Gvili A. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015; 90 (1): 12–23. doi: 10.1016/j.mayocp.2014.10.007.
  8. Zhuravleva MV, Romanov BK, Gorodetskaya GI, Muslimova OV, Krysanova VS, Demchenkova EYu. Topical issues of drug safety, possibilities of improving of pharmacovigilance. Safety and Risk of Pharmacotherapy. 2019; 7(3):109–119. doi: 10.30895/2312-7821-2019-7-3-109-119.
  9. Stephens’ Detection of New Adverse Drug Reactions, 5th Edition. Wiley. 2004. 762 p.
  10. Ruths S, Viktil KK, Blix HS. Classification of drug-related problems. Tidsskr nor Laegeforen. 2007; 127: 3073–3076.
  11. Fog AF, Kvalvaag G, Engedal K, Straand J. Drug-related problems and changes in drug utilization after medication reviews in nursing homes in Oslo, Norway. Scandinavian journal of primary health care. 2017; 35 (4): 329–335. doi: 10.1080/02813432.2017.1397246.
  12. Szilvay A, Somogyi O, Meskó A, Zelkó R, Hankó B. Qualitative and quantitative research of medication review and drug-related problems in Hungarian community pharmacies: a pilot study. BMC Health Serv Res. 2019; 19 (1): 282. doi: 10.1186/s12913-019-4114-1 11-19.
  13. Basger BJ, Moles RJ, Chen TF. Application of drug-related problem (DRP) classification systems: a review of the literature. Eur J Clin Pharmacol. 2014; 70: 799–815. doi: 10.1007/s00228-014-1686-x.
  14. Ma SN, Zaman Huri H, Yahya F. Drug-related problems in patients with rheumatoid arthritis. Ther Clin Risk Manag. 2019; 15: 505–524. doi: 10.2147/TCRM.S194921.
  15. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934; 26: 404–413.
  16. Zaichenko HV, Lytkin DV. Oral and parenteral iron drugs in patients with severe iron deficiency anemia. Reproductive endocrinology. 2015; 4(24): 30–36.
  17. Szebeni J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Rampton D, Weiss G, Folkersen J. Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management. Br J Pharmacol. 2015; 172 (21): 5025–36. doi: 10.1111/bph.13268.
  18. Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Szebeni J, Weiss G. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014; 99 (11): 1671–6. doi: 10.3324/haematol.2014.111492.
  19. Govindappagari S, Burwick RM. Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis. Am J Perinatol. 2019; 36 (4): 366–376. doi: 10.1055/s-0038-1668555.
  20. DeLoughery TG. Iron Deficiency Anemia. Med Clin North Am. 2017 Mar;101(2):319–332. doi: 10.1016/j.mcna.2016.09.004.
  21. Thong B, Tan T. Epidemiology and risk factors for drug allergy. Br. J. Clin. Pharmacol. 2011; 71 (5): 684-500.
  22. Kropova OE, Shindina TS, Maximov ML, Galyavich AS, Aleksandrova EB. Therapy of iron-deficiency anemia in geriatric practice. RMJ. 2020; 9: 59–64. Russian.
  23. Kazakov AS. The determination of confidence of cause-and-effect relation «untoward reaction-medicinal agents interaction». RMJ. 2013; 5: 38–43. Russian
  24. Alazzam S, Alzoubi KH, AbuRuz S, Alefan Q. Drug-related problems in a sample of outpatients with chronic diseases: a cross-sectional study from Jordan. Ther Clin Risk Manag. 2016; 12: 233–239. doi: 10.2147/TCRM.S98165.
  25. Groenveld HF, Januzzi JL, Damman K, van Wijngaarden J, Hillege HL, van Veldhuisen DJ, van der Meer P. Anemia and mortality in heart failure patients a systematic review and meta-analysis. J Am Coll Cardiol. 2008; 52(10): 818–27. doi: 10.1016/j.jacc.2008.04.061.
  26. Goodnough LT. Iron deficiency syndromes and ironrestricted erythropoiesis (CME). Transfusion. 2012; 52 (7): 1584–1592. doi: 10.1111/j.15372995.2011.03495.x.
  27. Walters BA, Van Wyck DB. Benchmarking iron dextran sensitivity: reactions requiring resuscitative medication in incident and prevalent patients. Nephrol Dial Tranplant. 2005; 20(7): 1438–1442. doi: 10.1093/ndt/gfh811.
  28. Morales Mateluna CA, Scherer Hofmeier K, Bircher AJ. Approach to hypersensitivity reactions from intravenous iron preparations. Allergy. 2017; 72(5): 827–830. doi: 10.1111/all.13106.
  29. Szebeni J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S. Hypersensitivity to intravenous iron: classification, terminology, mechanisms and management. Br J Pharmacol. 2015; 172: 5025–5036.
  30. Stojanovic S, Graudins LV, Aung AK, Grannell L, Hew M, Zubrinich C. Safety of Intravenous Iron Following Infusion Reactions. J Allergy Clin Immunol Pract. 2021; 9(4): 1660–1666. doi: 10.1016/j.jaip.2020.11.028.
  31. Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Szebeni J, Weiss G. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014; 99(11): 1671–6. doi: 10.3324/haematol.2014.111492.
  32. Nathell L, Gohlke A, Wohlfeil S. Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures. Drug Saf. 2020; 43 (1): 35–43. doi: 10.1007/s40264-019-00868-5.
  33. Qassim A, Gergis RG, Jeffries B, Grivell RM, Grzeskowiak LE. Use of intravenous iron polymaltose in the management of iron deficiency in pregnancy: A retrospective cohort study. Aust N Z J Obstet Gynaecol. 2018; 58 (2): 63–169. doi: 10.1111/ajo.12645.

补充文件

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1. JATS XML
2. Figure 1 – Distribution of antianemia drugs ADRs in accordance with the age categories of patients

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3. Figure 2 – Distribution of antianemia drugs ADRs in accordance with their clinical manifestations. Note: * – central nervous system, # – musculoskeletal disorders

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4. Figure 3 – Distribution of antianemia drugs ADRs in accordance with the degree of reliability of the causal relationship by the Naranjo and Karch F.E.-Lasagna L. algorithms

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版权所有 © Matveev A.V., Egorova E.A., Konyaeva E.I., Bekirova E.Y., Adjimamutova L.A., 2021

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