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Analysis of Spontaneous Reports as a Methodological Pharmacovigilance Tool

https://doi.org/10.33647/2074-5982-18-2-40-45

Abstract

This article deals with the problem of undesirable drug reactions (UDR), having particular importance for both pharmacology and the healthcare system as a whole. Up-to-date information on the global prevalence of UDR is presented. A methodological approach to monitoring UDR based on a system of spontaneous reporting (SR) is proposed. An analysis of SR on UDR registered in the Rostov region in 2020 is conducted.

About the Authors

T. S. Litvinenko
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



A. V. Safronenko
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 Dr. Sci. (Med.), Assoc. Prof.

  344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



Yu. S. Maklyakov
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 Dr. Sci. (Med.), Prof. 

 344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



E. V. Gantsgorn
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 Cand. Sci. (Med.), Assoc. Prof.

  344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



E. S. Postnikova
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 Cand. Sci. (Med.), 

 344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



M. O. Gaisaev
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



V. G. Brizhak
Rostov State Medical University of the Ministry of Health Care of Russia
Russian Federation

 344022, Russian Federation, Rostov–on–Don, Nakhichevansky Lane, 29 



References

1. Glagolev S.V., Gorelov K.V., Chizhova D.A. Razvitie sistemy farmakonadzora v Rossijskoj Federacii [Development of the pharmacovigilance system in the Russian Federation]. Vestnik Roszdravnadzora [Bulletin of Roszdravnadzor]. 2019;(2):72–77. (In Russian).

2. Zhuravleva M.V., Romanov B.K., Gorodetskaya G.I., Muslimova O.V., Krysanova V.S., Demchenkova E. Yu. Aktual’nye voprosy bezopasnosti lekarstvennyh sredstv, vozmozhnosti sovershenstvovaniya sistemy farmakonadzora [Topical issues of drug safety, possibilities of improving of pharmacovigilance]. Bezopasnost’ i risk farmakoterapii [Safety and risk of pharmacotherapy]. 2019;7(3):109–119. (In Russian). DOI: 10.30895/2312-7821-2019-7-3-109-119.

3. Litvinenko T.S., Safronenko A.V., Gantsgorn E.V., Dyatchina L.I., Zamlelaya I.V., Myakota I.M., Bystrovskij V.O. Nezhelatel’nye pobochnye reakcii kak aktual’naya problema fundamental’noj i klinicheskoj farmakologii [Undesirable side reactions as an urgent problem of fundamental and clinical pharmacology]. Biomedicina [Journal Biomed]. 2020;16(3):115–119. (In Russian). DOI: 10.33647/2074-5982-16-3-115-119.

4. Shubnikova E.V., Darmostukova M.A., Bukatina T.M., Kaperko D.A., Velts N.Yu., Kazakov A.S., Snegireva I.I., Zhuravleva E.O., Kutekhova G.V. O zaregistrirovannyh v postmarketingovyj period nezhelatel’nyh reakciyah lekarstvennyh sredstv [The adverse drug reactions registered during the postmarketing period]. Bezopasnost’ i risk farmakoterapii [Safety and risk of pharmacotherapy]. 2019;7(1):15–22. (In Russian). DOI: 10.30895/2312-7821-2019-7-1-15-2.

5. Ahern F., Sahm L.J., Lynch D., McCarthy S. Determining the frequency and preventability of adverse drug reaction-related admissions to an Irish University Hospital: A cross-sectional study. Emerg. Med. J. 2014;31(1):24–29. DOI: 10.1136/emermed-2012-201945.

6. Akbari Sari A., Doshmangir L., Torabi F., Rashidian A., Sedaghat M., Ghomi R., Prasopa-Plaizier N. The incidence, nature and consequences of adverse events in Iranian hospitals. Arch. Iran Med. 2015;18(12): 811–815.

7. Bénard-Laribière A., Miremont-Salamé G., PéraultPochat M-C., Noize P., Haramburu F., EMIR Study Group on behalf of the French network of pharmacovigilance centres. Incidence of hospital admissions due to adverse drug reactions in France: The EMIR study. Fundam. Clin. Pharmacol. 2015;29:106–111. DOI: 10.1111/fcp.12088.

8. https://apps.who.int/iris/handle/10665/22589

9. Leendertse A.J., Visser D., Egberts A.C.G., van den Bemt P.M.L.A. The relationship between study characteristics and the prevalence of medication-related hospitalizations: A literature review and novel analysis. Drug Saf. 2010;33(3):233–244. DOI: 10.2165/11319030-000000000-00000.

10. Pedrós C., Quintana B., Rebolledo M., Porta N., Vallano A., Arnau J.M. Prevalence, risk factors and main features of adverse drug reactions leading to hospital admission. Eur. J. of Clin. Pharmacol. 2014;70(3):361–367. DOI: 10.1007/s00228-013-1630-5.


Review

For citations:


Litvinenko T.S., Safronenko A.V., Maklyakov Yu.S., Gantsgorn E.V., Postnikova E.S., Gaisaev M.O., Brizhak V.G. Analysis of Spontaneous Reports as a Methodological Pharmacovigilance Tool. Journal Biomed. 2022;18(2):40-45. (In Russ.) https://doi.org/10.33647/2074-5982-18-2-40-45

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ISSN 2074-5982 (Print)
ISSN 2713-0428 (Online)