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Рецензент: д.фарм.н., доц. Р.В. Сагайдак-Нікітюк
Національний фармацевтичний університет (Харків)
Национальный фармацевтический университет (Харьков)
National University of Pharmacy
Monitoring of the safety of medicines in their medical use is a major focus in the realization of the national pharmaceutical policy all over the world.
The level of development of the national monitoring system to the safety of medicines depends on the amount and quality of information about adverse reactions which coming from various sources.
The main tasks of monitoring is to collect, analyze and systematize of information about adverse reactions, dissemination of data on the pharmacological properties of medicines, their safety use, and research work on the development of methods and standards for determining risk and benefit during pharmacotherapy.
It is assumed that the received data on volume of pharmacotherapy, the number of adverse reactions and elimination of their consequences will reduce the costs of methods of covering or additional treatment, the acceptance of appropriate regulatory decisions, improvement the quality of pharmacotherapy.
The final purpose is optimization of financial costs of treatment and improvement the quality of medical and pharmaceutical care.
Also in the outpatient treatment a district doctor does not always have feedback from the patient and in case of adverse reaction a patient often stops taking medications without notice.
This means that many cases of adverse reactions simply not taken into account and, accordingly, there is a need to advance the existing system for the most complete data collection.
In connection with the above, the purpose of investigation was the development of approaches and recommendations to improve the data collection about adverse reaction with outpatients or in self.
The author notes that the presence of modern information technology in the drug stores easily allow to pharmacist / clinical pharmacist to collection and to consolidation of relevant information .
Special forms for to pharmacist / clinical pharmacist for identification adverse reactions, which has some differences from the established by Ukraine’s Ministry of Health special forms for reporting adverse reactions, were proposed. This allows to identify the medicine which provoked adverse reactions and to determine its form promptly, directly at the drugstore, even in the absence of information and resources that are at the doctor (medical card, medical history, test results, pharmacotherapy ...).
Information can be recorded as the electronic map of the patient (for a more rational pharmacotherapy) and come to the clinic databases.
Graphs for adverse reaction manifestation in different body systems (gastrointestinal, nervous, etc.), for age and sex of respondents, for possible diagnosis, for patient’s pharmacotherapy are provided in this form.
Of course, the error of reliability degree is much increased, but due to mass character we can see the messages that would never have come to a specialist.
An algorithm for detecting and recording adverse events together with prescription monitoring increase the degree of spontaneous reports to the pharmacovigilance’s centers, will contribute to a more complete and accurate information about the range of adverse reactions, their rate of development, the identification of rare, unexpected and serious reaction, the timely development of risk management strategy in pharmaceutical care and measures for the effective and safe use of medicines.
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