Pharmacotherapy’s safety audit at the outpatient clinic level

   Objective: to analyze the structure of drug prescriptions and adverse drug reactions (ADRs) in the conditions of application of the developed risk-based approach to the audit of pharmacotherapy in patients of outpatient clinics.

   Materials and methods: the basis for the study was an outpatient clinic in Rostov-on-Don. The sample consisted of 680 patients observed by a general practitioner. Based on the results of a retrospective analysis of spontaneous reports of ADRs registered in the Rostov region for 2019-2021, a risk-based questionnaire was developed. 50 % (n = 340) of the observed patients were surveyed and, depending on the results, pharmacotherapy was adjusted; the other half of the patients (n = 340) were not questioned and received standard pharmacotherapy. Statistical processing of the results was carried out on a PC using the LibreOffice Calc software package and IBM SPSS Statistics v. 26.

   Results: the overall incidence of ADR development in outpatient clinics was 7.5 % (4.5 % and 8.2 %, respectively) (p < 0.05). Patients who underwent a risk-based audit of drug prescriptions had higher rates of the psychological component of health (84.8 ± 3.2 versus 73.2 ± 2.4, respectively) (ρ = 0.386; p = 0.01), the physical component of health (78.3 ± 2.6 versus 69.4 ± 1.8, respectively) (ρ = 0.493; p = 0.01), less drug burden (3.1 ± 1.4 versus 5.3 ± 2.1, respectively) (ρ = 0.452; p = 0.01), the number of unscheduled visits to a therapist (by 24 % on average), the incidence of serious ADRs (by 18 %) (ρ = 0.949; p = 0.01), additional treatment costs (by 23 % on average) (ρ = 0.334; p = 0.01).

   Conclusions: the results of the study can be used for further, including pharmacoeconomic studies, to improve the safety of drug therapy, avoid the “cascade of drug prescriptions” and improve the quality of life of specialized patients in outpatient clinics.

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