The preparation for the pharmacovigilance system audit

2021-05-25T00:04:09+03:00

The pharmacovigilance system audit – is the regular, ordered, independent and documented process of collecting the information and impartial assessment of the facts, which represents the functioning of the pharmacovigilance system [1]. The main goal of conducting the pharmacovigilance system audit is the confirmation of compliance, implementation and functioning efficacy of the pharmacovigilance system through [...]

The preparation for the pharmacovigilance system audit2021-05-25T00:04:09+03:00

The pharmacovigilance system inspection procedure

2021-05-25T00:02:34+03:00

The inspection is the external test. The inspection on compliance with pharmacovigilance requirements by the market authorization holders is carried out by the regulatory bodies of the EAEU state-members. The pharmacovigilance inspections should be held by the inspectors, appointed by the national regulatory bodies, authorized to hold the examination of the indoor space, to get [...]

The pharmacovigilance system inspection procedure2021-05-25T00:02:34+03:00

PROBLEM OF INSUFFICIENT INVOLVEMENT OF POPULATION INTO PHARMACOVIGILANCE SYSTEM

2021-05-24T23:34:52+03:00

Aim. To ground the necessity of taking into account the double-component nature of the phenomenon of poor activity of the population in the system of pharmacovigilance so as to work out the measures, aimed at development of UR reporting. The process of formation of a modern system of pharmacovigilance in Russia with appropriate level of reporting on the cases [...]

PROBLEM OF INSUFFICIENT INVOLVEMENT OF POPULATION INTO PHARMACOVIGILANCE SYSTEM2021-05-24T23:34:52+03:00

ADVERSE REACTIONS OF ACE INHIBITORS. RETROSPECTIVE ANALYSIS OF SPONTANEOUS REPORTS IN LOCAL DATABASE

2021-05-22T13:00:38+03:00

Abstract Among the diseases of the cardiovascular system, arterial hypertension due to the significant prevalence of the disease, a high risk of complications and low patient compliance takes a special place. One of the most important factors playing a role in the pathogenesis of hypertension is the activation of the renin-angiotensin-aldosterone system. Angiotensin-converting enzyme inhibitors [...]

ADVERSE REACTIONS OF ACE INHIBITORS. RETROSPECTIVE ANALYSIS OF SPONTANEOUS REPORTS IN LOCAL DATABASE2021-05-22T13:00:38+03:00

Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan

2021-05-22T12:38:09+03:00

This article is devoted to the study of the organization of pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan. To achieve this goal, an expert assessment of the experience of post-marketing pharmacovigilance activities and a survey in relation to messages on the safety and effectiveness of drugs were carried out, post-marketing pharmacovigilance activities at [...]

Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan2021-05-22T12:38:09+03:00

The role of pharmacists in the organization of the pharmacovigilance system in the Republic of Kazakhstan

2021-05-16T16:21:43+03:00

This article is devoted to assessing the role of pharmacists in the pharmacovigilance system of the Republic of Kazakhstan. For this, the method of questioning the employees of pharmacy organizations was used, during which the insignificant role of pharmacists in the pharmacovigilance system of the Republic of Kazakhstan was revealed, which is the reason for [...]

The role of pharmacists in the organization of the pharmacovigilance system in the Republic of Kazakhstan2021-05-16T16:21:43+03:00

ANALYSIS OF SPONTANEOUS REPORTS OF ADVERSE REACTIONS IN PATIENTS WITH CORONARY ARTERY DISEASE IN THE REPUBLIC OF CRIMEA

2021-05-16T16:13:13+03:00

Aim: To analyze spontaneous reports of adverse drug reactions in patients with coronary artery disease in the Republic of Crimea for the five-year period from January 2011 to August 2016. Methods: 332 reports of adverse drug reactions in patients with coronary artery disease collected in the “ARCADe” database were analyzed. Out of them, 231 reports on essential drugs affecting the cardiovascular system were [...]

ANALYSIS OF SPONTANEOUS REPORTS OF ADVERSE REACTIONS IN PATIENTS WITH CORONARY ARTERY DISEASE IN THE REPUBLIC OF CRIMEA2021-05-16T16:13:13+03:00

PHARMACOVIGILANCE AS AN EFFECTIVE TOOL FOR IMPROVING QUALITY MANAGEMENT OF PHARMACEUTICAL ACTIVITIES: STAGES OF DEVELOPMENT AND PERSPECTIVES

2021-05-16T15:37:55+03:00

There are a few stages in development of global pharmacovigilance system. These stages include evolution from establishment of first regional institutions such as Food and Drug Administration in USA in 1862 to formation of international systems for adverse drug reactions monitoring (i.e. WHO collaborating center in Sweden Uppsala Monitoring Center); from local regulatory acts, such [...]

PHARMACOVIGILANCE AS AN EFFECTIVE TOOL FOR IMPROVING QUALITY MANAGEMENT OF PHARMACEUTICAL ACTIVITIES: STAGES OF DEVELOPMENT AND PERSPECTIVES2021-05-16T15:37:55+03:00

THE ROLE OF «OFF-LABEL» PRESCRIPTIONS AS A FACTOR OF ADVERSE DRUG REACTION IN PEDIATRIC PRACTICE

2021-05-16T15:35:12+03:00

A significant role in the development of adverse drug reactions in childhood belongs to ignoring officially approved instructions for medication use. The main medications prescribed «off-label» are cephalosporins; most frequent in pediatric practice are cases of an irrational choice of doses, and also violation of the drug introduction schedule. In order to improve the quality of drug therapy in childhood further development and improvement of the pharmacological surveillance system is necessary.

THE ROLE OF «OFF-LABEL» PRESCRIPTIONS AS A FACTOR OF ADVERSE DRUG REACTION IN PEDIATRIC PRACTICE2021-05-16T15:35:12+03:00

COMPARATIVE ANALYSIS OF THE CARDS-NOTICES OF ADVERSE DRUG REACTIONS

2021-05-16T13:58:19+03:00

Matveev A.V., Krasheninnikov A.E., Egorova E.A. Timely high-quality detection, collection and analysis of information on adverse drug reactions is possible only with the presence and active functioningof pharmacovigilance system. One of the most effective methods used to control drug safety is the system of registration and analysis of spontaneous reports. The article is devoted to [...]

COMPARATIVE ANALYSIS OF THE CARDS-NOTICES OF ADVERSE DRUG REACTIONS2021-05-16T13:58:19+03:00
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