A.V. Matveev 1,2, A.Ye. Krasheninnikov1, E.A. Egorova2, E.I. Konyaeva2

1 — Autonomous Nonprofit Organization «National Scientific Center for Pharmacovigilance» 127051, Russian Federation, Moscow, Malaya Sukharevskaya Square, 2, Bldg.2 2.
2 — The Medical Academy named after S.I. Georgievskiy of Federal State Educational Institution of Higher Professional Education named after V.I. Vernadsky, 295051, Russian Federation, Simferopol, Blvd. Lenina 5/7

The widespread use of β-lactam antibiotics of the penicillin group in practical medicine and their officially allowed prescription to special categories of patients (children, pregnant and lactating women, the elderly) requires serious attention to the study of safety and risk assessment in antibacterial pharmacotherapy.


The aim of the work was a retrospective study of cases of adverse reactions (ADRs), as well as the identification and analysis of problems associated with the use of drugs (Drug-related problems, DRPs) of the penicillin group.

Materials and methods

The objects of the study were cases of ADR development when using a group of penicillinsin inpatient and outpatient facilities, as well as when using drugs as self-medication, i.e. ADR notification cards registered in the regional (Republic of Crimea) database of spontaneous reports ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period 2009-2018. DRPswere studied and analyzed using the updated version of the DRP qualification system PCNE (Pharmaceutical Care Network Europe Foundation) V9.0.

Results and discussion

The results of the analysis of ADR cards revealed that amoxicillin-clavulanate and amoxicillinwere the «leading» drugs in terms of the frequency of ADR development. It is worth noting the high incidence of ADR development against the background ofpenicillin use in pediatric patients (from 0 to 18 years) 142 cases. The clinical manifestations of ADR to the presented group of antibiotics were drug hypersensitivity reactions (309 cases), dyspeptic disorders (28 cases), and central nervous system disorders (5 cases). The incidence of severe ADR was 113 cases (33% of the total reactions), indicating a fairly high risk of developing severe ADR when using penicillins, accompanied by a significant reduction in patients’ quality of life.


The detection of DRPusing the PCNE V9.0 method is an important and promising tool necessary to improve the quality of patients’ pharmacotherapy and their adherence to treatment. The highest DRPvalues were observed with amoxicillin-clavulanateand amoxicillin, indicating a high frequency of irrational prescribing of these drugs.

List of abbreviations:

DRPdrug-related problems; MP medicinal products; INN international nonproprietary name; ADR adverse reactions; CA causality assessment