Hospital Pharmacology (Jan 2015)

The availability of reliable information about medicines in Serbia for health professionals summary of product characteristics

  • Đukić Ljiljana C.,
  • Terzića Branka M.

DOI
https://doi.org/10.5937/hpimj1501225D
Journal volume & issue
Vol. 2, no. 1
pp. 225 – 234

Abstract

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Introduction Today, there are many drugs for the treatment of a large number of indicator areas. Significant financial resources are invested in research with the aim of introducing reliable therapeutics to therapy. Therefore, it is necessary to provide health care professionals exact information about new therapies. The overall process of scientific data, ideas and information exchange is possible through numerous communications of modern IT tools. Methodology According to the Law, key information on registered drug is included in the Summary of Product Characteristics (SPC) for health professionals, which is harmonized with EU directives and regulations (SmPC).Protocol content and structure of the information provided in SPC is determined in the guidelines of the EU, therefore, a unique set of data is established for all the drugs registered in Serbia. Topic This paper presents the key segments of SPC, with special reference to the description of the regulations that are required for data related to indications, mechanism of action, dosage, contraindications, side effects, interactions and other important information regarding the profile of the drug, which are standardized and harmonized with the structure of identical documents which operate at the EU level, or EMEA. Conclusions SPC is the regulatory determined technical document on medicinal products in the RS in which there are listed scientifically proven, clinical and pharmacological data and information on the profile of the drug, which are essential for health professionals - doctors and pharmacists in the implementation of pharmacotherapy in our society. This document is the starting point for the development of applied Pharmacoinformatics and it includes a range of activities important for the development of appropriate manuals and makes available data and information for monitoring indicators of the national policy on drugs and modern effective drugs treatment.

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